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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-01192 | Registry Identifier | NCI Clinical Trials Registration Program ID |
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| Name | Class |
|---|---|
| Schering-Plough | INDUSTRY |
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The main goal of this study is to estimate the tumor response rate of temozolomide administered in combination with peginterferon alfa-2b to pediatric patients with unresectable Stage III, metastatic, or recurrent cutaneous melanoma.
This study is for children with malignant melanoma and high risk features (at high risk of melanoma returning or spreading to other parts of the body) or who have recurrent disease. The study has two treatment groups based on the stage of the disease. Patients with stage IIC, IIIA or IIIB melanoma whose tumors have been removed by surgery will be treated in study group A. These patients will receive 4 weeks of high dose interferon alfa-2b followed by 48 weeks of peginterferon. Patients with stage IIIC or IV melanoma, stage III melanoma that could not be removed by surgery and those with recurrent disease will be treated in study group B. These patients will receive peginterferon alfa-2b and temozolomide.
Stratum A: Resected Stages IIC, IIIA, and IIIB patients
Induction therapy (weeks 1-4): Subjects will receive recombinant interferon alfa-2b 20 million units/m2 per day intravenously over 20-30 minutes on 5 consecutive days per week for 4 weeks. Subjects will receive peginterferon alfa-2b 1 mcg/kg/week subcutaneously for a total of 48 weeks.
Stratum B: Resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent patients
Stratum B is divided into 2 groups based on the presence (Stratum B1) or absence (Stratum B2) of measurable disease. Subjects will receive 8 weekly doses of peginterferon alfa-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75mg/m2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course will be 8 weeks. Strata B2 (no measurable disease) will proceed with 7 courses as outlined.
Surgery interventions -Associated with both Strata A and B Surgery description: All subjects with initial presentation of melanoma (T1-4) will be treated with primary wide local excision with a minimum of 1cm margin (if anatomically feasible) surrounding the primary lesion or biopsy scar. For lesions with Breslow's thickness of > 1mm or <or= with ulceration or Clark's level IV/V, a 2 cm margin is preferred when anatomically feasible. Subjects with sentinel lymph node(s) positive for disease, will undergo complete lymph node dissection of the involved nodal basin.
Additional objectives include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temozolomide/peginterferon alfa-2b | Experimental | Stratum B: Resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent patients Stratum B is divided into 2 groups based on the presence (Stratum B1) or absence (Stratum B2) of measurable disease. Subjects will receive 8 weekly doses of peginterferon alfa-2b 0.5 mcg/kg/dose subcutaneously (SQ) in combination with temozolomide 75mg/m2/dose by mouth (PO) daily for 6 weeks followed by 2 week break. The duration of each treatment course will be 8 weeks. Strata B2 (no measurable disease) will proceed with 7 courses as outlined. |
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| Peginterferon alfa-2b/non-pegylated interferon alfa-2b | Experimental | Stratum A: Resected Stages IIC, IIIA, and IIIB patients will receive recombinant interferon alfa-2b 20 million units/m2/day intravenously (IV) 5 consecutive days per week for 4 weeks followed by peginterferon alfa-2b 1mcg/kg subcutaneously (SQ) once a week for 48 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2b | Drug | Given either IV or SQ. Therapeutic drug class: interferon. |
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| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response Rate | Tumor response rate of stratum B1 participants was evaluated after 1 treatment course of temozolomide plus peginterferon ɑ-2b. Complete response (CR) and partial response (PR) confirmed with repeated scan at least 4 weeks apart following completion of course 1 therapy. CR defined as disappearance of all target and non-target lesions with no new lesions detected. If available, no disease must be detected by immunocytology or serum tumor markers. PR defined as at least 30% decrease in disease measurement compared to disease measurement at study entry with no new lesions detected. Progressive disease (PD) defined as at least 20% increase in the disease measurement compared to the smallest disease measurement recorded since start of treatment, or appearance of one or more new lesions. Stable disease defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD compared to smallest disease measurement since start of treatment. | 8 weeks |
| Number of Patients Who Experience Toxicity at or Above the Target Toxicity for Strata B1 and B2 | The objective was to assess the safety of temozolomide administered in combination with peginterferon a-2b in Stratum B participants. Accrual was suspended any time during therapy if 2 or more of 6, 4 or more of 12, 6 or more of 18, 8 or more of 24, 10 or more of 30 participants experienced target toxicity defined as:
| 52 weeks |
| Number of Patients Who Experience Toxicity at or Above the Target Toxicity for Stratum A Patients | The objective was to study the feasibility and safety of administering peginterferon a-2b weekly for 48 weeks following the initial induction phase to Stratum A participants. Accrual was suspended during the 48-week course if 2 or more of 6, 4 or more of 12, 6 or more of 18, 8 or more of 24, 10 or more of 30 participants experienced target toxicity defined as:
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| Measure | Description | Time Frame |
|---|---|---|
| Median Steady State Trough Concentration of Pegylated Interferon ɑ-2B | The pharmacokinetic (PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed. Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alberto Pappo, MD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rady Children's Hospital | San Diego | California | 92123 | United States | ||
| St. Jude Children's Research Hospital |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
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A total of 29 patients were enrolled between May 9, 2008 and August 22, 2012. Of the 29 participants, 21 were enrolled at St. Jude Children's Research Hospital (SJCRH), 7 at MD Anderson, and 1 at Rady Children's Hospital. Twenty-three participants met stratum A eligibility, 2 met stratum B1 eligibility and 4 met stratum B2 eligibility.
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| ID | Title | Description |
|---|---|---|
| FG000 | Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b | Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Temozolomide | Drug | Given PO. Therapeutic drug class: antineoplastic agent. |
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| Recombinant interferon alfa-2b | Drug | Given IV. Therapeutic drug classes: antineoplastic agent, immunomodulatory agent, interferon |
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| 52 weeks |
| Probability of Event-free Survival (EFS) of Stratum A Participants | The probability of EFS was estimated as time to first event (relapse, death or second malignancy). As of April 2016, 21 out of 23 participants had no events. The EFS rate was estimated by Kaplan-Meier method. | 3 years from diagnosis |
| Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28 |
| Area Under the Curve (AUC) of Pegylated Interferon ɑ-2B | Pharmacokinetic (PK) analysis of pegylated ɑ-2b included only Stratum A patients who had PK studies performed. Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM. AUC is given as Time 0 through infinity. | Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28 |
| ɑ Half Life of Pegylated Interferon ɑ-2B | Pharmacokinetic (PK) analysis of pegylated ɑ-2b included only Stratum A patients who had PK studies performed. Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM. | Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28 |
| Volume of Central Compartment (Vc) of Pegylated Interferon ɑ-2B | Pharmacokinetic (PK) analysis of pegylated ɑ-2b included only Stratum A patients who had PK studies performed. Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM. | Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28 |
| Apparent Clearance (CL) of Pegylated Interferon ɑ-2B | Pharmacokinetic (PK) analysis of pegylated ɑ-2b included only Stratum A patients who had PK studies performed. Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM. | Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28 |
| Area Under the Curve (AUC) of Interferon ɑ-2b | Samples were analyzed for interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM. AUC is given as Time 0 to infinity. | Before first dose, and 1, 2, 4, 6, 8, 12, and 24 hours postinfusion |
| Half-Life of Interferon ɑ-2b | Samples were analyzed for interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM. | Before first dose, and 1, 2, 4, 6, 8, 12, and 24 hours postinfusion |
| Volume of Central Compartment (Vc) of Interferon ɑ-2b | Samples were analyzed for interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM. | Before first dose, and 1, 2, 4, 6, 8, 12, and 24 hours postinfusion |
| Systemic Clearance (CL) of Interferon ɑ-2B | Samples were analyzed for interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM. | Before first dose, and 1, 2, 4, 6, 8, 12, and 24 hours postinfusion |
| Mean Total PedsQL 4.0 Scores for Child Quality of Life (QoL) Assessments (Stratum A) | QoL assessments were completed using Pediatrics Quality of Life Inventory (PedsQL v4.0). Scale range is 0-100 with higher scores reflecting better quality of life. PedsQL 4.0 healthy sample normative mean ± SD for child report = 83.0 ± 14.8. | Pretherapy; Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post |
| Mean Total PedsQL 4.0 Scores for Child Quality of Life (QoL) Assessments (Stratum B) | QoL assessments were completed using Pediatrics Quality of Life Inventory (PedsQL v4.0). Scale range is 0-100 with higher scores reflecting better quality of life. PedsQL 4.0 healthy sample normative mean ± SD for child report = 83.0 ± 14.8. | Pretherapy; Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post |
| Mean Total PedsQL 4.0 Scores for Parent Quality of Life Assessments (Stratum A) | QoL assessments were completed using Pediatrics Quality of Live Inventory (PedsQL v4.0). Scale range is 0-100 with higher scores reflecting better quality of life. PedsQL 4.0 healthy sample normative mean ± SD for parent report = 87.6 ± 12.3. | Pretherapy; Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post |
| Mean Total PedsQL 4.0 Scores for Parent Quality of Life Assessments (Stratum B) | QoL assessments were completed using Pediatrics Quality of Live Inventory (PedsQL v4.0). Scale range is 0-100 with higher scores reflecting better quality of life. PedsQL 4.0 healthy sample normative mean ± SD for parent report = 87.6 ± 12.3. | Pretherapy; Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post |
| Mean Total PedsQL 3.0 Scores for Child Cancer Quality of Life (QoL) Assessments (Stratum A) | QoL assessments were completed using Pediatrics Cancer Quality of Life Inventory (PedsQL v3.0). Scale range is 0-100 with higher scores reflecting better quality of life. | Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post |
| Mean Total PedsQL 3.0 Scores for Child Cancer Quality of Life (QoL) Assessments (Stratum B) | QoL assessments were completed using Pediatrics Cancer Quality of Life Inventory (PedsQL v3.0). Scale range is 0-100 with higher scores reflecting better quality of life. | Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post |
| Mean Total PedsQL 3.0 Scores for Parent Cancer Quality of Life (QoL) Assessments (Stratum A) | QoL assessments were completed using Pediatrics Cancer Quality of Life Inventory (PedsQL v3.0). Scale range is 0-100 with higher scores reflecting better quality of life. | Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post |
| Mean Total PedsQL 3.0 Scores for Parent Cancer Quality of Life (QoL) Assessments (Stratum B) | QoL assessments were completed using Pediatrics Cancer Quality of Life Inventory (PedsQL v3.0). Scale range is 0-100 with higher scores reflecting better quality of life. | Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post |
| BASC-2 Psychological Assessment (Stratum A) | The Behavioral Assessment System for Children, 2nd Edition (BASC-2) was administered to parents, assessing for any effects on behavior or mood in children undergoing study therapy. The behavior system index (BSI) T-score (range 0-100) is reported for the BASC-2 assessment. Higher scores reflect greater behavioral problems. | Pretherapy, Week 4, Week 24, End of Therapy, and 6 Months Post End of Therapy |
| BASC-2 Psychological Assessment (Stratum B) | The Behavioral Assessment System for Children, 2nd Edition (BASC-2) was administered to parents, assessing for any effects on behavior or mood in children undergoing study therapy. The behavior system index (BSI) T-score (range 0-100) is reported for the BASC-2 assessment. Higher scores reflect greater behavioral problems. | Pretherapy, Week 4, Week 24, End of Therapy, and 6 Months Post End of Therapy |
| BRIEF Psychological Assessment (Stratum A) | The Behavioral Rating Inventory of Executive Function (BRIEF) was administered to parents, assessing for any effects on behavior or mood in children undergoing study therapy. The global executive composite (GEC) T-score (range 0-100) is reported for the BRIEF assessment. Higher scores reflect poorer executive function. | Pretherapy, Week 4, Week 24, End of Therapy, and 6 Months Post End of Therapy |
| BRIEF Psychological Assessment (Stratum B) | The Behavioral Rating Inventory of Executive Function (BRIEF) was administered to parents, assessing for any effects on behavior or mood in children undergoing study therapy. The global executive composite (GEC) T-score (range 0-100) is reported for the BRIEF assessment. Higher scores reflect poorer executive function. | Pretherapy, Week 4, Week 24, End of Therapy, and 6 Months Post End of Therapy |
| Memphis |
| Tennessee |
| 38105 |
| United States |
| The Children's Cancer Hospital at UT M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| FG001 |
| Temozolomide/Peginterferon ɑ-2b With Measureable Disease |
Stratum B1: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants with measurable disease Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. |
| FG002 | Temozolomide/Peginterferon ɑ-2b Without Measureable Disease | Stratum B2: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants without measurable disease Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. Stratum B2 (no measurable disease) proceeded with 7 courses as outlined. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b | Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks. |
| BG001 | Temozolomide/Peginterferon ɑ-2b With Measureable Disease | Stratum B1: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants with measurable disease Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. |
| BG002 | Temozolomide/Peginterferon ɑ-2b Without Measureable Disease | Stratum B2: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants without measurable disease Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. Stratum B2 (no measurable disease) proceeded with 7 courses as outlined. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tumor Response Rate | Tumor response rate of stratum B1 participants was evaluated after 1 treatment course of temozolomide plus peginterferon ɑ-2b. Complete response (CR) and partial response (PR) confirmed with repeated scan at least 4 weeks apart following completion of course 1 therapy. CR defined as disappearance of all target and non-target lesions with no new lesions detected. If available, no disease must be detected by immunocytology or serum tumor markers. PR defined as at least 30% decrease in disease measurement compared to disease measurement at study entry with no new lesions detected. Progressive disease (PD) defined as at least 20% increase in the disease measurement compared to the smallest disease measurement recorded since start of treatment, or appearance of one or more new lesions. Stable disease defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD compared to smallest disease measurement since start of treatment. | Posted | Number | participants | 8 weeks |
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| Primary | Number of Patients Who Experience Toxicity at or Above the Target Toxicity for Strata B1 and B2 | The objective was to assess the safety of temozolomide administered in combination with peginterferon a-2b in Stratum B participants. Accrual was suspended any time during therapy if 2 or more of 6, 4 or more of 12, 6 or more of 18, 8 or more of 24, 10 or more of 30 participants experienced target toxicity defined as:
| This toxicity report was based on intention to treat population (ITT), all patients enrolled were included. The study did not meet its accrual goals within the planned timeframe due to slow accrual. | Posted | Number | participants | 52 weeks |
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| Primary | Number of Patients Who Experience Toxicity at or Above the Target Toxicity for Stratum A Patients | The objective was to study the feasibility and safety of administering peginterferon a-2b weekly for 48 weeks following the initial induction phase to Stratum A participants. Accrual was suspended during the 48-week course if 2 or more of 6, 4 or more of 12, 6 or more of 18, 8 or more of 24, 10 or more of 30 participants experienced target toxicity defined as:
| Number of participants for the analysis was based on the intent to treat population, all patients enrolled were included. Participants were enrolled on Stratum A until the accrual goals were met on Stratum B. | Posted | Number | participants | 52 weeks |
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| Primary | Probability of Event-free Survival (EFS) of Stratum A Participants | The probability of EFS was estimated as time to first event (relapse, death or second malignancy). As of April 2016, 21 out of 23 participants had no events. The EFS rate was estimated by Kaplan-Meier method. | Posted | Number | 95% Confidence Interval | probability | 3 years from diagnosis |
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| Other Pre-specified | Median Steady State Trough Concentration of Pegylated Interferon ɑ-2B | The pharmacokinetic (PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed. Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM. | Only one patient had evaluable data in Stratum B and is not included in the final analysis, because data from more than one patient are required for nonlinear-mixed effects modeling. | Posted | Median | Full Range | pcg/ml | Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28 |
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| Other Pre-specified | Area Under the Curve (AUC) of Pegylated Interferon ɑ-2B | Pharmacokinetic (PK) analysis of pegylated ɑ-2b included only Stratum A patients who had PK studies performed. Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM. AUC is given as Time 0 through infinity. | Only one Stratum B patient had evaluable data and is not included in final analysis, because data from more than one patient are required for nonlinear-mixed effects modeling. Two patients in Week 5 and three in Week 28 were excluded due to inadequate sampling to characterize an AUC value. | Posted | Median | Full Range | pcg * hr/ml | Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28 |
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| Other Pre-specified | ɑ Half Life of Pegylated Interferon ɑ-2B | Pharmacokinetic (PK) analysis of pegylated ɑ-2b included only Stratum A patients who had PK studies performed. Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM. | Only one Stratum B patient had evaluable data and is not included in final analysis, because data from more than one patient are required for nonlinear-mixed effects modeling. Two patients in Week 5 and three in Week 28 were excluded due to inadequate sampling to characterize an AUC value. | Posted | Median | Full Range | hours | Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28 |
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| Other Pre-specified | Volume of Central Compartment (Vc) of Pegylated Interferon ɑ-2B | Pharmacokinetic (PK) analysis of pegylated ɑ-2b included only Stratum A patients who had PK studies performed. Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM. | Only one Stratum B patient had evaluable data and is not included in final analysis, because data from more than one patient are required for nonlinear-mixed effects modeling due to differences in clinical variables. Two patients in Week 5 and three in Week 28 were excluded due to inadequate sampling to characterize an AUC value. | Posted | Median | Full Range | ml/kg | Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28 |
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| Other Pre-specified | Apparent Clearance (CL) of Pegylated Interferon ɑ-2B | Pharmacokinetic (PK) analysis of pegylated ɑ-2b included only Stratum A patients who had PK studies performed. Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM. | Only one Stratum B patient had evaluable data and is not included in final analysis due to differences in clinical variables, because data from more than one patient are required for nonlinear-mixed effects modeling. Two patients in Week 5 and three in Week 28 were excluded due to inadequate sampling to characterize an AUC value. | Posted | Median | Full Range | ml/hr/kg | Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28 |
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| Other Pre-specified | Area Under the Curve (AUC) of Interferon ɑ-2b | Samples were analyzed for interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM. AUC is given as Time 0 to infinity. | The pharmacokinetic(PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed. Only one patient had evaluable data in Stratum B and is not included in the final analysis due to differences in clinical variables. | Posted | Median | Full Range | pcg * hr/ml | Before first dose, and 1, 2, 4, 6, 8, 12, and 24 hours postinfusion |
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| Other Pre-specified | Half-Life of Interferon ɑ-2b | Samples were analyzed for interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM. | The pharmacokinetic (PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed. Only one patient had evaluable data in Stratum B and is not included in the final analysis due to differences in clinical variables. | Posted | Median | Full Range | hours | Before first dose, and 1, 2, 4, 6, 8, 12, and 24 hours postinfusion |
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| Other Pre-specified | Volume of Central Compartment (Vc) of Interferon ɑ-2b | Samples were analyzed for interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM. | The pharmacokinetic (PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed. Only one patient had evaluable data in Stratum B and is not included in the final analysis due to differences in clinical variables. | Posted | Median | Full Range | l/m^2 | Before first dose, and 1, 2, 4, 6, 8, 12, and 24 hours postinfusion |
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| Other Pre-specified | Systemic Clearance (CL) of Interferon ɑ-2B | Samples were analyzed for interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM. | The pharmacokinetic (PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed. Only one patient had evaluable data in Stratum B and is not included in the final analysis due to differences in clinical variables. | Posted | Median | Full Range | l/hr/m^2 | Before first dose, and 1, 2, 4, 6, 8, 12, and 24 hours postinfusion |
|
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | Mean Total PedsQL 4.0 Scores for Child Quality of Life (QoL) Assessments (Stratum A) | QoL assessments were completed using Pediatrics Quality of Life Inventory (PedsQL v4.0). Scale range is 0-100 with higher scores reflecting better quality of life. PedsQL 4.0 healthy sample normative mean ± SD for child report = 83.0 ± 14.8. | This QOL analysis included patients only within Stratum A. | Posted | Mean | Standard Deviation | units on a scale | Pretherapy; Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post |
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Mean Total PedsQL 4.0 Scores for Child Quality of Life (QoL) Assessments (Stratum B) | QoL assessments were completed using Pediatrics Quality of Life Inventory (PedsQL v4.0). Scale range is 0-100 with higher scores reflecting better quality of life. PedsQL 4.0 healthy sample normative mean ± SD for child report = 83.0 ± 14.8. | Only one patient had evaluable data in Stratum B. The raw score, rather than the mean +/- SD, is presented. Data was not collected at Week 24, and the patient was taken off study prior to 6 months after end of therapy. | Posted | Number | units on a scale | Pretherapy; Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post |
| |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Mean Total PedsQL 4.0 Scores for Parent Quality of Life Assessments (Stratum A) | QoL assessments were completed using Pediatrics Quality of Live Inventory (PedsQL v4.0). Scale range is 0-100 with higher scores reflecting better quality of life. PedsQL 4.0 healthy sample normative mean ± SD for parent report = 87.6 ± 12.3. | This QOL analysis included patients only within Stratum A. | Posted | Mean | Standard Deviation | units on a scale | Pretherapy; Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post |
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Mean Total PedsQL 4.0 Scores for Parent Quality of Life Assessments (Stratum B) | QoL assessments were completed using Pediatrics Quality of Live Inventory (PedsQL v4.0). Scale range is 0-100 with higher scores reflecting better quality of life. PedsQL 4.0 healthy sample normative mean ± SD for parent report = 87.6 ± 12.3. | Only one patient had evaluable data in Stratum B. The raw score, rather than the mean +/- SD, is presented. Data was not collected after Week 4. | Posted | Number | units on a scale | Pretherapy; Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post |
| |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Mean Total PedsQL 3.0 Scores for Child Cancer Quality of Life (QoL) Assessments (Stratum A) | QoL assessments were completed using Pediatrics Cancer Quality of Life Inventory (PedsQL v3.0). Scale range is 0-100 with higher scores reflecting better quality of life. | PedsQL v3.0 was not completed pretherapy. This QOL analysis included patients only within Stratum A. | Posted | Mean | Standard Deviation | units on a scale | Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post |
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Mean Total PedsQL 3.0 Scores for Child Cancer Quality of Life (QoL) Assessments (Stratum B) | QoL assessments were completed using Pediatrics Cancer Quality of Life Inventory (PedsQL v3.0). Scale range is 0-100 with higher scores reflecting better quality of life. | PedsQL v3.0 was not completed pretherapy. Only one patient had evaluable data in Stratum B. The raw score, rather than the mean +/- SD, is presented. Data was not collected at Week 24, and the patient was taken off study prior to 6 months after end of therapy. | Posted | Number | units on a scale | Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post |
| |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Mean Total PedsQL 3.0 Scores for Parent Cancer Quality of Life (QoL) Assessments (Stratum A) | QoL assessments were completed using Pediatrics Cancer Quality of Life Inventory (PedsQL v3.0). Scale range is 0-100 with higher scores reflecting better quality of life. | PedsQL v3.0 was not completed pretherapy. This QOL analysis included patients only within Stratum A. | Posted | Mean | Standard Deviation | units on a scale | Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post |
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Mean Total PedsQL 3.0 Scores for Parent Cancer Quality of Life (QoL) Assessments (Stratum B) | QoL assessments were completed using Pediatrics Cancer Quality of Life Inventory (PedsQL v3.0). Scale range is 0-100 with higher scores reflecting better quality of life. | PedsQL v3.0 was not completed pretherapy. Only one patient had evaluable data in Stratum B. The raw score, rather than the mean +/- SD, is presented. Data was not collected after Week 4. | Posted | Number | units on a scale | Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post |
| |||||||||||||||||||||||||||||||||||
| Other Pre-specified | BASC-2 Psychological Assessment (Stratum A) | The Behavioral Assessment System for Children, 2nd Edition (BASC-2) was administered to parents, assessing for any effects on behavior or mood in children undergoing study therapy. The behavior system index (BSI) T-score (range 0-100) is reported for the BASC-2 assessment. Higher scores reflect greater behavioral problems. | This QOL analysis included patients only within Stratum A. | Posted | Mean | Standard Deviation | T score | Pretherapy, Week 4, Week 24, End of Therapy, and 6 Months Post End of Therapy |
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | BASC-2 Psychological Assessment (Stratum B) | The Behavioral Assessment System for Children, 2nd Edition (BASC-2) was administered to parents, assessing for any effects on behavior or mood in children undergoing study therapy. The behavior system index (BSI) T-score (range 0-100) is reported for the BASC-2 assessment. Higher scores reflect greater behavioral problems. | Only one patient had evaluable data in Stratum B, but scores were not available for this instrument due to the age of the patient. | Posted | Pretherapy, Week 4, Week 24, End of Therapy, and 6 Months Post End of Therapy |
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | BRIEF Psychological Assessment (Stratum A) | The Behavioral Rating Inventory of Executive Function (BRIEF) was administered to parents, assessing for any effects on behavior or mood in children undergoing study therapy. The global executive composite (GEC) T-score (range 0-100) is reported for the BRIEF assessment. Higher scores reflect poorer executive function. | This QOL analysis included patients only within Stratum A. | Posted | Mean | Standard Deviation | T score | Pretherapy, Week 4, Week 24, End of Therapy, and 6 Months Post End of Therapy |
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | BRIEF Psychological Assessment (Stratum B) | The Behavioral Rating Inventory of Executive Function (BRIEF) was administered to parents, assessing for any effects on behavior or mood in children undergoing study therapy. The global executive composite (GEC) T-score (range 0-100) is reported for the BRIEF assessment. Higher scores reflect poorer executive function. | Only one patient had evaluable data in Stratum B, but scores were not available for this instrument due to the age of the patient. | Posted | Pretherapy, Week 4, Week 24, End of Therapy, and 6 Months Post End of Therapy |
|
Adverse events are reported from the start of treatment for the first patient in May 2008 through April 2016.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b | Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks. | 3 | 23 | 23 | 23 | ||
| EG001 | Temozolomide/Peginterferon ɑ-2b With Measureable Disease | Stratum B1: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants with measurable disease Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. | 0 | 2 | 2 | 2 | ||
| EG002 | Temozolomide/Peginterferon ɑ-2b Without Measureable Disease | Stratum B2: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants without measurable disease Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. Stratum B2 (no measurable disease) proceeded with 7 courses as outlined. | 0 | 4 | 4 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Joint effusion | Musculoskeletal and connective tissue disorders | CTC version 3 | Non-systematic Assessment |
| |
| Confusion | Nervous system disorders | CTC version 3 | Non-systematic Assessment |
| |
| Joint function | Musculoskeletal and connective tissue disorders | CTC version 3 | Non-systematic Assessment |
| |
| Extrapyramidal/involuntary movement/restlessness | Nervous system disorders | CTC version 3 | Non-systematic Assessment |
| |
| Mood alteration, agitation | Nervous system disorders | CTC version 3 | Non-systematic Assessment |
| |
| Psychosis (hallucinations/delusions) | Nervous system disorders | CTC version 3 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | CTC version 3 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | CTC version 3 | Non-systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTC version 3 | Non-systematic Assessment |
| |
| Leukocytes) total WBC) | Blood and lymphatic system disorders | CTC version 3 | Non-systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTC version 3 | Non-systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | CTC version 3 | Non-systematic Assessment |
| |
| Supraventricular and nodal arrhythmia, sinus bradycardia | Cardiac disorders | CTC version 3 | Non-systematic Assessment |
| |
| Supraventricular and nodal arrhythmia, sinus tachycardia | Cardiac disorders | CTC version 3 | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTC version 3 | Non-systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTC version 3 | Non-systematic Assessment |
| |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC<1.0 x 10e9/L) | General disorders | CTC version 3 | Non-systematic Assessment |
| |
| Rigors/chills | General disorders | CTC version 3 | Non-systematic Assessment |
| |
| Sweating (diaphoresis) | General disorders | CTC version 3 | Non-systematic Assessment |
| |
| Weight gain | General disorders | CTC version 3 | Non-systematic Assessment |
| |
| Weight loss | General disorders | CTC version 3 | Non-systematic Assessment |
| |
| Bruising (in absence of Grade 3 or 4 thrombocytopenia) | Skin and subcutaneous tissue disorders | CTC version 3 | Non-systematic Assessment |
| |
| Dermatology/skin - other | Skin and subcutaneous tissue disorders | CTC version 3 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTC version 3 | Non-systematic Assessment |
| |
| Flushing | Skin and subcutaneous tissue disorders | CTC version 3 | Non-systematic Assessment |
| |
| Hair loss/alopecia (scalp or body) | Skin and subcutaneous tissue disorders | CTC version 3 | Non-systematic Assessment |
| |
| Photosensitivity | Skin and subcutaneous tissue disorders | CTC version 3 | Non-systematic Assessment |
| |
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTC version 3 | Non-systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTC version 3 | Non-systematic Assessment |
| |
| Urticaria (hives, welts, wheals) | Skin and subcutaneous tissue disorders | CTC version 3 | Non-systematic Assessment |
| |
| Hot flashes/flushes | Endocrine disorders | CTC version 3 | Non-systematic Assessment |
| |
| Thyroid function, low (hypothyroidism) | Endocrine disorders | CTC version 3 | Non-systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTC version 3 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTC version 3 | Non-systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTC version 3 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTC version 3 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTC version 3 | Non-systematic Assessment |
| |
| Heartburn/dyspepsia | Gastrointestinal disorders | CTC version 3 | Non-systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam), oral cavity | Gastrointestinal disorders | CTC version 3 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTC version 3 | Non-systematic Assessment |
| |
| Taste alteration (dysgeusia) | Gastrointestinal disorders | CTC version 3 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTC version 3 | Non-systematic Assessment |
| |
| Hemorrhage, GI, lower GI NOS | Vascular disorders | CTC version 3 | Non-systematic Assessment |
| |
| Hemorrhage, GI, oral cavity | Vascular disorders | CTC version 3 | Non-systematic Assessment |
| |
| Hemorrhage, GI, rectum | Vascular disorders | CTC version 3 | Non-systematic Assessment |
| |
| Hemorrhage, GI, upper GI NOS | Vascular disorders | CTC version 3 | Non-systematic Assessment |
| |
| Hemorrhage, pulmonary/upper respiratory, nose | Vascular disorders | CTC version 3 | Non-systematic Assessment |
| |
| Hemorrhage/bleeding - other | Vascular disorders | CTC version 3 | Non-systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils, lip/perioral | Infections and infestations | CTC version 3 | Non-systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils, middle ear (otitis media) | Infections and infestations | CTC version 3 | Non-systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils, nerve-peripheral | Infections and infestations | CTC version 3 | Non-systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils, sinus | Infections and infestations | CTC version 3 | Non-systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils, upper airway NOS | Infections and infestations | CTC version 3 | Non-systematic Assessment |
| |
| Infection with unknown ANC, sinus | Infections and infestations | CTC version 3 | Non-systematic Assessment |
| |
| Edema: head and neck | Blood and lymphatic system disorders | CTC version 3 | Non-systematic Assessment |
| |
| Edema: limb | Blood and lymphatic system disorders | CTC version 3 | Non-systematic Assessment |
| |
| Edema: trunk/genital | Blood and lymphatic system disorders | CTC version 3 | Non-systematic Assessment |
| |
| Lymphatics - other | Blood and lymphatic system disorders | CTC version 3 | Non-systematic Assessment |
| |
| ALT, SGPT (serum gluatmic pyruvic transaminase) | Metabolism and nutrition disorders | CTC version 3 | Non-systematic Assessment |
| |
| AST, SGOT (serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | CTC version 3 | Non-systematic Assessment |
| |
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTC version 3 | Non-systematic Assessment |
| |
| Alkaline phosphatase | Metabolism and nutrition disorders | CTC version 3 | Non-systematic Assessment |
| |
| Amylase | Metabolism and nutrition disorders | CTC version 3 | Non-systematic Assessment |
| |
| Calcium, serum-high (hypercalcemia) | Metabolism and nutrition disorders | CTC version 3 | Non-systematic Assessment |
| |
| Calcium, serum-low (hypocalcemia | Metabolism and nutrition disorders | CTC version 3 | Non-systematic Assessment |
| |
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTC version 3 | Non-systematic Assessment |
| |
| Glucose, serum-low (hypoglycemia) | Metabolism and nutrition disorders | CTC version 3 | Non-systematic Assessment |
| |
| Lipase | Metabolism and nutrition disorders | CTC version 3 | Non-systematic Assessment |
| |
| Magnesium, serum-high (hypermagnesemia) | Metabolism and nutrition disorders | CTC version 3 | Non-systematic Assessment |
| |
| Magnesium, serum-low (hypomagnesemia) | Metabolism and nutrition disorders | CTC version 3 | Non-systematic Assessment |
| |
| Metabolic/laboratory - other | Metabolism and nutrition disorders | CTC version 3 | Non-systematic Assessment |
| |
| Potassium, serum-high (hyperkalemia | Metabolism and nutrition disorders | CTC version 3 | Non-systematic Assessment |
| |
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTC version 3 | Non-systematic Assessment |
| |
| Proteinuria | Metabolism and nutrition disorders | CTC version 3 | Non-systematic Assessment |
| |
| Sodium, serum-high (hypernatremia) | Metabolism and nutrition disorders | CTC version 3 | Non-systematic Assessment |
| |
| Triglyceride, serum-high (hypertriglyceridemia) | Metabolism and nutrition disorders | CTC version 3 | Non-systematic Assessment |
| |
| Uric acid, serum-high (hyperuricemia) | Metabolism and nutrition disorders | CTC version 3 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTC version 3 | Non-systematic Assessment |
| |
| Mood alteration, agitation | Nervous system disorders | CTC version 3 | Non-systematic Assessment |
| |
| Mood alteration, anxiety | Nervous system disorders | CTC version 3 | Non-systematic Assessment |
| |
| Mood alteration, depression | Nervous system disorders | CTC version 3 | Non-systematic Assessment |
| |
| Neuropathy: sensory | Nervous system disorders | CTC version 3 | Non-systematic Assessment |
| |
| Personality/behavioral | Nervous system disorders | CTC version 3 | Non-systematic Assessment |
| |
| Ocular surface disease | Eye disorders | CTC version 3 | Non-systematic Assessment |
| |
| Ocular/visual - other | Eye disorders | CTC version 3 | Non-systematic Assessment |
| |
| Vision-blurred vision | Eye disorders | CTC version 3 | Non-systematic Assessment |
| |
| Bronchospasm, wheezing | Respiratory, thoracic and mediastinal disorders | CTC version 3 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTC version 3 | Non-systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTC version 3 | Non-systematic Assessment |
| |
| Incontinence, urinary | Renal and urinary disorders | CTC version 3 | Non-systematic Assessment |
| |
| Urinary frequency/urgency | Renal and urinary disorders | CTC version 3 | Non-systematic Assessment |
| |
| Irregular menses (change from baseline) | Reproductive system and breast disorders | CTC version 3 | Non-systematic Assessment |
| |
| Pain, abdomen NOS | General disorders | CTC version 3 | Non-systematic Assessment |
| |
| Pain, back | General disorders | CTC version 3 | Non-systematic Assessment |
| |
| Pain, chest wall | General disorders | CTC version 3 | Non-systematic Assessment |
| |
| Pain, chest/thorax NOS | General disorders | CTC version 3 | Non-systematic Assessment |
| |
| Pain, dental/teeth/peridontal | General disorders | CTC version 3 | Non-systematic Assessment |
| |
| Pain, external ear | General disorders | CTC version 3 | Non-systematic Assessment |
| |
| Pain, extremity-limb | General disorders | CTC version 3 | Non-systematic Assessment |
| |
| Pain, head/headache | General disorders | CTC version 3 | Non-systematic Assessment |
| |
| Pain, joint | General disorders | CTC version 3 | Non-systematic Assessment |
| |
| Pain, muscle | General disorders | CTC version 3 | Non-systematic Assessment |
| |
| Pain, neck | General disorders | CTC version 3 | Non-systematic Assessment |
| |
| Pain, pain NOS | General disorders | CTC version 3 | Non-systematic Assessment |
| |
| Pain, stomach | General disorders | CTC version 3 | Non-systematic Assessment |
| |
| Pain, throat/pharynx/larynx | General disorders | CTC version 3 | Non-systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils, Lung (pnemonia) | Infections and infestations | CTC version 3 | Non-systematic Assessment |
| |
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | CTC version 3 | Non-systematic Assessment |
|
The study closed early due to poor accrual to stratum B1.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alberto Pappo, MD | St. Jude Children's Research Hospital | 901-595-2322 | info@stjude.org |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C417083 | peginterferon alfa-2b |
| D000077204 | Temozolomide |
| D007438 | Introns |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D021901 | DNA, Intergenic |
| D040481 | Genome Components |
| D016678 | Genome |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |
| D040461 | Gene Components |
| D005796 | Genes |
Not provided
Not provided
| Male |
|
| OG001 | Temozolomide/Peginterferon ɑ-2b Without Measureable Disease | Stratum B2: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants without measurable disease Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. Stratum B2 (no measurable disease) proceeded with 7 courses as outlined. |
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
|
QoL assessment completed at Week 12. |
| OG005 | Week 24 | QoL assessment completed at Week 24. |
| OG006 | End of Therapy | QoL assessment completed at end of therapy. |
| OG007 | 6 Months After End of Therapy | QoL assessment completed 6 months after end of therapy. |
| OG008 | 12 Months After End of Therapy | QoL assessment completed 12 months after end of therapy. |
|
|
| OG004 | Week 12 | QoL assessment completed at Week 12. |
| OG005 | Week 24 | QoL assessment completed at Week 24. |
| OG006 | End of Therapy | QoL assessment completed at end of therapy. |
| OG007 | 6 Months After End of Therapy | QoL assessment completed 6 months after end of therapy. |
| OG008 | 12 Months After End of Therapy | QoL assessment completed 12 months after end of therapy. |
|
|
QoL assessment completed at Week 12. |
| OG005 | Week 24 | QoL assessment completed at Week 24. |
| OG006 | End of Therapy | QoL assessment completed at end of therapy. |
| OG007 | 6 Months After End of Therapy | QoL assessment completed 6 months after end of therapy. |
| OG008 | 12 Months After End of Therapy | QoL assessment completed 12 months after end of therapy. |
|
|
| OG004 |
| Week 12 |
QoL assessment completed at Week 12. |
| OG005 | Week 24 | QoL assessment completed at Week 24. |
| OG006 | End of Therapy | QoL assessment completed at end of therapy. |
| OG007 | 6 Months After End of Therapy | QoL assessment completed 6 months after end of therapy. |
| OG008 | 12 Months After End of Therapy | QoL assessment completed 12 months after end of therapy. |
|
|
QoL assessment completed at Week 24. |
| OG005 | End of Therapy | QoL assessment completed at end of therapy. |
| OG006 | 6 Months After End of Therapy | QoL assessment completed 6 months after end of therapy. |
| OG007 | 12 Months After End of Therapy | QoL assessment completed 12 months after end of therapy. |
|
|
| OG004 |
| Week 24 |
QoL assessment completed at Week 24. |
| OG005 | End of Therapy | QoL assessment completed at end of therapy. |
| OG006 | 6 Months After End of Therapy | QoL assessment completed 6 months after end of therapy. |
| OG007 | 12 Months After End of Therapy | QoL assessment completed 12 months after end of therapy. |
|
|
QoL assessment completed at Week 24. |
| OG005 | End of Therapy | QoL assessment completed at end of therapy. |
| OG006 | 6 Months After End of Therapy | QoL assessment completed 6 months after end of therapy. |
| OG007 | 12 Months After End of Therapy | QoL assessment completed 12 months after end of therapy. |
|
|
| Week 24 |
QoL assessment completed at Week 24. |
| OG005 | End of Therapy | QoL assessment completed at end of therapy. |
| OG006 | 6 Months After End of Therapy | QoL assessment completed 6 months after end of therapy. |
| OG007 | 12 Months After End of Therapy | QoL assessment completed 12 months after end of therapy. |
|
|
| OG004 |
| 6 Months After End of Therapy |
QoL assessment completed 6 months after end of therapy. |
|
|
| OG004 |
| 6 Months After End of Therapy |
QoL assessment completed 6 months after end of therapy. |
|
| OG004 |
| 6 Months After End of Therapy |
QoL assessment completed 6 months after end of therapy. |
|
|
| OG004 |
| 6 Months After End of Therapy |
QoL assessment completed 6 months after end of therapy. |
|