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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA060553 | U.S. NIH Grant/Contract | View source | |
| NU 07H4 | Other Identifier | Northwestern University | |
| SPRI-NU-07H4 | |||
| STU00002993 | Other Identifier | Northwestern University IRB |
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Closed early due to poor accrual.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: PEG-interferon alfa-2b may interfere with the growth of cancer cells and slow the growth of mycosis fungoides/Sezary syndrome. Ultraviolet light therapy uses a drug, such as psoralen, that is absorbed by cancer cells. The drug becomes active when it is exposed to ultraviolet light. When the drug is active, cancer cells are killed. Giving PEG-interferon alfa-2b together with ultraviolet light therapy may kill more cancer cell.
PURPOSE: This is a pilot study of dose-escalating pegylated IFN-α-2b and PUVA or NB-UVB. The purpose is to study the side effects and best dose of PEG-interferon alfa-2b to be given together with ultraviolet light therapy in patients with stage IB, stage II, stage III, or stage IVA mycosis fungoides/Sezary syndrome (CTCL).
Patients receive PEG-interferon alfa-2b subcutaneously once weekly for 12 months in the absence of disease progression or unacceptable toxicity. Patients also receive UV light therapy (either PUVA or NB-UVB).
Health-related quality of life is assessed periodically using the FACT-BRM, FACT-G, and FACT-CTCL questionnaires.
After completion of study therapy, patients are followed for 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-IFN-α-2b + UV therapy | Experimental | Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated interferon α-2b | Biological | PEG-IFN-α-2b will be administered subcutaneously once a week. The starting dose of PEG-IFN-α-2b will be 1.5μg/kg. Each patient will undergo dose escalation to 3, 4.5, 6, 7.5, and up to 9μg/kg every 2 weeks or to maximum tolerated dose will be allowed. If no dose limiting toxicity (DLT) is observed, the maximum dose reached will be expanded. Once this dose has been given weekly for 2 weeks with no DLT, therapy will continue at this dose for up to 1 year depending on response. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Dose Limiting Toxicities (DLTs) Observed During Dose Escalation of PEG-IFN-α-2b | Adverse events are graded according to the National Cancer Institute's Common Toxicity Criteria (CTCAE) version 3.0. In general, grades are assigned as follows: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE A dose limiting toxicity (DLT) will be defined as any grade 3 or higher hematologic toxicity or any grade 4 non-hematologic toxicity. | From the date that the first patient began treatment until the last patient completed the dose escalation phase (up to 12 weeks per patient) |
| Change in Total Health-related Quality of Life Score Using the Functional Assessment of Cancer Therapy - Biologic Response Modifier (FACT-BRM) | The FACT-BRM is a patient self-report tool to assess health-related quality of life measures. | During 12 weeks of dose escalation and then up to one year during maintenance therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Exhibiting a Complete Response | Response was assessed according to the Composite Assessment of Index Lesion Disease Severity. Clinical signs are graded on scales of 0 to 8 (0 being no evidence of disease and 8 being the near worst severity of sign/symptom). The CA response is calculated as the ratio of the sum of the grades for all clinical signs plus the surface areas for all index lesions at each visit compared to the sum of these grades at baseline. The CA also considers all other cutaneous lesions and any extra-cutaneous manifestations of disease. CR requires a CA ratio of 0 (zero) with no evidence of new disease (abnormal or pathologically positive lymph nodes, cutaneous or other tumor manifestations, visceral disease) present over 4 weeks. Patients with Sézary Syndrome must have no evidence of circulating Sézary cells (< 5% Sézary cells are considered to be not significant). Skin biopsy is required for documentation of CR. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Activation Status of Key Signaling Molecules Between Baseline and After 2 Weeks of Treatment | The activation status of key signaling molecules affecting the PI3K and JAK/STAT pathways was to be analyzed in samples of skin and blood taken at baseline and after 2 weeks of treatment. Participation in this exploratory component of the trial was optional for patients. | At baseline and after 2 weeks of treatment (for those patients who consented to this portion) |
DISEASE CHARACTERISTICS:
Histologically confirmed mycosis fungoides/Sezary syndrome
Measurable disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy M. Kuzel, MD | Robert H. Lurie Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611-3013 | United States |
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Study opened at Northwestern University in 09/2008 with an accrual goal of 15 subjects. The study was suspended from 11/2009 to 07/2010 due to a shortage of psoralens; a revision allowed the use of PUVA or NB-UVB for UV therapy.
A total of 7 patients were enrolled before the study was closed due to poor accrual in 05/2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | PEG-IFN-alpha-2b + UV Therapy | Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dose Escalation Phase |
|
| |||||||||||||||||||||
| Maintenance Therapy |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PEG-IFN-alpha-2b + UV Therapy | Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Number of Dose Limiting Toxicities (DLTs) Observed During Dose Escalation of PEG-IFN-α-2b | Adverse events are graded according to the National Cancer Institute's Common Toxicity Criteria (CTCAE) version 3.0. In general, grades are assigned as follows: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE A dose limiting toxicity (DLT) will be defined as any grade 3 or higher hematologic toxicity or any grade 4 non-hematologic toxicity. | Posted | Number | dose limiting toxicities | From the date that the first patient began treatment until the last patient completed the dose escalation phase (up to 12 weeks per patient) |
|
Adverse events were reported from the date the first patient began treatment until 30 days after the last patient went off study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PEG-IFN-alpha-2b + UV Therapy | Pegylated interferon α-2b in combination with UV therapy (either PUVA or NB-UVB). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction/extravasation changes | Skin and subcutaneous tissue disorders | CTCAE v 3.0 | Systematic Assessment | Pain and/or swelling with inflammation or phlebitis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT, SGPT elevation | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
Only 7 patients were enrolled before the study was terminated by the Data Monitoring Committee due to poor accrual. Accrual was limited by a worldwide psoralen shortage and well as the exclusion of patients with prior UV light exposure.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Timothy Kuzel | Northwestern University | 312-695-6180 | cancertrials@northwestern.edu |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C417083 | peginterferon alfa-2b |
| D011564 | Furocoumarins |
| ID | Term |
|---|---|
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
|
| Psoralens with ultraviolet light A | Other | Oral psoralen (8-methoxypsoralen, 0.6-1.0 mg/kg) will be taken 1.5 to 2 hours prior to UVA treatment. The initial UVA dosage will be approximately 0.5 to 1.5 J/cm2, and will be increased in increments as determined by skin type and tolerability. PUVA therapy will be given 2-3 times per week until complete remission (CR) is achieved. Afterwards, additional maintenance therapy will be given with a gradual reduction from once a week to every 4-6 weeks up to 1 year after CR was achieved. |
|
|
| Narrowband-ultraviolet light B | Other | The initial NB-UVB dose will be 70% of the patient's MED and approximately 0.2 J/cm2 and will be increased by 15% of each subsequent treatment as determined by skin type and/or tolerability. Therapy will be given 3 times per week until complete remission (CR) is achieved. Additional maintenance therapy will be administered while gradually reducing NB-UVB from thrice weekly to once a week. All patients will continue maintenance NB-UVB therapy until 1 year after they have achieved CR. |
|
|
| During 12 weeks of dose escalation and then up to one year during maintenance therapy. |
| To Evaluate the Duration of Response | To evaluate duration of response related to combined pegylated IFN-α-2b plus PUVA or NB-UVB therapy. | At each study visit |
| Correlation of Response With Infiltration of Skin Lesions With Dendritic Cells, Cytotoxic CD8+ T-cells, and NK-cells | Baseline, 24 hours post-1st dose in the dose escalation phase, and 24 hours post-1st dose in the maintenance therapy phase |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Change in Total Health-related Quality of Life Score Using the Functional Assessment of Cancer Therapy - Biologic Response Modifier (FACT-BRM) | The FACT-BRM is a patient self-report tool to assess health-related quality of life measures. | No data collected for this outcome measure. | Posted | During 12 weeks of dose escalation and then up to one year during maintenance therapy. |
|
|
| Secondary | Number of Patients Exhibiting a Complete Response | Response was assessed according to the Composite Assessment of Index Lesion Disease Severity. Clinical signs are graded on scales of 0 to 8 (0 being no evidence of disease and 8 being the near worst severity of sign/symptom). The CA response is calculated as the ratio of the sum of the grades for all clinical signs plus the surface areas for all index lesions at each visit compared to the sum of these grades at baseline. The CA also considers all other cutaneous lesions and any extra-cutaneous manifestations of disease. CR requires a CA ratio of 0 (zero) with no evidence of new disease (abnormal or pathologically positive lymph nodes, cutaneous or other tumor manifestations, visceral disease) present over 4 weeks. Patients with Sézary Syndrome must have no evidence of circulating Sézary cells (< 5% Sézary cells are considered to be not significant). Skin biopsy is required for documentation of CR. | No data collected for this outcome measure. | Posted | During 12 weeks of dose escalation and then up to one year during maintenance therapy. |
|
|
| Secondary | To Evaluate the Duration of Response | To evaluate duration of response related to combined pegylated IFN-α-2b plus PUVA or NB-UVB therapy. | No data collected for this outcome measure. | Posted | At each study visit |
|
|
| Other Pre-specified | Change in Activation Status of Key Signaling Molecules Between Baseline and After 2 Weeks of Treatment | The activation status of key signaling molecules affecting the PI3K and JAK/STAT pathways was to be analyzed in samples of skin and blood taken at baseline and after 2 weeks of treatment. Participation in this exploratory component of the trial was optional for patients. | Not Posted | At baseline and after 2 weeks of treatment (for those patients who consented to this portion) | Participants |
| Other Pre-specified | Correlation of Response With Infiltration of Skin Lesions With Dendritic Cells, Cytotoxic CD8+ T-cells, and NK-cells | Not Posted | Baseline, 24 hours post-1st dose in the dose escalation phase, and 24 hours post-1st dose in the maintenance therapy phase | Participants |
| 2 |
| 7 |
| 7 |
| 7 |
|
| Ventricular arrhythmia - ventricular tachycardia | Cardiac disorders | CTCAE v 3.0 | Systematic Assessment |
|
| AST, SGOT elevation | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Burn | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constitutional symptoms - other (fever, chills, sweats, aches & pains) | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Creatinine - elevation | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemoglobin (decrease) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypopigmentation - slight or localized | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection - skin (cellulitis) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Insomnia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leukocytes (total WBC) - decreased | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Musculoskeletal/soft tissue - other (injection site pain) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutrophils/granulocytes (ANC/AGC) - decreased | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Odor (patient) | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Other impact on blood/bone marrow | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - head/headache | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - muskuloskeletal | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Platelets (decreased) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Potassium, serum-high (hyperkalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pruritus/itching - mild or localized | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rigors/chills | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Weight loss - intervention not indicated | General disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D006571 |
| Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |