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| Name | Class |
|---|---|
| Children's Healthcare of Atlanta | OTHER |
| Dana-Farber Cancer Institute | OTHER |
| M.D. Anderson Cancer Center | OTHER |
| Phoenix Children's Hospital |
Standard treatment for patients with diffuse pontine tumors is radiation therapy, but less than 10% of patients are cured. Adding standard chemotherapy has not improved the cure rate.
Standard treatment for high-grade astrocytomas is surgery and radiation. The surgeon removes as much of the tumor as she or he can. Radiation after that tries to kill any cancer cells that are left. Some patients also get chemotherapy. These are anti-cancer drugs. They can be given during or after radiation. Current standard treatments do not cure many patients.
In this study the doctors are adding a new medication called cetuximab to the treatment and will also use a chemotherapy medication (irinotecan) that has been promising for patients treated for recurrent disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pts with high-grade astrocytoma | Experimental | This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash. |
|
| pts with diffuse pontine tumor | Experimental | This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan | Other | External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With High-grade Astrocytoma and Diffuse Pontine Tumors Achieving One Year Progression Free Survival. | 1 year | |
| Number of Participants Experiencing Toxicity | To determine the safety of cetuximab administered weekly in conjunction with involved field external beam radiation therapy for diffuse pontine tumors and high-grade astrocytomas, toxicities will be assessed via the NCI Common Terminology Criteria for Adverse Events (CTCAE, version 3.0) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression | 2 years | |
| Number of Participants Who Have Undergone Tumor Analysis | Participant tumor analysis for potential associations between primary tumor tissue molecular markers and tumor response. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Ira Dunkel, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children'S Hospital | Phoenix | Arizona | 85016 | United States | ||
| University of Colorado Health Sciences Center |
Not provided
| Label | URL |
|---|---|
| Memorial Sloan-Kettering Cancer Center | View source |
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Pts With High-grade Astrocytoma | This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash. cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 10, 2012 |
Not provided
| OTHER |
| Alberta Children's Hospital | OTHER |
| University of Colorado, Denver | OTHER |
| Seattle Children's Hospital | OTHER |
| Johns Hopkins University | OTHER |
| Children's Mercy Hospital Kansas City | OTHER |
| University of Florida | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 2 years |
| Number of Samples Demonstrating EGFR Copy Number Gain | Identify gene transcripts for putative cetuximab | 2 years |
| Number of Participant Tumors Analyzed for Potential Association Between Histology (Grade) With Protein and ELISA Measurements of Those Proteins. | 2 years |
| Percentage of Participants With Development of Rash, Either Acneiform and/or Desquamation | The purpose is to investigate whether the rash associated with cetuximab is secondary to an inflammatory pathway initiated and mediated by the action of cetuximab on host cells. | 2 years |
| Event Free Survival | up to 12 months |
| Overall Survival | Up to 43 months |
| Denver |
| Colorado |
| United States |
| University of Florida | Gainesville | Florida | United States |
| MD Anderson Cancer Center Orlando at Arnold Palmer Hospital for Children | Orlando | Florida | 32806 | United States |
| Children's Healthcare of Atlanta at Egleston | Atlanta | Georgia | 30322 | United States |
| John Hopkins Medical Center | Baltimore | Maryland | 21287 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Children's Mercy Hospital & Clinics | Kansas City | Missouri | 64108 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Md Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Seattle Children'S Hospital | Seattle | Washington | United States |
| Alberta Children'S Hospital | Calgary | Alberta | T2N 1N4 | Canada |
| FG001 | Pts With Diffuse Pontine Tumor | This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash. cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pts With High-grade Astrocytoma | This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash. cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week. |
| BG001 | Pts With Diffuse Pontine Tumor | This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash. cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 Participants With High-grade Astrocytoma and Diffuse Pontine Tumors Achieving One Year Progression Free Survival. | Posted | Count of Participants | Participants | 1 year |
|
|
| |||||||||||||||||||||||||||||||
| Primary | Number of Participants Experiencing Toxicity | To determine the safety of cetuximab administered weekly in conjunction with involved field external beam radiation therapy for diffuse pontine tumors and high-grade astrocytomas, toxicities will be assessed via the NCI Common Terminology Criteria for Adverse Events (CTCAE, version 3.0) | Posted | Count of Participants | Participants | 2 years |
| ||||||||||||||||||||||||||||||||
| Secondary | Time to Progression | Posted | Median | 95% Confidence Interval | months | 2 years |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Have Undergone Tumor Analysis | Participant tumor analysis for potential associations between primary tumor tissue molecular markers and tumor response. | Posted | Count of Participants | Participants | 2 years |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Samples Demonstrating EGFR Copy Number Gain | Identify gene transcripts for putative cetuximab | Paraffin-embedded tumor sections were obtained from 19 of 23 patients who underwent surgery (18 HGA and one DIPG). Because only 1 DIPG sample was available and based on the number of available samples per arm it was pre-specified to pool data for this Outcome Measure. | Posted | Number | samples | 2 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participant Tumors Analyzed for Potential Association Between Histology (Grade) With Protein and ELISA Measurements of Those Proteins. | Posted | Count of Participants | Participants | 2 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Development of Rash, Either Acneiform and/or Desquamation | The purpose is to investigate whether the rash associated with cetuximab is secondary to an inflammatory pathway initiated and mediated by the action of cetuximab on host cells. | Posted | Number | percentage of participants | 2 years |
| ||||||||||||||||||||||||||||||||
| Secondary | Event Free Survival | Posted | Median | 95% Confidence Interval | months | up to 12 months |
| ||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Posted | Median | 95% Confidence Interval | months | Up to 43 months |
|
Up to 43 months
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 | Pts With High-grade Astrocytoma | This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash. cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week. | 16 | 21 | 16 | 21 | 21 | 21 |
| EG001 | Pts With Diffuse Pontine Tumor | This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash. cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week. | 24 | 26 | 17 | 26 | 26 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ataxia (incoordination) | Nervous system disorders | Systematic Assessment |
| ||
| CNS necrosis/cystic progression | Nervous system disorders | Systematic Assessment |
| ||
| Colitis, infectious | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Death not assoc w CTCAE term-Disease prog NOS | General disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphagia (Difficulty swallowing) | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Extrpyrmdl/invlntry mvmnt/rstlssnss | Nervous system disorders | Systematic Assessment |
| ||
| Hemorrhage, CNS | Nervous system disorders | Systematic Assessment |
| ||
| Hydrocephalus | Nervous system disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Inf norm ANC/gr1/2 neut-Blood | Infections and infestations | Systematic Assessment |
| ||
| Inf norm ANC/gr1/2 neut-Cellulitis(skin) | Infections and infestations | Systematic Assessment |
| ||
| Inf unknown ANC-Blood | Infections and infestations | Systematic Assessment |
| ||
| Inf unknown ANC-Pneumonia(lung) | Infections and infestations | Systematic Assessment |
| ||
| Infection, other | Infections and infestations | Systematic Assessment |
| ||
| Intra-operat injury- Brain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Keratitis (corneal inflamm/ulceratn) | Eye disorders | Systematic Assessment |
| ||
| Leak, cerebrospinal fluid (CSF) | Nervous system disorders | Systematic Assessment |
| ||
| Lymphopenia | Investigations | Systematic Assessment |
| ||
| Mood alteration - Agitation | Psychiatric disorders | Systematic Assessment |
| ||
| Mucositis (Clin exam)- Oral cavity | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Neurology - Other (specify) | Nervous system disorders | Systematic Assessment |
| ||
| Neuropathy: cranial - CN II Vision | Nervous system disorders | Systematic Assessment |
| ||
| Neuropathy: motor | Nervous system disorders | Systematic Assessment |
| ||
| Nrpthy:cranl-CN IX Mtr-phrynx;snsry-ear,phrynx,tng | Nervous system disorders | Systematic Assessment |
| ||
| Nrpthy:cranl-CN X Mtr-palate;phrynx,lrynx | Nervous system disorders | Systematic Assessment |
| ||
| Pain - Abdomen NOS | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pain - Head/headache | Nervous system disorders | Systematic Assessment |
| ||
| Pain - Pain NOS | General disorders | Systematic Assessment |
| ||
| Personality/behavioral | Psychiatric disorders | Systematic Assessment |
| ||
| Potassium, low (hypokalemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Pulm/upp respiratory - Other (spec) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rash/desquamation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Renal/Genitourinary-Other Specify | Renal and urinary disorders | Systematic Assessment |
| ||
| Seizure | Nervous system disorders | Systematic Assessment |
| ||
| Sodium, low (hyponatremia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Somnolence/dprssd level of conscious | Nervous system disorders | Systematic Assessment |
| ||
| Speech impairment | Nervous system disorders | Systematic Assessment |
| ||
| Thrombosis/thrombus/embolism | Vascular disorders | Systematic Assessment |
| ||
| Urinary retention (includ neurogenic bladder) | Renal and urinary disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Weight loss | Investigations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Albumin, low (hypoalbuminemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Allerg react/hypersens (incl drug fever) | Immune system disorders | Systematic Assessment |
| ||
| ALT, SGPT | Investigations | Systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| AST, SGOT | Investigations | Systematic Assessment |
| ||
| Ataxia (incoordination) | Nervous system disorders | Systematic Assessment |
| ||
| Auditory/Ear, other | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Bicarbonate, serum-low | Investigations | Systematic Assessment |
| ||
| Calcium, low (hypocalcemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Cushingoid appearance | Endocrine disorders | Systematic Assessment |
| ||
| Death not assoc w CTCAE term-Disease prog NOS | General disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dermatology/Skin, other | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Distension/bloating, abdominal | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dysphagia (Difficulty swallowing) | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Fatigue (asthenia, lethargy, malaise) | General disorders | Systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Fever (in the absence of neutropenia) | General disorders | Systematic Assessment |
| ||
| Glucose, high (hyperglycemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Glucose, low (hypoglycemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hearing:pts w/o BL audiogm & not enroll in mon prg | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Hemoglobin | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hydrocephalus | Nervous system disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Incontinence, urinary | Renal and urinary disorders | Systematic Assessment |
| ||
| Inf norm ANC/gr1/2 neut-Mucosa | Infections and infestations | Systematic Assessment |
| ||
| Inf norm ANC/gr1/2 neut-Myositis infection(muscle) | Infections and infestations | Systematic Assessment |
| ||
| Inf norm ANC/gr1/2 neut-Otitis externa | Infections and infestations | Systematic Assessment |
| ||
| Inf unknown ANC-Cellulitis(skin) | Infections and infestations | Systematic Assessment |
| ||
| Infection, other | Infections and infestations | Systematic Assessment |
| ||
| Intra-op injury- CN VII (facial) motor-face | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Keratitis (corneal inflamm/ulceratn) | Eye disorders | Systematic Assessment |
| ||
| Leak, cerebrospinal fluid (CSF) | Nervous system disorders | Systematic Assessment |
| ||
| Leukocytes (total WBC) | Investigations | Systematic Assessment |
| ||
| Lymphopenia | Investigations | Systematic Assessment |
| ||
| Magnesium, low (hypomagnesemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Memory impairment | Nervous system disorders | Systematic Assessment |
| ||
| Mood alteration - Agitation | Psychiatric disorders | Systematic Assessment |
| ||
| Mood alteration - Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Muscle weakness - Left-sided | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscle weakness - Right-sided | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Neurology - Other (specify) | Nervous system disorders | Systematic Assessment |
| ||
| Neuropathy: motor | Nervous system disorders | Systematic Assessment |
| ||
| Neutrophils/granulocytes (ANC/AGC) | Investigations | Systematic Assessment |
| ||
| Nrpthy:cranl-CN III Pupl,upp eyeld, extrclr mvmnts | Nervous system disorders | Systematic Assessment |
| ||
| Nrpthy:cranl-CN IV Dwnwrd,inwrd eye mvmnt | Nervous system disorders | Systematic Assessment |
| ||
| Nrpthy:cranl-CN IX Mtr-phrynx;snsry-ear,phrynx,tng | Nervous system disorders | Systematic Assessment |
| ||
| Nrpthy:cranl-CN VI Ltrl eye dviatn | Nervous system disorders | Systematic Assessment |
| ||
| Nrpthy:cranl-CN VII Mtr-face;snsry-taste | Nervous system disorders | Systematic Assessment |
| ||
| Nrpthy:cranl-CN VIII Hearing,balance | Nervous system disorders | Systematic Assessment |
| ||
| Nrpthy:cranl-CN X Mtr-palate;phrynx,lrynx | Nervous system disorders | Systematic Assessment |
| ||
| Nrpthy:cranl-CN XI Mtr-strnmstd,trpzius | Nervous system disorders | Systematic Assessment |
| ||
| Nrpthy:cranl-CN XII Motor-tongue | Nervous system disorders | Systematic Assessment |
| ||
| Obesity | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Ocular surface disease | Eye disorders | Systematic Assessment |
| ||
| Ophthalmoplegia/diplopia (double vision) | Eye disorders | Systematic Assessment |
| ||
| Otitis, external ear (non-infect) | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Pain - Abdomen NOS | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pain - Head/headache | Nervous system disorders | Systematic Assessment |
| ||
| Phosphate, low (hypophosphatemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Platelets | Investigations | Systematic Assessment |
| ||
| Potassium, low (hypokalemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Potassium, low (hypokalemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Pruritus/itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pulm/upp respiratory - Other (spec) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pyramidal tract dysfunction | Nervous system disorders | Systematic Assessment |
| ||
| Rash/desquamation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash: erythema multiforme | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Seizure | Nervous system disorders | Systematic Assessment |
| ||
| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Sodium, high (hypernatremia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Sodium, low (hyponatremia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Somnolence/dprssd level of conscious | Nervous system disorders | Systematic Assessment |
| ||
| Speech impairment | Nervous system disorders | Systematic Assessment |
| ||
| Supraventricular arrhythmia NOS | Cardiac disorders | Systematic Assessment |
| ||
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Vision-blurred vision | Eye disorders | Systematic Assessment |
| ||
| Voice changes/dysarthria | Nervous system disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Weight gain | Investigations | Systematic Assessment |
| ||
| Weight loss | Investigations | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ira Dunkel, MD | Memorial Sloan Kettering Cancer Center | 212-639-2153 | dunkeli@mskcc.org |
| Oct 5, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
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