Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed, Non-metastatic Desmoplastic Medulloblastoma
Completed · Phase 2
Conditions studied: Desmoplastic/Nodular Medulloblastoma, Medulloblastoma, Medulloblastoma With Extensive Nodularity, Nevoid Basal Cell Carcinoma Syndrome
In brief
This phase II trial studies how well combination chemotherapy works in treating younger patients with newly diagnosed, non-metastatic desmoplastic medulloblastoma. Drugs used in chemotherapy, such as vincristine sulfate, cyclophosphamide, methotrexate, etoposide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Key facts
- Study ID
- NCT02017964
- Run by
- Children's Oncology Group
- People needed
- 26
- Starts
- 2013-12-24
- Expected to finish
- 2022-12-31
- Last updated by the study team
- 2023-01-09
Who can join
Age: any, up to 4. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must be newly diagnosed and have a confirmed histologic diagnosis of nodular desmoplastic (ND) medulloblastoma or medulloblastoma with extensive nodularity (MBEN) from rapid central pathology screening review; please note: patients with Gorlin syndrome are eligible
- Patient must have negative lumbar cerebrospinal fluid (CSF) cytology (lumbar CSF must be obtained unless medically contraindicated); CSF cytology for staging should be performed preferably no sooner than 14 days post operatively to avoid false positive CSF, ideally, CSF should be obtained between day 14 and day 21 to allow for final staging status before enrollment onto the study; Note: patients with positive CSF cytology obtained prior to 14 days after surgery may have cytology repeated to determine eligibility and final CSF status
- Patients must have:
- Pre-operative cranial magnetic resonance imaging (MRI) (recommended with gadolinium) or pre-operative computed tomography (CT) (recommended with contrast)
- Post-operative cranial MRI with and without gadolinium within 72 hours of surgery
- Spinal MRI pre-op with and without gadolinium or post-op with and without gadolinium preferably within 72 hours of surgery
- Patients must be enrolled on study within 31 days of definitive surgical resection at which time tissue is acquired to determine a diagnosis; patients must be enrolled before treatment begins; the date protocol therapy is projected to start must be no later than five (5) calendar days after the date of study enrollment; patients who are started on protocol therapy on a Phase II study prior to study enrollment will be considered ineligible
- Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Lansky for patients =< 16 years of age
- Patients must have a life expectancy of >= 8 weeks
- Patients who are receiving dexamethasone must be on a stable dose for at least 1 week prior to study entry
- Peripheral absolute neutrophil count (ANC) >= 1000/uL
- Platelet count >= 100,000/uL (transfusion independent)
- Hemoglobin >= 10.0 g/dL (may receive red blood cell [RBC] transfusions)
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m\^2 or a serum creatinine based on age/gender as follows:
- 1 month to < 6 months: 0.4 mg/dL
- 6 months to < 1 year: 0.5 mg/dL
- 1 to < 2 years: 0.6 mg/dL
- 2 to < 6 years: 0.8 mg/dL
- Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age
- Central nervous system function defined as:
- Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled
- Patients must not be in status, coma or assisted ventilation prior to study enrollment
You may not qualify if…
- Patients with metastatic disease by either MRI evaluation (brain and spine) or lumbar CSF cytology are not eligible
- Patients must not have received any prior tumor-directed therapy other than surgical intervention and corticosteroids
Where it is running
- Phoenix Childrens Hospital — Phoenix, Arizona, United States
- Banner University Medical Center - Tucson — Tucson, Arizona, United States
- Arkansas Children's Hospital — Little Rock, Arkansas, United States
- Kaiser Permanente Downey Medical Center — Downey, California, United States
- City of Hope Comprehensive Cancer Center — Duarte, California, United States
- Loma Linda University Medical Center — Loma Linda, California, United States
- Miller Children's and Women's Hospital Long Beach — Long Beach, California, United States
- Children's Hospital Los Angeles — Los Angeles, California, United States
- Valley Children's Hospital — Madera, California, United States
- UCSF Benioff Children's Hospital Oakland — Oakland, California, United States
- Kaiser Permanente-Oakland — Oakland, California, United States
- Children's Hospital of Orange County — Orange, California, United States
- Sutter Medical Center Sacramento — Sacramento, California, United States
- University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
- Rady Children's Hospital - San Diego — San Diego, California, United States
- UCSF Medical Center-Parnassus — San Francisco, California, United States
- UCSF Medical Center-Mission Bay — San Francisco, California, United States
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States
- Children's Hospital Colorado — Aurora, Colorado, United States
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver, Colorado, United States
- Connecticut Children's Medical Center — Hartford, Connecticut, United States
- Yale University — New Haven, Connecticut, United States
- Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
- MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
- Children's Hospital of Alabama — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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