Clinical trial · Interventional
Combination Chemotherapy Plus Radiation Therapy in Treating Adult Patients With Brain Cancer
A Phase II Trial of Preradiation Multiagent Chemotherapy for Adults With "Poor Risk" Medulloblastoma, PNET, and Disseminated Ependymoma
NCT00003309CI-TRIAL-00067361completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy in treating adult patients with brain cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| cisplatin | Drug | Cisplatin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed central nervous system cancer including: * Medulloblastoma with either local residual disease of greater than 1 cm\^2 on MRI following resection or evidence of metastases (M1-4) * Other primitive neuroectodermal tumors * Ependymoma with evidence of subarachnoid metastases * Must have less than 1 cm of midline shift or no acute elevated intercranial pressure PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * WBC greater than 4,000/mm\^3 * Platelet count greater than 125,000/mm\^3 * Hemoglobin greater than 10 g/dL * No preexisting hematologic condition that would increase toxicity or limit ability to comply with evaluations and follow-up Hepatic: * Bilirubin less than 2 times upper limit of normal (ULN) * SGOT less than 2 times ULN * Alkaline phosphatase less than 2 times ULN * No preexisting hepatic condition that would increase toxicity or limit ability to comply with evaluations and follow-up Renal: * Creatinine greater than 70 mL/min * No preexisting renal condition that would increase toxicity or limit ability to comply with evaluations and follow-up Pulmonary: * No history of significant pulmonary disease or, if there is preexisting pulmonary disease, then DLCO greater than 60% of predicted * No preexisting pulmonary condition that would increase toxicity or limit ability to comply with evaluations and follow-up Other: * No preexisting psychiatric condition that would increase toxicity or limit ability to comply with evaluations and follow-up * No prior or concurrent malignancies within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * No increasing doses of steroids for intracranial disease within 3 days of registration Radiotherapy: * No prior radiotherapy Surgery: * 10-28 days since prior surgical resection OR * At least 5 days since prior biopsy
References
Publications (1)
- RESULTMoots PL, O'Neill A, Barger GR, et al.: Toxicities associated with chemotherapy followed by craniospinal radiation for adults with poor-risk medulloblastoma/PNET and disseminated ependymoma: a preliminary report of ECOG 4397. [Abstract] J Clin Oncol 22 (Suppl 14): A-1573, 125s, 2004.