NCT Number: NCT00003309
Combination Chemotherapy Plus Radiation Therapy in Treating Adult Patients With Brain Cancer
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.
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Notify MeKey information
Conditions
Age range
18 year–120 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
About this study
OBJECTIVES:
- Determine the complete and partial response rate of patients with adult medulloblastoma, primitive neuroectodermal tumor, or disseminated ependymoma treated with preradiation combination chemotherapy.
- Determine the progression free survival and overall survival of these adult patients treated with combination chemotherapy followed by craniospinal radiation.
- Determine the toxic effects associated with this treatment in these patients.
OUTLINE: Patients receive cisplatin IV over 6 hours, etoposide IV, and vincristine IV over 1-2 minutes on day 1; etoposide IV and cyclophosphamide IV over 1-2 hours on days 2-3; filgrastim (G-CSF) subcutaneously (SC) on days 4-13; and vincristine IV over 1-2 minutes on day 15. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Within 4-6 weeks after the last chemotherapy course, patients undergo radiotherapy 5 days a week for 6 to 7 weeks.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5-10 years.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study within 3 years.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Cisplatin
DrugCyclophosphamide
Drugetoposide
Drugvincristine sulfate
Drugadjuvant therapy
Procedureradiation therapy
RadiationSponsors and collaborators
Lead sponsor
Eastern Cooperative Oncology Group
Network
Collaborators
- National Cancer Institute (NCI)
- SWOG Cancer Research Network
Registry information
Official study title
A Phase II Trial of Preradiation Multiagent Chemotherapy for Adults With "Poor Risk" Medulloblastoma, PNET, and Disseminated Ependymoma
Important dates
- Study start
- 1999
- Primary completion
- 2004
- First posted
- Jan 27, 2003
- Registry last updated
- Jun 22, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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