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Combination Chemotherapy Plus Radiation Therapy in Treating Adult Patients With Brain Cancer



Combination Chemotherapy Plus Radiation Therapy in Treating Adult Patients With Brain Cancer

For Condition: adult malignant ependymoma,Adult Medulloblastoma
Status: Recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI),Southwest Oncology Group
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
PaulMoots,  Study Chair,  Vanderbilt-Ingram Cancer Center

CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids,  Iowa,  52403-1206
United States
Recruiting Martin  Wiesenfeld 319-363-8303

CCOP - Wichita *Recruiting*
Wichita,  Kansas,  67214-3882
United States
Recruiting Shaker  Dakhil 316-268-5784

Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago,  Illinois,  60611
United States
Recruiting Al  Benson 312-695-1382

H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa,  Florida,  33612-9497
United States
Recruiting Cancer  Answers 813-972-4673

CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines,  Iowa,  50309-1016
United States
Recruiting Roscoe  Morton 515-244-7586

CCOP - Metro-Minnesota *Recruiting*
St. Louis Park,  Minnesota,  55416
United States
Recruiting Patrick  Flynn 952-993-15175

Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee,  Wisconsin,  53226-3596
United States
Recruiting David  Vesole 414-805-4646

Veterans Affairs Medical Center - Lakeside Chicago *Recruiting*
Chicago,  Illinois,  60611-4494
United States
Recruiting Timothy  Kuzel 312-469-3748

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville,  Tennessee,  37232-6307
United States
Recruiting David  Johnson 615-343-9454

Norris Cotton Cancer Center at Dartmouth Medical School *Recruiting*
Lebanon,  New Hampshire,  03756-0002
United States
Recruiting Camilo  Fadul 603-650-6312

CCOP - Kalamazoo *Recruiting*
Kalamazoo,  Michigan,  49007-3731
United States
Recruiting Raymond  Lord 269-373-7488

CCOP - Carle Cancer Center *Recruiting*
Urbana,  Illinois,  61801
United States
Recruiting Kendrith  Rowland 217-383-4083

CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield,  Wisconsin,  54449
United States
Recruiting Tarit  Banerjee 715-387-5134


Additional Information:
Study ID Numbers:
  CDR0000066256;  ECOG-4397,SWOG-E4397
Study Start Date: 
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003309

Other Adult Malignant Ependymoma Studies:
1. Carmustine Followed By Surgery in Treating Patients With Recurrent Supratentorial Malignant Glioma or Metastatic Brain Neoplasm

2. Etoposide Plus Cisplatin in Treating Patients With Recurrent Ependymomas

3. Carmustine in Treating Patients With Recurrent Malignant Glioma

4. Combination Chemotherapy Plus Radiation Therapy in Treating Adult Patients With Brain Cancer

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Combination Chemotherapy Plus Radiation Therapy in Treating Adult Patients With Brain Cancer

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