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

Sponsor

Eastern Cooperative Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00003309

Collaborator

National Cancer Institute (NCI) (NIH), Southwest Oncology Group (Other)

Enrollment

Locations

2.4

Patients Per Site

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors	Biological: filgrastim Drug: cisplatin Drug: cyclophosphamide Drug: etoposide Drug: vincristine sulfate Procedure: adjuvant therapy Radiation: radiation therapy	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

33 participants

Primary Purpose:

Treatment

Official Title:

A Phase II Trial of Preradiation Multiagent Chemotherapy for Adults With "Poor Risk" Medulloblastoma, PNET, and Disseminated Ependymoma

Study Start Date :

Jul 1, 1998

Actual Primary Completion Date :

Mar 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612-9497
2	Veterans Affairs Medical Center - Lakeside Chicago	Chicago	Illinois	United States	60611-4494
3	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois	United States	60611
4	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
5	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa	United States	52403-1206
6	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309-1016
7	CCOP - Wichita	Wichita	Kansas	United States	67214-3882
8	CCOP - Kalamazoo	Kalamazoo	Michigan	United States	49007-3731
9	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007
10	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
11	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756-0002
12	Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center	Nashville	Tennessee	United States	37232-6307
13	CCOP - Marshfield Clinic Research Foundation	Marshfield	Wisconsin	United States	54449
14	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin	United States	53226-3596

Sponsors and Collaborators

Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Southwest Oncology Group

Investigators

Study Chair: Paul L. Moots, MD, Vanderbilt-Ingram Cancer Center
Study Chair: Larry Kleinberg, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Chair: Geoffrey R. Barger, MD, Barbara Ann Karmanos Cancer Institute