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

NCT ID: NCT00003309

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-05-04

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.

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.

Conditions

Brain and Central Nervous System Tumors

Study Design

• Primary Study Purpose: TREATMENT

Interventions

filgrastim

Intervention Type: BIOLOGICAL

cisplatin

Intervention Type: DRUG

cyclophosphamide

Intervention Type: DRUG

etoposide

Intervention Type: DRUG

vincristine sulfate

Intervention Type: DRUG

adjuvant therapy

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role: collaborator

Eastern Cooperative Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Eastern Cooperative Oncology Group

Principal Investigators

Paul L. Moots, MD

Role: STUDY_CHAIR

Vanderbilt-Ingram Cancer Center

Larry Kleinberg, MD

Role: STUDY_CHAIR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Geoffrey R. Barger, MD

Role: STUDY_CHAIR

Barbara Ann Karmanos Cancer Institute

Locations

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Veterans Affairs Medical Center - Lakeside Chicago

Chicago, Illinois, United States

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

CCOP - Carle Cancer Center

Urbana, Illinois, United States

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, United States

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, United States

CCOP - Wichita

Wichita, Kansas, United States

CCOP - Kalamazoo

Kalamazoo, Michigan, United States

West Michigan Cancer Center

Kalamazoo, Michigan, United States

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, United States

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

Nashville, Tennessee, United States

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, United States

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, United States

Countries

United States

References

Moots 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.

Reference Type: RESULT

Other Identifiers

E4397

Identifier Type: -

Identifier Source: secondary_id

SWOG-E4397

Identifier Type: -

Identifier Source: secondary_id

CDR0000066256

Identifier Type: -

Identifier Source: org_study_id