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

Study Description

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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

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Study Type :	Interventional (Clinical Trial)
Estimated 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 :	July 1998
Actual Primary Completion Date :	March 2004

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Illinois
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, United States, 60611-4494
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Iowa
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States, 52403-1206
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309-1016
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Michigan
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
United States, Minnesota
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, Tennessee
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232-6307
United States, Wisconsin
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
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
Study Chair:	Geoffrey R. Barger, MD	Barbara Ann Karmanos Cancer Institute

More Information

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Publications of Results:

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.

Responsible Party:	Group Chair, Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:	NCT00003309 History of Changes
Other Study ID Numbers:	CDR0000066256; E4397; SWOG-E4397
First Posted:	January 27, 2003
Last Update Posted:	January 27, 2010
Last Verified:	January 2010

Keywords provided by Eastern Cooperative Oncology Group:

adult medulloblastoma; adult anaplastic ependymoma; adult ependymoma; adult supratentorial primitive neuroectodermal tumor (PNET)

Additional relevant MeSH terms:

Ependymoma; Nervous System Neoplasms; Central Nervous System Neoplasms; Medulloblastoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms by Site; Nervous System Diseases; Neuroectodermal Tumors, Primitive	Cyclophosphamide; Etoposide; Vincristine; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors