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

NCT00003309 | Completed Phase 2

• 3 other identifiers: CDR0000066256E4397SWOG-E4397
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 14

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.

Conditions

Brain and Central Nervous System Tumors

Keywords

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

Interventions

filgrastim BIOLOGICAL

cisplatin DRUG

cyclophosphamide DRUG

etoposide DRUG

vincristine sulfate DRUG

adjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator
• SWOG Cancer Research Network: collaborator

Study Sites (14)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Veterans Affairs Medical Center - Lakeside Chicago

Chicago, Illinois, 60611-4494, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

Nashville, Tennessee, 37232-6307, United States

Location

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226-3596, United States

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Central Nervous System Neoplasms; Medulloblastoma; Ependymoma

Interventions

Filgrastim; Cisplatin; Cyclophosphamide; Etoposide; Vincristine; Chemotherapy, Adjuvant; Radiotherapy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neuroectodermal Tumors, Primitive; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: May 4, 1999
• Primary Completion: March 1, 2004
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

US (14)