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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00003309
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 27, 2010
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Southwest Oncology Group
Information provided by:
Eastern Cooperative Oncology Group

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

Resource links provided by the National Library of Medicine


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, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003309


Locations
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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
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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
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.

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Responsible Party: Group Chair, Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00003309    
Other Study ID Numbers: CDR0000066256
E4397
SWOG-E4397
First Posted: January 27, 2003    Key Record Dates
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:
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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