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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

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date January 27, 2010
Study Start Date  ICMJE July 1998
Actual Primary Completion Date March 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Chemotherapy Plus Radiation Therapy in Treating Adult Patients With Brain Cancer
Official Title  ICMJE A Phase II Trial of Preradiation Multiagent Chemotherapy for Adults With "Poor Risk" Medulloblastoma, PNET, and Disseminated Ependymoma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Brain and Central Nervous System Tumors
Intervention  ICMJE
  • Biological: filgrastim
  • Drug: cisplatin
  • Drug: cyclophosphamide
  • Drug: etoposide
  • Drug: vincristine sulfate
  • Procedure: adjuvant therapy
  • Radiation: radiation therapy
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February¬†8,¬†2007)
33
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date March 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00003309
Other Study ID Numbers  ICMJE CDR0000066256
E4397
SWOG-E4397
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Group Chair, Eastern Cooperative Oncology Group
Study Sponsor  ICMJE Eastern Cooperative Oncology Group
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Southwest Oncology Group
Investigators  ICMJE
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
PRS Account Eastern Cooperative Oncology Group
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP