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Combination Chemotherapy Plus Radiation Therapy in Treating Adult Patients With Brain Cancer
This study has been completed.
Study NCT00003309   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: February 4, 2009   History of Changes

November 1, 1999
February 4, 2009
July 1998
March 2008   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00003309 on ClinicalTrials.gov Archive Site
 
 
 
Combination Chemotherapy Plus Radiation Therapy in Treating Adult Patients With Brain Cancer
A Phase II Trial of Preradiation Multiagent Chemotherapy for Adults With "Poor Risk" Medulloblastoma, PNET, and Disseminated Ependymoma

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.

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.

Phase II
Interventional
Treatment
Brain and Central Nervous System Tumors
  • Biological: filgrastim
  • Drug: cisplatin
  • Drug: cyclophosphamide
  • Drug: etoposide
  • Drug: vincristine sulfate
  • Procedure: adjuvant therapy
  • Radiation: radiation therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
33
 
March 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003309
 
CDR0000066256, ECOG-4397, SWOG-E4397
Eastern Cooperative Oncology Group
  • National Cancer Institute (NCI)
  • Southwest Oncology Group
Study Chair: Paul L. Moots, MD Vanderbilt-Ingram Cancer Center
Investigator: Larry Kleinberg, MD Sidney Kimmel Comprehensive Cancer Center
Study Chair: Geoffrey R. Barger, MD Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
September 2004

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