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Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Astrocytoma



Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Astrocytoma

For Condition: adult anaplastic astrocytoma,Quality of Life
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , North Central Cancer Treatment Group
Synopsis: 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 with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients with newly diagnosed anaplastic astrocytoma.
Details: OBJECTIVES: I. Determine the efficacy of carmustine, cisplatin, and etoposide given prior to and during radiotherapy in patients with anaplastic astrocytoma. II. Assess the toxic effects associated with this regimen in these patients. III. Evaluate this regimen in terms of fatigue, depression, excessive daytime somnolence, and quality of life in these patients. PROTOCOL OUTLINE: Patients receive carmustine IV over 1 hour on days 1-3, oral etoposide on days 1-21 and 29-49, and cisplatin IV over 1-2 hours on days 1-3 and 29-31. Treatment repeats every 8 weeks for 3 courses. Patients receive radiotherapy concurrently with the third course of chemotherapy. Quality of life is assessed every 4 months for 1 year, every 6 months for 4 years, then annually for 5 years. Patients are followed every 4 months for 1 year, every 6 months for 4 years, then annually for 5 years. PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study within 20 months.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed newly diagnosed anaplastic astrocytoma - No oligodendrogliomas or oligoastrocytomas --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: At least 5 years since prior chemotherapy - Endocrine therapy: Concurrent corticosteroids allowed - Radiotherapy: At least 5 years since prior radiotherapy - Surgery: Not specified --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: WBC at least 3500/mm3; Platelet count at least 130,000/mm3 - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); SGOT no greater than 2 times ULN - Renal: Creatinine no greater than 0.5 mg/dL - Other: Not pregnant or nursing; Fertile patients must use effective contraception; No uncontrolled infection; No concurrent malignant disease or major medical problem except superficial skin cancers
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
JanBuckner,  Study Chair,  North Central Cancer Treatment Group

CCOP - Toledo Community Hospital Oncology Program
Toledo,  Ohio,  43623-3456
United States
 

CCOP - Metro-Minnesota
St. Louis Park,  Minnesota,  55416
United States
 

Siouxland Hematology-Oncology
Sioux City,  Iowa,  51101-1733
United States
 

Altru Health Systems
Grand Forks,  North Dakota,  58201
United States
 

Mayo Clinic Cancer Center
Rochester,  Minnesota,  55905
United States
 

CCOP - Sioux Community Cancer Consortium
Sioux Falls,  South Dakota,  57105-1080
United States
 

CCOP - Illinois Oncology Research Association
Peoria,  Illinois,  61602
United States
 

CCOP - Missouri Valley Cancer Consortium
Omaha,  Nebraska,  68131
United States
 

CCOP - Duluth
Duluth,  Minnesota,  55805
United States
 

CentraCare Clinic
St. Cloud,  Minnesota,  56303
United States
 

Quain & Ramstad Clinic, P.C.
Bismark,  North Dakota,  58501
United States
 

CCOP - Scottsdale Oncology Program
Scottsdale,  Arizona,  85259-5404
United States
 

CCOP - Cedar Rapids Oncology Project
Cedar Rapids,  Iowa,  52403-1206
United States
 

CCOP - Wichita
Wichita,  Kansas,  67214-3882
United States
 

CCOP - Ochsner
New Orleans,  Louisiana,  70121
United States
 

Rapid City Regional Hospital
Rapid City,  South Dakota,  57709
United States
 

CCOP - Geisinger Clinic and Medical Center
Danville,  Pennsylvania,  17822-2001
United States
 

CCOP - Iowa Oncology Research Association
Des Moines,  Iowa,  50309-1016
United States
 


Additional Information:
Study ID Numbers:
  CDR0000066700;  NCCTG-987251
Study Start Date: February 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003621

Other Adult Anaplastic Astrocytoma Studies:
1. Atrasentan in Treating Patients With Progressive or Recurrent Malignant Glioma

2. Carmustine in Treating Patients With Recurrent Malignant Glioma

3. Irinotecan in Treating Patients With Recurrent Malignant Glioma

4. Vaccine Therapy in Treating Patients With Malignant Glioma

5. Photodynamic Therapy in Treating Patients With Recurrent Malignant Supratentorial Gliomas

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