Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Anaplastic Astrocytoma

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 2

Conditions: Brain and Central Nervous System Tumors

Treatments: Drug: etoposide; Drug: carmustine; Drug: cisplatin; Radiation: radiation therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00003621

NCCTG-987251

CDR0000066700 (Registry Identifier)

Details and patient eligibility

About

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 who have newly diagnosed anaplastic astrocytoma.

Full description

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.

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, and then annually for 5 years. Patients are followed every 3 months for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study within 20 months.

Enrollment: 29 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS: Histologically confirmed, newly diagnosed, anaplastic astrocytoma No oligodendrogliomas or oligoastrocytomas

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

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

carmustine + etoposide + cisplatin + radiation therapy

Experimental group

Description:

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, and then annually for 5 years. Patients are followed every 3 months for 5 years and then annually thereafter.

Treatment:

Drug: etoposide

Drug: cisplatin

Drug: carmustine

Radiation: radiation therapy