S0001 RT and Carmustine With or Without O6BG in Patients With New Glioblastoma Multiforme or Gliosarcoma

Launched by SWOG CANCER RESEARCH NETWORK · Jan 26, 2003

Keywords

ClinConnect Summary

OBJECTIVES:

* Compare the overall survival, failure-free survival, and progression-free survival of patients with newly diagnosed glioblastoma multiforme or gliosarcoma treated with radiotherapy and carmustine with or without O6-benzylguanine.
* Compare the frequency and severity of toxic effects of these regimens in these patients.
* Correlate the survival of these patients with the expression of O6-alkylguanine-DNA alkyltransferase.

OUTLINE: This is a randomized study. Patients are stratified according to age (under 50 vs 50 and over), prior surgery (biopsy only vs resection), and Zubro...

Gender

ALL

Eligibility criteria

• DISEASE CHARACTERISTICS:
• • Histologically confirmed glioblastoma multiforme or gliosarcoma
• • Biopsy or surgical resection within the past 28 days
• • MRI\* with gadolinium performed before registration
• • Patients who undergo a simple biopsy only require preoperative MRI\* with gadolinium
• • No more than 2 noncontiguous tumor sites based on T2-weighted MRI (in 3 dimensions)\*
• • No prior radiotherapy-delivered cephalad to the interspace between the seventh cervical and the first thoracic vertebral body NOTE: \*If an MRI is not medically feasible, patients may have a CT scan with contrast
• PATIENT CHARACTERISTICS:
• Age:
• • 18 and over
• Performance status:
• • Zubrod 0-2
• Life expectancy:
• • Not specified
• Hematopoietic:
• • Absolute neutrophil count at least 3,000/mm\^3
• • Platelet count at least 100,000/mm\^3
• • Hemoglobin at least 8 g/dL
• Hepatic:
• • Bilirubin no greater than 2 times upper limit of normal (ULN)
• • SGOT/SGPT no greater than 2 times ULN
• • Alkaline phosphatase no greater than 2 times ULN
• • PT/PTT no greater than 1.2 times ULN
• Renal:
• • Not specified
• Cardiac:
• * No severe cardiac disease, including any of the following:
• • Uncontrolled arrhythmias or conduction defects
• • Major problems with edema (e.g., residual swelling in the legs from deep vein thrombosis)
• • Recent coronary artery disease
• • Poorly controlled hypertension (i.e., diastolic blood pressure greater than 110 mm Hg and/or systolic blood pressure greater than 180 mm Hg)
• Pulmonary:
• • DLCO at least 70% of predicted
• • No severe pulmonary disease
• Other:
• • HIV negative
• • No severe Cushing's syndrome
• • No known allergies to any of the study drugs
• • No major psychiatric illness
• • No poorly controlled diabetes complicated by steroid treatment
• • No other medical illness that cannot be adequately controlled or that would preclude study participation
• • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
• • Not pregnant or nursing
• • Fertile patients must use effective contraception
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• • Not specified
• Chemotherapy:
• • No prior chemotherapy
• • No other concurrent antitumor chemotherapy
• Endocrine therapy:
• • No concurrent hormonal therapy except postmenopausal estrogen replacement therapy
• • Corticosteroids at stable or decreasing dose for tumor edema allowed
• Radiotherapy:
• • See Disease Characteristics
• • No prior radiotherapy
• • No other concurrent radiotherapy (including intensity-modulated radiotherapy) to the index lesion(s)
• Surgery:
• • See Disease Characteristics
• • No concurrent antitumor surgery
• Other:
• • No other concurrent investigational drugs
• • No other concurrent antineoplastic drugs or therapy