Radiation Therapy With or Without RSR13 in Treating Patients With Brain Metastases

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Radiographically, histologically, or cytologically confirmed brain metastases with histologically or cytologically confirmed primary malignancy except the following:
• •* Small cell lung cancer, germ cell tumors, and lymphomas
• •No leptomeningeal metastases
• •PATIENT CHARACTERISTICS:
• •Age:
• •18 and over
• •Performance status:
• •Karnofsky 70-100%
• •Life expectancy:
• •Not specified
• •Hematopoietic:
• •Hemoglobin at least 10 g/dL
• •WBC at least 2,000/mm3
• •Platelet count at least 75,000/mm3
• •Hepatic:
• •Bilirubin no greater than 2.0 mg/dL
• •ALT and AST no greater than 3 times upper limit of normal
• •Renal:
• •Creatinine no greater than 2.0 mg/dL
• •Pulmonary:
• •Forced vital capacity and forced expiratory volume at least 50% of normal in patients with significant intrathoracic tumor involvement, chronic obstructive pulmonary disease, interstitial lung disease, or pulmonary embolism
• •Resting and exercise oxygen saturation at least 90% on room air
• •Other:
• •No other concurrent active malignancy from a second histologic site
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •No prior biologic therapy or immunotherapy for brain metastases
• •At least 28 days since prior investigational biologic therapy
• •Chemotherapy:
• •No prior chemotherapy for brain metastases
• •No chemotherapy for brain metastases for at least one month following radiation therapy
• •At least 7 days since prior chemotherapy for primary tumor or extracranial metastases
• •No planned chemotherapy during radiation therapy
• •Endocrine therapy:
• •No prior hormonal therapy for brain metastases
• •Prior or concurrent corticosteroid therapy allowed
• •Radiotherapy:
• •No prior whole brain radiotherapy for brain metastases
• •No prior stereotactic radiosurgery for brain metastases
• •Surgery:
• •Prior surgery allowed for brain metastases if at least one measurable lesion remains
• •Other:
• •At least 28 days since prior investigational drug or device
• •No prior RSR13