A Phase III, Randomized, Open-Label, Comparative Study of Standard Whole Brain Radiation Therapy With or Without RSR13 in 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