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

• Status: Completed
• Trial end date: 2003-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as RSR13 may make tumor cells more sensitive to radiation therapy.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the brain with or without RSR13 in treating patients who have brain metastases.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spectrum Pharmaceuticals, Inc
• Treatments: Efaproxiral

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