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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Randomized phase III trial to compare the effectiveness of radiation therapy with or without thalidomide in treating patients who have brain metastases. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as thalidomide may stop the growth of brain metastases by stopping blood flow to the tumor. It is not yet known whether radiation therapy is more effective with or without thalidomide in treating brain metastases.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Collaborator: NRG Oncology
• Treatments: Thalidomide

Criteria

Inclusion Criteria:

• Histologically confirmed extracranial primary malignancy

• Multiple brain metastases

• At least 1 measurable brain metastasis by MRI

• More than 4.0 cm

• Located in midbrain or brainstem (radiosurgery ineligible)

• Performance status - Zubrod 0-1

• At least 8 weeks

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 11 g/dL*

• Hematocrit at least 35%*

• Bilirubin no greater than 1.5 mg/dL

• ALT no greater than 2 times normal

• Creatinine no greater than 1.5 mg/dL

• BUN no greater than 25 mg/dL

• No history of deep venous thrombosis

• No sensory neuropathy grade 2 or greater

• No known AIDS

• No other major medical illness or psychiatric impairments that would preclude study therapy

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier method of contraception during and for at least 4 weeks after study

• No prior thalidomide

• More than 2 weeks since prior chemotherapy

• Concurrent chemotherapy allowed if more than 6 weeks past study entry (allowed during first 6 weeks of study if disease progression occurs)

• See Disease Characteristics

• No prior radiotherapy to the head or neck

• No prior radiosurgery

• Prior resection of brain metastases allowed

• No concurrent anticoagulant therapy