Radiation Therapy With or Without Thalidomide in Treating Patients With Brain Metastases
Completed · Phase 3
Conditions studied: Tumors Metastatic to Brain
In brief
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.
Key facts
- Study ID
- NCT00033254
- Run by
- National Cancer Institute (NCI)
- People needed
- 332
- Starts
- 2002-03-01
- Last updated by the study team
- 2020-10-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
Where it is running
- Radiation Therapy Oncology Group — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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