Moffit CC & Research 5/5/03 :

Clinical Trials. Several phase II trials with thalidomide as a single agent for malignant gliomas have been published.[111-113] The doses have ranged between 100 and 1200 mg per day. For this patient population, thalidomide is a safe drug with acceptable toxicity that appears to have little antitumor activity. We recently analyzed data from NABTC 99-04, a phase II trial with thalidomide plus temozolomide for recurrent GBM. Patients received thalidomide at 400 mg orally every 12 hours on a continuous dosing schedule. The best response rate (partial response plus stable disease rate) was 47%, with a median PFS of 13 weeks.[114] This out-come was not significantly different from the 6-month PFS in historical data from recurrent GBM. Recent data from a phase I trial suggest that the combination of temozolomide and thalidomide can be effective in the treatment of brain metastases from melanoma,[115] which raises the possibility that thalidomide is more effective for treating brain metastases than primary brain tumors.