Thalidomide with carmustine active against brain tumors

Results of a phase II trial indicate that combination therapy with thalidomide and carmustine is well tolerated and shows activity against recurrent high-grade gliomas, researchers report in the July 15th issue of the Journal of Clinical Oncology.

“The rationale behind the trial,” lead investigator Dr. Howard A. Fine told Reuters Health, “was to explore the hypothesis, based on preclinical data, that agents with anti-angiogenic properties–thalidomide–work additively or synergistically with cytotoxic agents–carmustine. I believe the results of our study are consistent with that hypothesis, although far from conclusive.”Dr. Fine of the National Cancer Institute, Bethesda, Maryland and colleagues studied 40 patients. All subjects had a histologic diagnosis of high-grade gliomas and radiographic evidence of tumor progression after standard surgery, radiation and chemotherapy.Mild myelosuppression and mild-to-moderate sedation were the most common side effects of the treatment.The median progression-free survival of 100 days and the 24% objective radiographic response rate, “compared favourably with data from historical controls,” the investigators write.”This particular combination,” Dr. Fine concluded, “needs to be evaluated in an expanded multi-institutional phase II trial in order to see if the positive data holds up to this more rigorous study design. We are in process of designing such a trial now.”(Source: J Clin Oncol 2003; 21:2299-2304: Reuters Health: David Douglas: July 15, 2003: Oncolink)