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ASTRO Patient Summary: A Phase I Clinical Trial Assessing Temozolamide and Tamoxifen with Concomitant Radiotherapy for the Treatment of High-Grade Gliomas

Carolyn Vachani, RN, MSN, AOCN
The Abramson Cancer Center of the University of Pennsylvania
Last Modified: October 27, 2005

A Phase I Clinical Trial Assessing Temozolamide and Tamoxifen with Concomitant Radiotherapy for the Treatment of High-Grade Gliomas

There are limited therapies available for patients with high-grade gliomas. One particular problem is finding medications that are able to cross the blood-brain barrier in amounts significant enough to treat the tumor. Recent studies have found that temozolamide in conjunction with radiation therapy provides improved survival. Laboratory studies have found that tamoxifen, a hormonal agent used in breast cancer treatment, is able to cross the blood-brain barrier and has some effect on glioma cells. This is a phase I trial, which means the goal is to establish the highest dose that patients can tolerate without major side effects. The study gave tamoxifen in escalating doses, along with temozolamide and radiation. The highest dose of tamoxifen (maximum tolerated dose) was determined to be 100mg per m2 (body surface area) per day. The study had promising results in survival, with an average survival of 15.5 months, with 4 patients surviving beyond 30 months and 3 still alive at 45.9 months. The 2-year overall survival rate was 35%. This regimen is sure to move into a larger phase II study to see if the results are similar in a larger group of patients, as these results are relatively promising for a disease with typically dismal outcomes.