Phase II study of salvage therapy with high-dose tamoxifen and oral etoposide for recurrent malignant glioma

Abstract

Background: Salvage chemotherapy regimens for patients with recurrent glioma are limited in their efficacy. Reports of antitumor activity of the oral agents etoposide (VP-16®, Immunex Corporation) and high-dose tamoxifen (Nolvadex®, AstraZeneca) prompted this Phase II study. Tamoxifen and etoposide may be synergistic in their antitumor effects. Both agents are administered orally, are well tolerated individually and do not have overlapping toxicities. We report the results of a Phase II study of this combination as salvage therapy for patients with recurrent glioma. Methods: Patients received tamoxifen at an escalating dose from 120 mg/day to 240 mg/day over a 1-week period, after which time etoposide 50 mg/m2/day for 3 weeks was added to the regimen. Patients remained on tamoxifen continuously and the etoposide was repeated after a 2-week break. This 10-week cycle was repeated until tumor progression or unacceptable toxicity occurred. Response assessments using neuroradiographic imaging and clinical eval...