This phase I trial is studying the side effects and best dose of nelfinavir mesylate (NFV) when given together with radiation therapy and temozolomide in treating patients with glioblastoma multiforme. Nelfinavir mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving nelfinavir mesylate together with radiation therapy and temozolomide may kill more tumor cells.
Additional locations may be listed on ClinicalTrials.gov for NCT00915694.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To determine the safety, dose-limiting toxicities, and maximally tolerated dose of NFV concurrently with radiation and temozolomide.
SECONDARY OBJECTIVES:
I. To determine the progression free survival (PFS) and overall survival (OS) with an exploratory analysis to compare the observed median value obtained in this study to the historical median values of 6.9 months and 14.6 months respectively.
OUTLINE: This is a dose-escalation study of nelfinavir mesylate.
Patients receive nelfinavir mesylate orally (PO) twice daily (BID) beginning 7-10 days before the initiation of chemoradiotherapy and continuing until the completion of chemoradiotherapy. Patients undergo radiotherapy once daily (QD) 5 days a week and receive concurrent temozolomide PO QD for 6 weeks. Beginning 4 weeks after completion of nelfinavir mesylate and chemoradiotherapy, patients receive temozolomide PO alone QD on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up periodically.
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorJay Fitzgerald Dorsey
