A Phase I Trial of the Protease Inhibitor Nelfinavir and Concurrent Radiation and Temozolomide in Patients With WHO Grade IV Glioma
- Determine the maximum tolerated dose of nelfinavir mesylate when given concurrently
with radiotherapy and temozolomide followed by temozolomide alone in patients with
- Determine the safety and dose-limiting toxicities of this regimen in these patients.
- Determine the progression-free survival (PFS) and overall survival (OS) of patients
treated with this regimen.
- Compare the observed median values of PFS and OS 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 oral nelfinavir mesylate twice daily beginning 7-10 days before the
initiation of chemoradiotherapy and continuing until the completion of chemoradiotherapy.
Patients undergo radiotherapy once daily 5 days a week and receive concurrent oral
temozolomide once daily for 6 weeks. Beginning 4 weeks after completion of nelfinavir
mesylate and chemoradiotherapy, patients receive oral temozolomide alone once daily 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 periodically.
Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of nelfinavir mesylate
Jay F. Dorsey, MD, PhD
Abramson Cancer Center of the University of Pennsylvania
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|