A Trial of the Protease Inhibitor Nelfinavir and Concurrent Radiation and Temozolomide in Patients With WHO Grade IV Glioma
Status:
Completed
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
Summary
This phase I trial will determine safety, dose-limiting toxicities (DLT) and maximum
tolerable dose (MTD) of the protease inhibitor, Nelfinavir (NFV), when given with
chemoradiotherapy as post-operative therapy for glioblastoma multiforme (GBM). Oral NFV is a
standard therapy for patients with HIV and the safety of 1250 mg BID NFV is well-established.
Case studies have also reported that HIV patients have received radiotherapy for cancer,
while on 1250 mg BID NFV. This is the first trial of oral NFV and chemoradiotherapy for GBM
patients. Although unacceptable toxicity is unlikely, two NFV dose levels (625, and 1250 mg
BID) will be evaluated in a cohort escalation design of 3-6 subjects. At the MTD, 19
additional subjects will be enrolled to generate pilot data on radiographic response and to
evaluate further toxicity. A maximum of 31 subjects will be enrolled on the trial.
Phase:
Phase 1
Details
Lead Sponsor:
Abramson Cancer Center of the University of Pennsylvania