Nelfinavir Mesylate, Radiation Therapy, and Temozolomide in Treating Patients With Glioblastoma Multiforme

Phase 1

Terminated

• Conditions: Brain and Central Nervous System Tumors
• Interventions: Drug: nelfinavir mesylate; Drug: temozolomide; Procedure: adjuvant therapy; Radiation: radiation therapy

• Registration Number: NCT00915694
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

RATIONALE: 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.

PURPOSE: This phase I trial is studying the side effects and best dose of nelfinavir mesylate when given together with radiation therapy and temozolomide in treating patients with glioblastoma multiforme.

Detailed Description

OBJECTIVES:

Primary

* Determine the maximum tolerated dose of nelfinavir mesylate when given concurrently with radiotherapy and temozolomide followed by temozolomide alone in patients with glioblastoma multiforme.

* Determine the safety and dose-limiting toxicities of this regimen in these patients.

Secondary

* 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.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-06-05
• Study First Submitted QC: 2009-06-05
• Study First Posted: 2009-06-08
• Primary Completion: 2011-07
• Study Completion: 2015-12
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-22
• Last Update Posted: 2019-04-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	adjuvant therapy	NFV-RT-Tem
Single arm	radiation therapy	NFV-RT-Tem
Single arm	nelfinavir mesylate	NFV-RT-Tem
Single arm	temozolomide	NFV-RT-Tem

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose of nelfinavir mesylate	90 days
Dose-limiting toxicities as assessed by NCI CTC v3.0	90 days

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	One year
Overall survival	5 years

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States