Phase 1 Study of MPC-6827 and Carboplatin in Recurrent/Relapsed Glioblastoma Multiforme

NCT ID: NCT00635557

Last Updated: 2011-03-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2011-08-31

Brief Summary

This is an open-label, dose finding, multiple-dose study in subjects with recurring/relapsing glioblastoma multiforme. Three dose levels of MPC-6827 will be administered with carboplatin to three separate cohorts. Study endpoints will include determination of the maximum tolerated dose, dose limiting toxicities, and evaluation of evidence of anti-tumor activity of MPC-6827 when given with carboplatin.

Conditions

Glioblastoma Multiforme

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

MPC-6827 + Carboplatin

MPC-6827 at 2.1mg/m2, 2.7mg/m2 or 3.3mg/m2 administered by intravenous infusion over 2 hours once weekly for three weeks in a 4 week cycle. Carboplatin at AUC4 administered by intravenous infusion over 1 hour on Day 1 of each 4 week cycle.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically proven WHO Grade IV glioblastoma multiforme at time of diagnosis or relapse
• Prior treatment with radiotherapy and temozolomide
• Evidence of measurable recurrent or residual primary tumor by contrast-enhanced MRI
• Be a minimum of 4 weeks since prior surgical resection, major surgical procedure, radiation therapy or cytotoxic chemotherapy (6 weeks since prior BCNU or CCNU)
• Have a Performance Scale of Karnofsky > 60%, ECOG < 2 or WHO < 2
• If steroids are needed, be on a stable or decreasing dose of steroids for at least 1 week

Exclusion Criteria

• Hypersensitivity to Cremophor EL
• Have evidence of current/active intratumor hemorrhage by MRI
• Have greater than second relapse
• Have had prior treatment with platinum-based chemotherapy
• Have cardiovascular disease
• Have cerebrovascular disease
• Have uncontrolled hypertension
• Have a cardiac ejection fraction < 50%
• Have Troponin-I elevated above the normal range

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Myrexis Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Myrexis Inc.

Principal Investigators

Andrew P. Beelen, MD

Role: STUDY_DIRECTOR

Myrexis Inc.

Locations

The Angeles Clinic and Research Institute

Los Angeles, California, United States

Emory University

Atlanta, Georgia, United States

Mt. Sinai School of Medicine

New York, New York, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

MPC-6827 GBM

Identifier Type: -

Identifier Source: secondary_id

MPC-6827-07-004

Identifier Type: -

Identifier Source: org_study_id