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

• Status: Unknown status
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Myrexis Inc.
• Treatments: Carboplatin

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