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

Study Overview
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Brief Summary
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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.

Official Title
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Dose Finding Phase 1 Study of the Treatment of Recurrent/Relapsed Glioblastoma Multiforme With MPC-6827 in Combination With Carboplatin

Conditions
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Glioblastoma Multiforme

Intervention / Treatment
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* Drug: MPC-6827 + Carboplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose |  | After each cohort is enrolled and all subjects have completed 1 cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | Cycle 1 only | 
| Antitumor activity |  | Screening, end of each cycle, end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent, Relapsed, Glioblastoma, Multiforme