Back to resultsPhase 1 Study of MPC-6827 and Carboplatin in Recurrent/Relapsed Glioblastoma Multiforme
Primary Purpose
Glioblastoma Multiforme
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MPC-6827 + Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring Recurrent, Relapsed, Glioblastoma, Multiforme
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
Sites / Locations
- The Angeles Clinic and Research Institute
- Emory University
- Mt. Sinai School of Medicine
- University of Texas MD Anderson Cancer Center
- Huntsman Cancer Institute at the University of Utah
Outcomes
Primary Outcome Measures
Maximum tolerated dose
Secondary Outcome Measures
Pharmacokinetics
Antitumor activity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00635557
Brief Title
Phase 1 Study of MPC-6827 and Carboplatin in Recurrent/Relapsed Glioblastoma Multiforme
Official Title
Dose Finding Phase 1 Study of the Treatment of Recurrent/Relapsed Glioblastoma Multiforme With MPC-6827 in Combination With Carboplatin
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
August 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Myrexis Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme
Keywords
Recurrent, Relapsed, Glioblastoma, Multiforme
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MPC-6827 + Carboplatin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximum tolerated dose
Time Frame
After each cohort is enrolled and all subjects have completed 1 cycle
Secondary Outcome Measure Information:
Title
Pharmacokinetics
Time Frame
Cycle 1 only
Title
Antitumor activity
Time Frame
Screening, end of each cycle, end of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew P. Beelen, MD
Organizational Affiliation
Myrexis Inc.
Official's Role
Study Director
Facility Information:
Facility Name
The Angeles Clinic and Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Mt. Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Huntsman Cancer Institute at the University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase 1 Study of MPC-6827 and Carboplatin in Recurrent/Relapsed Glioblastoma Multiforme
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