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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Glioblastoma Multiforme

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Outcome Time Frame:

After each cohort is enrolled and all subjects have completed 1 cycle

Safety Issue:

Yes

Principal Investigator

Andrew P. Beelen, MD

Investigator Role:

Study Director

Investigator Affiliation:

Myrexis Inc.

Authority:

United States: Food and Drug Administration

Study ID:

MPC-6827-07-004

NCT ID:

NCT00635557

Start Date:

March 2008

Completion Date:

August 2011

Related Keywords:

  • Glioblastoma Multiforme
  • Recurrent
  • Relapsed
  • Glioblastoma
  • Multiforme
  • Glioblastoma

Name

Location

Emory UniversityAtlanta, Georgia  30322
University of Texas MD Anderson Cancer CenterHouston, Texas  77030
Mt. Sinai School of MedicineNew York, New York  10029
The Angeles Clinic and Research InstituteLos Angeles, California  90025
Huntsman Cancer Institute at the University of UtahSalt Lake City, Utah  84112