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

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00635557

Enrollment

Registered

2008-03-13

Start date

2008-03-31

Completion date

2011-08-31

Last updated

2011-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma Multiforme

Keywords

Recurrent, Relapsed, Glioblastoma, Multiforme

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.

Interventions

DRUGMPC-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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Maximum tolerated dose	After each cohort is enrolled and all subjects have completed 1 cycle

Secondary

Measure	Time frame
Pharmacokinetics	Cycle 1 only
Antitumor activity	Screening, end of each cycle, end of study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026