Phase I/II Bevacizumab Versus Bevacizumab Plus TPI 287 for Recurrent Glioblastoma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01582152
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Brain Neoplasms
  • Central Nervous System Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TPI287 — DRUG
    Phase I Starting Dose: 160 mg/m2 given by vein on Day 1 every three weeks of a 42 Day cycle. Phase II Starting Dose: Maximum Tolerated Dose (MTD) from Phase I.
  • Bevacizumab — DRUG
    Arm A + B: 10 mg/kg by vein every 2 weeks of a 42 day cycle.

Study Details

The goal of Part I of this clinical research study is to find the highest tolerable dose of TPI 287 that can be given with bevacizumab to patients with glioblastoma. The goal of Part II is to learn if TPI 287 when given with bevacizumab can help to control glioblastoma better than when bevacizumab is given alone. The safety of the drug combination will also be studied. TPI 287 is similar to a type of chemotherapy drug called a taxane and is designed to block a protein (tubulin) that helps the cancer cells divide. By blocking the tubulin, the drug may be able to cause the cancer cells to shrink or stop growing. Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels.

Key Dates

First listed
Apr 20, 2012
Start date
Jul 31, 2012
Status verified
May 2019
Primary completion
Mar 31, 2016
Completion
Mar 31, 2016

Study Design

Enrollment
12 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: TPI 287 + Bevacizumab
    Part I: Patients assigned to receive 1 of 4 dose levels of TPI 287 based on when joining the study. Phase I Starting Dose of TPI287 160 mg/m2 given by vein on Day 1 every three weeks of a 42 Day cycle. Bevacizumab given at 10 mg/kg by vein on Day 1 every 2 weeks of a 42 Day cycle. Phase II Starting Dose of TPI287: Maximum Tolerated Dose (MTD) from Phase I.
  • Experimental: Bevacizumab Group
    Phase II: Participants randomized to Arm A (bevacizumab alone at 10 mg/kg every 2 weeks) versus Arm B (bevacizumab at 10 mg/kg every 2 weeks plus TPI 287. Participant may enroll in Crossover Group to receive TPI 287 and bevacizumab if disease gets worse at any time during treatment with bevacizumab alone.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: PFS will be evaluated as a continuous variable, up to one year ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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