Ph II Cilengitide Plus Bevacizumab for Recurrent Glioblastoma (GBM)

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01782976
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Cilengitide — DRUG
    2000 mg by vein twice weekly of each 28 day cycle.
  • Bevacizumab — DRUG
    10 mg/kg by vein on Days 1 and 15 of each 28 day cycle.
  • Questionnaire — BEHAVIORAL
    Completion of MD Anderson Symptom Inventory for Brain Tumors (MDASI-BT) at baseline, Day 1 of cycle 2, and at end of treatment visit. Questionnaire should take about 5 minutes to complete.

Study Details

The goal of this clinical research study is to learn if cilengitide given in combination with bevacizumab can help to control glioblastoma. The safety of this drug combination will also be studied. Cilengitide is designed to block the flow of blood to cancer cells, which may help to slow or block the growth of cancer. Bevacizumab is designed to block the growth of new blood vessels, which may help to slow or block the growth of cancer.

Key Dates

First listed
Feb 4, 2013
Start date
Jun 30, 2013
Status verified
Jan 2018
Primary completion
Jun 30, 2017

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cilengitide + Bevacizumab
    Cilengitide administered intravenously at 2000 mg twice weekly, while Bevacizumab administered intravenously at 10 mg/kg every other week. Each cycle of therapy will be 4 weeks long.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: 6 months ]

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