A Study of Temsirolimus and Bevacizumab in Recurrent Glioblastoma Multiforme

Sponsor
Rigshospitalet, Denmark
Study ID
NCT00800917
Phase
PHASE2
Status
Completed

Conditions

  • Glioblastoma Multiforme

Eligibility Criteria

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

Interventions

  • Temsirolimus — DRUG
    25 mg weekly IV
  • Bevacizumab — DRUG
    10 mg/kg every 2 weeks

Study Details

This trial is an investigator initiated, open label phase II study, where patient with recurrent primary GBM will be considered for the study. Only patients with recurrence after Temozolomide and VEGF-directed therapy with Bevacizumab will be considered for the study. Patients will receive temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15 and 22 and bevacizumab 10 mg/kg IV over 30-90 minutes on day 8 and 22. Treatment repeats every 28 days for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity. A safety analysis will be performed when the first 10 patients have received minimum 4 cycles (8 weeks). The study will then be stopped: If DLT is observed in \> 2/10 patients, Occurrence of any serious adverse events not described in the SPC of each agents, If partial remission is not observed in at least 1/10 patients

Key Dates

First listed
Dec 2, 2008
Start date
Nov 30, 2008
Status verified
Apr 2010
Primary completion
Feb 28, 2010
Completion
Feb 28, 2010

Study Design

Enrollment
12 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Progression-free survival in months [ Time Frame: From start of treatment to death or progression ]

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