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A Study of Temsirolimus and Bevacizumab in Recurrent Glioblastoma Multiforme

NCT00800917 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2010-06-02

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Temsirolimus

25 mg weekly IV

DRUG

Bevacizumab

10 mg/kg every 2 weeks

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER

  • Wyeth is now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • Roche, Copenhagen

    collaborator UNKNOWN

  • Rigshospitalet, Denmark

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00800917 on ClinicalTrials.gov