A Phase II Study of Temsirolimus and Bevacizumab in Recurrent Glioblastoma Multiforme

Rigshospitalet, Denmark1 site in 1 country12 target enrollmentNovember 2008

ConditionsGlioblastoma Multiforme

DrugsTemsirolimus Bevacizumab

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Glioblastoma Multiforme
Sponsor: Rigshospitalet, Denmark
Enrollment: 12
Locations: 1
Primary Endpoint: Progression-free survival in months
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

November 2008

End Date

February 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Rigshospitalet, Denmark

Eligibility Criteria

Inclusion Criteria

•Written informed consent
•Histological verification of primary GBM and failure after radiotherapy and temozolomide (TMZ)
•Previously treated with VEGF-directed therapy with bevacizumab
•Previously received radiotherapy and temozolomide
•More than 4 weeks since any of the following prior treatments: chemotherapy (6 weeks for nitrosoureas or mitomycin C)
•Radiotherapy to nontarget lesions or lesions that are not to be biopsied VEGF-directed therapy (including bevacizumab)
•Investigational agents
•More than 6 months since prior major surgery or open biopsy and recovered (only 6 weeks required if operation is for recurrent GBM)
•No concurrent medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of the following:
•Temsirolimus

Exclusion Criteria

•Clinically significant cardiovascular disease, including the following:
•Cerebrovascular accident within the past 6 months
•Transient ischemic attack within the past 6 months
•Myocardial ischemia within the past 6 months
•Myocardial infarction within the past 6 months
•Other thromboembolic event within the past 6 months
•Unstable angina within the past 6 months
•Uncontrolled hypertension (i.e., hypertension despite maximal therapy)
•New York Heart Association class II-IV heart disease
•Congestive heart failure

Outcomes

Primary Outcomes

Progression-free survival in months

Time Frame: From start of treatment to death or progression

Secondary Outcomes

Pre- vs post-treatment measurements of biomarkers and vascular system/immune system parameters(weekly for the first 4 weeks, then every 8 weeks)
Objective tumor response rate(every 8 weeks)
Correlation with biomarkers(at the end of the study)
Adverse events(every 2 weeks)