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Sorafenib and Temsirolimus in Treating Patients With Recurrent Glioblastoma

2014-08-27 03:44:27 | BioPortfolio

Summary

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temsirolimus, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib and temsirolimus may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving sorafenib together with temsirolimus may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of temsirolimus when given together with sorafenib and to see how well they work in treating patients with recurrent glioblastoma.

Description

OBJECTIVES:

Primary

- Establish a maximum tolerable dose of temsirolimus in combination with sorafenib in patients with recurrent glioblastoma not receiving enzyme-inducing anticonvulsants (EIACs). (Phase I [closed to accrual as of 11/21/07])

- Define the safety profile of temsirolimus and sorafenib in these patients. (Phase I [closed to accrual as of 11/21/07])

- Assess the evidence of antitumor activity. (Phase I [closed to accrual as of 11/21/07])

- Assess the efficacy, as measured by progression-free survival, of temsirolimus and sorafenib in patients with recurrent glioblastoma not receiving EIACs . (Phase II)

- Assess the safety and toxicities of this regimen in these patients. (Phase II)

Secondary

- Correlate tumor and blood biomarkers with clinical outcome of patients treated with temsirolimus and sorafenib.

- Evaluate tumor tissue specimens for evidence of bioactivity of these agents.

OUTLINE: This is a multicenter, phase I (closed to accrual as of 11/21/07), dose-escalation study of temsirolimus followed by a phase II open-label study.

- Phase I (closed to accrual as of 11/21/07): Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

- Phase II: Patients are assigned to 1 of 2 treatment groups.

- Group 1 (patients not undergoing surgery): Patients receive sorafenib and temsirolimus as in phase I (closed to accrual as of 11/21/07) at the MTD.

- Group 2 (patients undergoing surgery): Patients receive oral sorafenib twice daily on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I (closed to accrual as of 11/21/07) at the MTD.

- Group 3 (patients who have received prior anti-VEGF therapy and are not undergoing surgery): Patient receive sorafenib and temsirolimus as in phase I (closed to accrual as of 11/21/07) at the MTD.

Biopsy or resected tissue and blood are collected prior to treatment (usually at diagnosis) and analyzed for biomarkers.

After completion of study treatment, patients are followed every 6 months for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 141 patients will be accrued for this study.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Brain and Central Nervous System Tumors

Intervention

sorafenib tosylate, temsirolimus

Location

Mayo Clinic Scottsdale
Scottsdale
Arizona
United States
85259-5499

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:44:27-0400

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Neoplasms of the intracranial components of the central nervous system, including the cerebral hemispheres, basal ganglia, hypothalamus, thalamus, brain stem, and cerebellum. Brain neoplasms are subdivided into primary (originating from brain tissue) and secondary (i.e., metastatic) forms. Primary neoplasms are subdivided into benign and malignant forms. In general, brain tumors may also be classified by age of onset, histologic type, or presenting location in the brain.

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