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Sorafenib Tosylate and Temsirolimus in Treating Patients With Recurrent Glioblastoma

NCT00329719 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2018-10-16

Study results available
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Summary

This phase I/II trial studies the side effects and best dose of temsirolimus when given together with sorafenib tosylate and to see how well they work in treating patients with glioblastoma that has come back. Sorafenib tosylate 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 tosylate and temsirolimus may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving sorafenib tosylate with temsirolimus may kill more tumor cells.

Conditions

  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Recurrent Adult Brain Neoplasm

Interventions

PROCEDURE

Conventional Surgery

Undergo surgery

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Sorafenib Tosylate

Given PO

DRUG

Temsirolimus

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Kurt Jaeckle · Alliance for Clinical Trials in Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-24
Primary Completion
2013-02-01
Completion
2013-02-02

Countries

  • United States

Study Locations

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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 NCT00329719 on ClinicalTrials.gov