Sorafenib Combined With Erlotinib, Tipifarnib, or Temsirolimus in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma

Completed · Phase 1/Phase 2

Conditions studied: Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor

In brief

This phase I/II trial is studying the side effects and best dose of erlotinib, tipifarnib, and temsirolimus when given together with sorafenib and to see how well they work in treating patients with recurrent glioblastoma multiforme or gliosarcoma. Sorafenib, erlotinib, tipifarnib, and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib and tipifarnib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib together with erlotinib, tipifarnib, or temsirolimus may kill more tumor cells.

Key facts

Study ID

NCT00335764

Run by

National Cancer Institute (NCI)

People needed

92

Starts

2006-04-01

Expected to finish

2012-09-01

Last updated by the study team

2018-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed intracranial glioblastoma multiforme or gliosarcoma
• Evidence of tumor progression by MRI or CT scan within the past 14 days AND on a steroid dose that has been stable for ≥ 5 days
• Patients who underwent prior therapy that included interstitial brachytherapy or stereotactic radiosurgery must have confirmation of true progressive disease rather than radiation necrosis by either positron emission tomography or thallium scanning, magnetic resonance (MR) spectroscopy, or surgical documentation of disease
• Recent resection of recurrent or progressive tumor allowed
• Residual disease is not required
• Treatment for any number of prior relapses, defined as disease progression after initial therapy (i.e., radiotherapy with or without chemotherapy if used as initial treatment), allowed (phase I)
• No more than 3 prior therapies (initial therapy and therapy for 2 relapses) (phase II)
• Each of the following is considered 1 relapse:
• Disease progression after initial therapy (i.e., radiotherapy with or without chemotherapy if used as initial therapy)
• Underwent a surgical resection for relapsed disease and received no anticancer therapy for up to 12 weeks after surgical resection AND then underwent a subsequent surgical resection
• Received prior therapy for a low-grade glioma, followed by a surgical diagnosis of glioblastoma
• Failed prior radiotherapy
• 15 unstained paraffin slides or 1 tissue block must be available from original surgery, definitive surgery, or surgery closest to the initiation of this study (phase II)
• Karnofsky performance status 60-100%
• White Blood Cell (WBC) ≥ 3,000/mm\^3
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hemoglobin ≥ 10 g/dL (transfusion allowed)
• Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT) ≤ 2.5 times upper limit of normal (ULN)
• Total bilirubin normal
• Creatinine < 1.5 mg/dL
• Prothrombin time (PT)/ international normalized ratio (INR) ≤ 1.5 (INR < 3.0 for patients on anticoagulation therapy)
• INR < 1.1 times upper limit of normal (ULN) (for patients on prophylactic anticoagulation therapy [low-dose warfarin])
• Fasting cholesterol < 350 mg/dL (for patients receiving temsirolimus and sorafenib)
• Fasting triglycerides < 400 mg/dL (for patients receiving temsirolimus and sorafenib)

Where it is running

• University of California at Los Angeles — Los Angeles, California, United States
• University of California San Francisco — San Francisco, California, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• M D Anderson Cancer Center — Houston, Texas, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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