Sorafenib Tosylate and Temsirolimus in Treating Patients With Recurrent Glioblastoma

Completed · Phase 1/Phase 2

Conditions studied: Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Neoplasm

In brief

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.

Key facts

Study ID

NCT00329719

Run by

National Cancer Institute (NCI)

People needed

115

Starts

2006-03-24

Expected to finish

2013-02-02

Last updated by the study team

2018-10-16

Who can join

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

You may qualify if…

• Central pathology review submission; this review is mandatory prior to registration to confirm eligibility; it should be initiated as soon after surgery as possible
• =< 2 prior systemic chemotherapy regimens
• Histological confirmation of a grade 4 astrocytoma (glioblastoma) or gliosarcoma, at primary diagnosis or recurrence by World Health Organization (WHO) criteria; central pathology review is mandatory prior to study entry to confirm eligibility
• Evidence of tumor progression by magnetic resonance imaging (MRI) or computed tomography (CT) scan following radiation therapy (RT) or following the most recent anti-tumor therapy
• Bidimensionally measurable or evaluable disease by MRI or CT scan
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
• >= 12 weeks since the completion of RT
• Fixed or decreasing dose of corticosteroids (or no corticosteroids) >= 1 week prior to registration
• >= 1 week from minor surgery other than venous line placement and > 3 weeks from major surgery (except for patients undergoing tumor tissue acquisition)
• >= 4 weeks since prior cytotoxic chemotherapy (>= 6 weeks for nitrosoureas)
• >= 2 weeks from cytostatic chemotherapy such as tamoxifen, cis-retinoic acid, or thalidomide (address questions regarding such agents to study chair)
• White blood cells (WBC) >= 3,000/mm\^3
• Absolute neutrophil count (ANC) >= 1,500/mm\^3
• Platelet count >= 100,000/mm\^3
• Hemoglobin (Hgb) >= 10 gm/dL
• Total bilirubin =< 1.5 x upper limit of normal (ULN)
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 2.5 x ULN
• Creatinine =< 2.0 x ULN
• Serum cholesterol =< 350 mg/dL
• Serum triglycerides =< 400 mg/dL
• Willingness to provide the biologic specimens as required by the protocol; (please note that the willingness to participate pertains only to the patient and does not factor in the institution?s ability to participate in any part of the translational component)

You may not qualify if…

• Prior intratumoral chemotherapy (e.g., Gliadel or IL13-PE38QQR), stereotactic radiosurgery, or interstitial brachytherapy unless there is a separate lesion on MRI which is not part of the previous treatment field or there is proof of recurrent disease based on biopsy, MRI spectroscopy, or positron emission tomography (PET) scan
• Prior CCI-779, sorafenib, or other agents specifically targeting mammalian target of rapamycin (mTOR) or raf; patients receiving prior agents inhibiting VEGF or VEGF receptor (R) (prior anti-VEGF group) are eligible but: 1) must be at least four weeks from last treatment with the agent(s); and 2) must have recovered from any clinically relevant toxicities attributable to this agent(s)
• Evidence of bleeding diathesis or coagulopathy
• Note: Patients on prophylactic anticoagulation therapy (e.g., low-dose warfarin) are eligible provided their coagulation parameter levels are as follows: prothrombin time (International Normalized Ratio [INR] of prothrombin time) < 1.1 x institutional upper limit of normal
• Note: Patients on full-dose anticoagulants (e.g., warfarin) are eligible provided that both of the following criteria are met: a) the patient has an in-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin, and b) the patient has no active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
• International normalized ration (INR) > 1.5 (unless the patient is on full-dose warfarin)
• Receiving enzyme-inducing antiepileptic drugs (EIAEDs; e.g., phenytoin, fosphenytoin, carbamazepine, phenobarbital, or primidone) or any other potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducer, such as rifampin or St. John?s wort
• Any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow pills
• Hypertension with systolic blood pressure of > 140 mmHg or diastolic pressure > 90 mmHg; however, patients with well-controlled hypertension are eligible
• Uncontrolled infection
• Pregnant women
• Nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Known hypersensitivity to any of the components of CCI-779 or sorafenib
• Other active malignancy
• Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness/social situation that would preclude study compliance with study requirements
• Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive; HIV-positive patients on combination antiretroviral therapy are ineligible
• Receiving any investigational agents other than CCI-779 and sorafenib
• Significant intratumoral, intracerebral, or subarachnoid hemorrhage on baseline MRI or CT, or other history of significant intratumoral, intracerebral, or subarachnoid hemorrhage

Where it is running

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Smilow Cancer Hospital Care Center at Saint Francis — Hartford, Connecticut, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• Saint Alphonsus Cancer Care Center-Boise — Boise, Idaho, United States
• Rush - Copley Medical Center — Aurora, Illinois, United States
• Saint Joseph Medical Center — Bloomington, Illinois, United States
• Illinois CancerCare-Bloomington — Bloomington, Illinois, United States
• Graham Hospital Association — Canton, Illinois, United States
• Illinois CancerCare-Canton — Canton, Illinois, United States
• Illinois CancerCare-Carthage — Carthage, Illinois, United States
• Memorial Hospital — Carthage, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Heartland Cancer Research NCORP — Decatur, Illinois, United States
• Saint Anthony Memorial Hospital — Effingham, Illinois, United States
• Eureka Hospital — Eureka, Illinois, United States
• Illinois CancerCare-Eureka — Eureka, Illinois, United States
• Galesburg Cottage Hospital — Galesburg, Illinois, United States
• Illinois CancerCare-Galesburg — Galesburg, Illinois, United States
• Illinois CancerCare-Havana — Havana, Illinois, United States
• Mason District Hospital — Havana, Illinois, United States
• Hopedale Medical Complex - Hospital — Hopedale, Illinois, United States
• Joliet Oncology-Hematology Associates Limited — Joliet, Illinois, United States
• Illinois CancerCare-Kewanee Clinic — Kewanee, Illinois, United States
• Kewanee Hospital — Kewanee, Illinois, United States
• Providence Alaska Medical Center — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.