Status:
COMPLETED
Sorafenib Tosylate and Temsirolimus in Treating Patients With Recurrent Glioblastoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Glioblastoma
Adult Gliosarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 c...
Detailed Description
Primary Objective - Phase I (closed to accrual as of 01/11/2008): To establish a maximum tolerable dose of temsirolimus in combination with sorafenib in patients with recurrent glioblastoma not rece...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
March 24 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2013
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00329719
Start Date
March 24 2006
End Date
February 2 2013
Last Update
October 16 2018
Active Locations (190)
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1
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
2
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
3
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States, 06105
4
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980