Sorafenib Tosylate and Temsirolimus in Treating Patients With Recurrent Glioblastoma
NCT ID: NCT00329719
Last Updated: 2018-10-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
115 participants
INTERVENTIONAL
2006-03-24
2013-02-02
Brief Summary
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Detailed Description
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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 receiving enzyme-inducing anticonvulsants (EIACs).
Phase II (closed to accrual as of 12/07/2012):
To assess the efficacy of temsirolimus and sorafenib in the treatment of recurrent glioblastoma in non-EIAC patients as measured by progression-free survival status at six months (PFS6).
Secondary Objectives -
Phase I (closed to accrual as of 01/11/2008):
I. To define the safety profile of temsirolimus and sorafenib in non-EIAC patients.
II. To assess the evidence of antitumor activity.
Phase II (closed to accrual as of 12/07/2012):
I. To assess the safety and toxicities of temsirolimus and sorafenib in the above-noted patient populations.
Outline: This is a multicenter, phase I, dose-escalation study followed by a phase II study.
Phase I (Arm A): Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (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 3 treatment groups.
Group 1 (Arm B): Patients receive sorafenib and temsirolimus as in phase I at the MTD. (patients not undergoing surgery)
Group 2 (Arm C): Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. (patients undergoing surgery) After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD.
Group 3 (Arm D): Patient receive sorafenib and temsirolimus as in phase I at the MTD. (patients who have received prior anti-vascular endothelial growth factor \[VEGF\] therapy and are not undergoing surgery)
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group I (sorafenib tosylate, temsirolimus)
Patients receive sorafenib tosylate and temsirolimus as in Phase I.
Laboratory Biomarker Analysis
Correlative studies
Sorafenib Tosylate
Given PO
Temsirolimus
Given IV
Group II (sorafenib tosylate, temsirolimus, surgery)
Patients receive sorafenib tosylate PO BID on days 1-8 and temsirolimus IV over 30 minutes on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib tosylate and temsirolimus as in Phase I.
Conventional Surgery
Undergo surgery
Laboratory Biomarker Analysis
Correlative studies
Sorafenib Tosylate
Given PO
Temsirolimus
Given IV
Group III (sorafenib tosylate, temsirolimus, anti-VEGF)
Patients who have received prior anti-VEGF therapy and are not undergoing surgery receive sorafenib tosylate and temsirolimus as in Phase I.
Laboratory Biomarker Analysis
Correlative studies
Sorafenib Tosylate
Given PO
Temsirolimus
Given IV
Interventions
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Conventional Surgery
Undergo surgery
Laboratory Biomarker Analysis
Correlative studies
Sorafenib Tosylate
Given PO
Temsirolimus
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* =\< 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Kurt Jaeckle
Role: PRINCIPAL_INVESTIGATOR
Alliance for Clinical Trials in Oncology
Locations
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Providence Alaska Medical Center
Anchorage, Alaska, United States
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
Illinois CancerCare-Macomb
Macomb, Illinois, United States
Mcdonough District Hospital
Macomb, Illinois, United States
Holy Family Medical Center
Monmouth, Illinois, United States
Illinois CancerCare-Monmouth
Monmouth, Illinois, United States
Bromenn Regional Medical Center
Normal, Illinois, United States
Community Cancer Center Foundation
Normal, Illinois, United States
Illinois CancerCare-Community Cancer Center
Normal, Illinois, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States
Illinois CancerCare-Pekin
Pekin, Illinois, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, United States
Pekin Hospital
Pekin, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Proctor Hospital
Peoria, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Illinois CancerCare-Peru
Peru, Illinois, United States
Illinois Valley Hospital
Peru, Illinois, United States
Illinois CancerCare-Princeton
Princeton, Illinois, United States
Perry Memorial Hospital
Princeton, Illinois, United States
Illinois CancerCare-Spring Valley
Spring Valley, Illinois, United States
Saint Margaret's Hospital
Spring Valley, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
The Carle Foundation Hospital
Urbana, Illinois, United States
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, United States
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States
Mercy Hospital
Cedar Rapids, Iowa, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States
Mercy Capitol
Des Moines, Iowa, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States
Iowa Lutheran Hospital
Des Moines, Iowa, United States
Mercy Medical Center - North Iowa
Mason City, Iowa, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, United States
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States
Hospital District Sixth of Harper County
Anthony, Kansas, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States
Cancer Center of Kansas-Independence
Independence, Kansas, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
Southwest Medical Center
Liberal, Kansas, United States
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States
Cancer Center of Kansas - McPherson
McPherson, Kansas, United States
Cancer Center of Kansas - Newton
Newton, Kansas, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas - Salina
Salina, Kansas, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States
Associates In Womens Health
Wichita, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States
Via Christi Regional Medical Center
Wichita, Kansas, United States
Wichita NCI Community Oncology Research Program
Wichita, Kansas, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Bronson Battle Creek
Battle Creek, Michigan, United States
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, United States
Beaumont Hospital-Dearborn
Dearborn, Michigan, United States
Saint John Hospital and Medical Center
Detroit, Michigan, United States
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, United States
Allegiance Health
Jackson, Michigan, United States
Sparrow Hospital
Lansing, Michigan, United States
Saint Mary Mercy Hospital
Livonia, Michigan, United States
Mercy Health Mercy Campus
Muskegon, Michigan, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States
Lake Huron Medical Center
Port Huron, Michigan, United States
Saint Mary's of Michigan
Saginaw, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States
Metro Health Hospital
Wyoming, Michigan, United States
Medini, Eitan MD (UIA Investigator)
Alexandria, Minnesota, United States
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Essentia Health Cancer Center
Duluth, Minnesota, United States
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, United States
Miller-Dwan Hospital
Duluth, Minnesota, United States
Fairview-Southdale Hospital
Edina, Minnesota, United States
Etzell, Paul S MD (UIA Investigator)
Fergus Falls, Minnesota, United States
Lake Region Healthcare Corporation-Cancer Care
Fergus Falls, Minnesota, United States
Swenson, Wade II, MD (UIA Investigator)
Fergus Falls, Minnesota, United States
Unity Hospital
Fridley, Minnesota, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, United States
Meeker County Memorial Hospital
Litchfield, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Minnesota Cooperative Group Outreach Program
Minneapolis, Minnesota, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
New Ulm Medical Center
New Ulm, Minnesota, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, United States
Saint Cloud Hospital
Saint Cloud, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
Saint Joseph's Hospital - Healtheast
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States
Lakeview Hospital
Stillwater, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Rice Memorial Hospital
Willmar, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, United States
Woodwinds Health Campus
Woodbury, Minnesota, United States
Nebraska Cancer Research Center
Lincoln, Nebraska, United States
Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Alegent Health Immanuel Medical Center
Omaha, Nebraska, United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, United States
Alegent Health Lakeside Hospital
Omaha, Nebraska, United States
Creighton University Medical Center
Omaha, Nebraska, United States
Rutherford Hospital
Rutherfordton, North Carolina, United States
Southeast Clinical Oncology Research (SCOR) Consortium NCORP
Winston-Salem, North Carolina, United States
Mid Dakota Clinic
Bismarck, North Dakota, United States
Saint Alexius Medical Center
Bismarck, North Dakota, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States
Roger Maris Cancer Center
Fargo, North Dakota, United States
Sanford Broadway Medical Center
Fargo, North Dakota, United States
Sanford Clinic North-Fargo
Fargo, North Dakota, United States
Altru Cancer Center
Grand Forks, North Dakota, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States
Geisinger Medical Group
State College, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States
AnMed Health Cancer Center
Anderson, South Carolina, United States
AnMed Health Hospital
Anderson, South Carolina, United States
Saint Francis Hospital
Greenville, South Carolina, United States
Spartanburg Medical Center
Spartanburg, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, United States
Medical X-Ray Center
Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, United States
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States
Bay Area Medical Center
Marinette, Wisconsin, United States
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, United States
HSHS Saint Nicholas Hospital
Sheboygan, Wisconsin, United States
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
Countries
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Other Identifiers
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NCI-2009-00652
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000472240
Identifier Type: -
Identifier Source: secondary_id
NCCTG-N0572
Identifier Type: -
Identifier Source: secondary_id
N0572
Identifier Type: OTHER
Identifier Source: secondary_id
N0572
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2009-00652
Identifier Type: -
Identifier Source: org_study_id
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