Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01062399 : Everolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: N/A
Eligibility
DISEASE CHARACTERISTICS:

- Histologically confirmed glioblastoma multiforme (GBM) (WHO grade IV) by central
pathology review

- Gliosarcoma allowed

- Tumor must have a supratentorial component

- Diagnosis must have been made by surgical excision, either partial or complete
excision, within the past 5 weeks

- Stereotactic biopsy or Cavitron ultrasonic aspirator-derived tissue are not
allowed

- Tumor tissue available for correlative studies (phase II only)

- Patients must have ? 1 block of tissue; if a block cannot be submitted, two
tissue specimens punched with a skin punch (2 mm diameter) from the tissue block
containing the tumor may be submitted

- No recurrent or multifocal malignant glioma

- No metastases detected below the tentorium or beyond the cranial vault

PATIENT CHARACTERISTICS:

- Karnofsky performance status 70-100%

- ANC ? 1,800/mm^3

- Platelet count ? 100,000/mm^3

- Hemoglobin ? 10.0 g/dL (transfusion or other intervention allowed)

- PT/INR ? 1.5

- BUN ? 30 mg/dL

- Serum creatinine ? 1.5 times upper limit of normal (ULN)

- Bilirubin ? 1.5 times normal

- ALT and AST ? 2.5 times normal

- Fasting serum cholesterol ? 300 mg/dL OR ? 7.75 mmol/L AND fasting triglycerides ?
2.5 times ULN (if one or both of these thresholds are exceeded, patients are eligible
only after initiation of appropriate lipid-lowering medication)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other invasive malignancy within the past 3 years except for nonmelanoma skin
cancer or carcinoma in situ of the breast, oral cavity, or cervix

- No severe, active co-morbidity, defined as follows:

- NYHA class III-IV symptomatic congestive heart failure

- Unstable angina pectoris, symptomatic congestive heart failure, myocardial
infarction within the past 6 months, serious uncontrolled cardiac arrhythmia, or
any other clinically significant cardiac disease

- Severely impaired lung function, defined as spirometry and DLCO that is 50% of
the normal predicted value and/or oxygen saturation that is ? 88% at rest on
room air

- Uncontrolled diabetes, defined as fasting serum glucose > 1.5 times ULN

- Active (acute or chronic) or uncontrolled severe infections requiring IV
antibiotics

- Liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent
hepatitis

- AIDS based upon current Centers for Disease Control and Prevention definition or
known HIV seropositivity (HIV testing is not required for study entry)

- Active connective tissue disorders such as lupus erythematosus or scleroderma
that, in the opinion of the treating physician, may put the patient at high risk
for radiation toxicity

- Other major medical illness or psychiatric impairment that, in the
investigator's opinion, will prevent administration or completion of study
treatment

- No impaired gastrointestinal (GI) function or GI disease that may significantly alter
the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea,
vomiting, diarrhea, malabsorption syndrome, or small bowel resection)

- No history of deep vein thrombosis or pulmonary embolism

- No prior allergic reaction to temozolomide

- No known hypersensitivity to mTOR inhibitors (e.g., sirolimus, temsirolimus,
everolimus) or to their excipients

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Recovered from the effects of surgery, postoperative infection, and other
complications

- No prior temozolomide

- No prior mTOR inhibitor (e.g., sirolimus, temsirolimus, everolimus)

- No prior Gliadel wafers or any other intratumoral or intracavitary treatment

- No prior radiotherapy to the head or neck (except for T1 glottic cancer) resulting in
overlap of radiotherapy fields

- No prior chemotherapy or radiosensitizers for cancer of the head and neck region

- Prior chemotherapy for a different cancer is allowed

- No prior radiotherapy or chemotherapy for GBM

- No prior or concurrent treatment on any other therapeutic clinical study

- At least 14 days since prior and no concurrent enzyme-inducing anti-epileptic drugs

- Concurrent anticoagulation allowed provided target INR ? 1.5 AND patient is on a
stable dose of warfarin or low molecular weight heparin for > 2 weeks
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT01062399      |      Link to official Clinicaltrials.gov listing
Locations
Ottawa, Ontario
Canada

Facility: Ottawa Hospital Regional Cancer Centre - General Campus
Investigator:
Contact: Shawn C. Malone Phone: 613-737-7700 ext. 70209
Email not avaialable

Tel Aviv,
Israel

Facility: Tel-Aviv Sourasky Medical Center
Investigator:
Contact: Deborah T. Blumenthal Phone: 972-3-697-4444
Email not avaialable

Newark, Delaware
Facility: CCOP - Christiana Care Health Services
Investigator:
Contact: Clinical Trial Office - CCOP - Christiana Care Health Services Phone: 302-623-4450
Email not avaialable

Gainesville, Florida
Facility: University of Florida Shands Cancer Center
Investigator:
Contact: Clinical Trials Office - University of Florida Shands Cancer C Phone: 888-254-7581
Email not avaialable

Jacksonville, Florida
Facility: Integrated Community Oncology Network at Southside Cancer Center
Investigator:
Contact: Douglas W. Johnson, MD Phone: 904-202-2273
Email not avaialable

Jacksonville, Florida
Facility: Baptist Cancer Institute - Jacksonville
Investigator:
Contact: Clinical Trials Office - Baptist Cancer Institute - Jacksonvil Phone: 904-202-7051
Email not avaialable

Jacksonville Beach, Florida
Facility: Integrated Community Oncology Network
Investigator:
Contact: Douglas W. Johnson, MD Phone: 904-202-2273
Email not avaialable

Jascksonville, Florida
Facility: Baptist Medical Center South
Investigator:
Contact: Douglas W. Johnson, MD Phone: 904-202-2273
Email not avaialable

Orange Park, Florida
Facility: Integrated Community Oncology Network - Orange Park
Investigator:
Contact: Douglas W. Johnson, MD Phone: 904-202-2273
Email not avaialable

Palatka, Florida
Facility: Florida Cancer Center - Palatka
Investigator:
Contact: Douglas W. Johnson, MD Phone: 904-202-2273
Email not avaialable

Saint Augustine, Florida
Facility: Flagler Cancer Center
Investigator:
Contact: Douglas W. Johnson, MD Phone: 904-202-2273
Email not avaialable

Tampa, Florida
Facility: H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Investigator:
Contact: Clinical Trials Office - H. Lee Moffitt Cancer Center and Rese Phone: 800-456-7121
Click HERE to send email to this center

Atlanta, Georgia
Facility: Winship Cancer Institute of Emory University
Investigator:
Contact: Clinical Trials Office - Winship Cancer Institute Phone: 404-778-1900
Email not avaialable

Indianapolis, Indiana
Facility: St. Vincent Oncology Center
Investigator:
Contact: Robert H. Liebross Phone: 317-415-6789
Email not avaialable

Baltimore, Maryland
Facility: St. Agnes Hospital Cancer Center
Investigator:
Contact: Richard S. Hudes, MD Phone: 410-368-2965
Email not avaialable

Boston, Massachusetts
Facility: Dana-Farber/Brigham and Women's Cancer Center
Investigator:
Contact: Clinical Trials Office Phone: 617-724-5200
Email not avaialable

Pascagoula, Mississippi
Facility: Regional Cancer Center at Singing River Hospital
Investigator:
Contact: James E. Clarkson, MD Phone: 228-374-6296
Email not avaialable

Livingston, New Jersey
Facility: St. Barnabas Medical Center Cancer Center
Investigator:
Contact: Clinical Trials Office - St. Barnabas Medical Center Cancer Ce Phone: 973-322-2470
Email not avaialable

Albany, New York
Facility: New York Oncology Hematology, PC at Albany Regional Cancer Care
Investigator:
Contact: Merideth M.M. Wendland Phone: 518-489-2607
Email not avaialable

Rochester, New York
Facility: James P. Wilmot Cancer Center at University of Rochester Medical Center
Investigator:
Contact: Yuhchyau Chen Phone: 585-275-5345
Email not avaialable

Rochester, New York
Facility: University Radiation Oncology at Parkridge Hospital
Investigator:
Contact: Yuhchyau Chen Phone: 585-225-3989
Email not avaialable

Charlotte, North Carolina
Facility: Blumenthal Cancer Center at Carolinas Medical Center
Investigator:
Contact: Clinical Trials Office - Blumenthal Cancer Center at Carolinas Phone: 704-355-2884
Email not avaialable

Akron, Ohio
Facility: Summa Center for Cancer Care at Akron City Hospital
Investigator:
Contact: Clinical Trials Office - Akron City Hospital Phone: 330-375-6101
Email not avaialable

Barberton, Ohio
Facility: Barberton Citizens Hospital
Investigator:
Contact: William F. Demas, MD Phone: 330-375-3557
Email not avaialable

Cleveland, Ohio
Facility: Cleveland Clinic Taussig Cancer Center
Investigator:
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente Phone: 866-223-8100
Email not avaialable

Eugene, Oregon
Facility: Willamette Valley Cancer Center - Eugene
Investigator:
Contact: Merideth M.M. Wendland Phone: 541-683-5001
Email not avaialable

Gettysburg, Pennsylvania
Facility: Adams Cancer Center
Investigator:
Contact: Amit B. Shah Phone: 717-741-8180
Email not avaialable

Hanover, Pennsylvania
Facility: Cherry Tree Cancer Center
Investigator:
Contact: Amit B. Shah Phone: 717-741-8180
Email not avaialable

Reading, Pennsylvania
Facility: McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Investigator:
Contact: Clinical Trials Office - McGlinn Family Regional Cancer Center Phone: 610-988-9323
Email not avaialable

York, Pennsylvania
Facility: York Cancer Center at Apple Hill Medical Center
Investigator:
Contact: Amit B. Shah Phone: 717-741-8180
Email not avaialable

Providence, Rhode Island
Facility: Rhode Island Hospital Comprehensive Cancer Center
Investigator:
Contact: Clinical Trials Office - Rhode Island Hospital Comprehensive C Phone: 401-444-1488
Email not avaialable

San Antonio, Texas
Facility: University of Texas Health Science Center at San Antonio
Investigator:
Contact: Richard L. Crownover Phone: 210-567-4777
Email not avaialable

Tyler, Texas
Facility: Tyler Cancer Center
Investigator:
Contact: Merideth M.M. Wendland Phone: 903-579-9800
Email not avaialable

Salt Lake City, Utah
Facility: Huntsman Cancer Institute at University of Utah
Investigator:
Contact: Clinical Trials Office - Huntsman Cancer Institute at Universi Phone: 801-581-4477
Click HERE to send email to this center

Milwaukee, Wisconsin
Facility: Medical College of Wisconsin Cancer Center
Investigator:
Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C Phone: 414-805-4380
Email not avaialable

Waukesha, Wisconsin
Facility: Waukesha Memorial Hospital Regional Cancer Center
Investigator:
Contact: Clinical Trials Office - Waukesha Memorial Hospital Regional C Phone: 262-928-7632
Email not avaialable




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