Status:
COMPLETED
Temsirolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects and best dose of temsirolimus when given together with temozolomide and radiation therapy in treating patients with newly diagnosed glioblastoma multifo...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of temsirolimus when administered with temozolomide in combination with radiotherapy followed by adjuvant temozolomide in patients with new...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed glioblastoma multiforme (GBM)
- Gliosarcoma and other grade 4 astrocytoma variants (e.g., giant cell glioblastoma) allowed
- Newly diagnosed disease
- Has undergone surgical resection or biopsy of the tumor at least 1 week but no more than 6 weeks ago
- ECOG performance status 0-2
- Absolute neutrophil count ≥ 1,500/mm\^3
- Hemoglobin ≥ 9.0 g/dL
- Platelet count ≥ 100,000/mm\^3
- Total bilirubin ≤ 2.5 times upper limit of normal (ULN)
- Cholesterol \< 350 mg/dL
- Triglycerides \< 400 mg/dL
- AST ≤ 2.5 times ULN
- Creatinine ≤ 1.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of allergy or intolerance to dacarbazine
- No ongoing or active infection
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled illness
- No gastrointestinal tract disease affecting ability to take oral medication or requiring IV alimentation
- No significant traumatic injury within the past 21 days
- No active, uncontrolled peptic ulcer disease
- No other active cancers requiring therapy
- No concurrent combination antiretroviral therapy for HIV-positive patients
- Willing and able to comply with antibiotic prophylaxis with either trimethoprim/sulfamethoxazole (daily or 3 times per week) or monthly IV pentamidine combined with daily levofloxacin
- No prior chemotherapy for any brain tumor
- No prior temozolomide or mTOR inhibitor therapies
- No prior cranial radiotherapy
- More than 21 days since prior major surgery (excluding neurosurgical biopsy or resection of GBM)
- No prior surgical procedures affecting absorption
- No concurrent enzyme-inducing anticonvulsants, including any of the following:
- Carbamazepine
- Phenytoin
- Phenobarbital
- Primidone
- No other concurrent investigational agents
- Not receiving warfarin prior to study registration
- Concurrent warfarin allowed if patients develop an indication for it while enrolled on the protocol
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00316849
Start Date
May 1 2006
Last Update
April 10 2013
Active Locations (11)
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1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
2
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States, 50325
3
Mercy Capitol
Des Moines, Iowa, United States, 50307
4
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309