Temsirolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Completed · Phase 1

Conditions studied: Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma

In brief

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 multiforme. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving temsirolimus together with temozolomide and radiation therapy may kill more tumor cells.

Key facts

Study ID

NCT00316849

Run by

National Cancer Institute (NCI)

People needed

56

Starts

2006-05-01

Last updated by the study team

2013-04-10

Who can join

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

You may qualify if…

• 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

Where it is running

• Mayo Clinic in Florida — Jacksonville, Florida, 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 Oncology Research Association CCOP — Des Moines, Iowa, United States
• Medical Oncology and Hematology Associates-Des Moines — Des Moines, Iowa, United States
• Medical Oncology and Hematology Associates — Des Moines, Iowa, United States
• Mercy Medical Center - Des Moines — Des Moines, Iowa, United States
• Iowa Lutheran Hospital — Des Moines, Iowa, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Altru Cancer Center — Grand Forks, North Dakota, United States

Full record on ClinicalTrials.gov

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