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

Completed · Phase 1/Phase 2

Conditions studied: Brain and Central Nervous System Tumors

In brief

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking some of the blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving everolimus together with temozolomide and radiation therapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus when given together with temozolomide and radiation therapy in treating patients with newly diagnosed glioblastoma.

Key facts

Study ID

NCT00553150

Run by

Alliance for Clinical Trials in Oncology

People needed

122

Starts

2009-03-01

Expected to finish

2019-11-15

Last updated by the study team

2020-02-13

Who can join

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

You may qualify if…

• ECOG performance status 0-2
• ANC ≥ 1,500/μL
• Hemoglobin ≥ 9.0 g/dL
• Platelet count ≥ 100,000/μL
• Total bilirubin ≤ 2.5 x institutional upper limit of normal (ULN)
• Serum total cholesterol < 350 mg/dL
• Serum total triglycerides < 400 mg/dL
• AST ≤ 2.5 x ULN
• Creatinine ≤ 1.5 x ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 60 days after completion of study therapy
• Must be willing to undergo 2 mandatory research PET or PET/CT scans (all MCR and MCJ patients in phase I and MCR only patients in phase II)
• Must be willing to abstain from eating or drinking grapefruit or grapefruit juice during study treatment
• Must be willing to follow a diet low in fat and cholesterol while taking everolimus
• Must be willing to have imaging scans submitted for central review
• Ability to understand and willingness to sign a written informed consent

You may not qualify if…

• Other active cancers requiring therapy to control disease or prior cancer diagnoses which pose a greater than 30% risk of death within the next 2 years
• Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active uncontrolled peptic ulcer disease
• Uncontrolled intercurrent illness including, but not limited to, any of the following:
• Ongoing, uncontrolled, or active (acute or chronic) infection or disorder
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Cardiac arrhythmia
• Psychiatric illness/social situations that would limit compliance with study requirements
• Severely impaired lung function
• Uncontrolled diabetes (fasting serum glucose > 2 x ULN) OR diabetes that would interfere with the performance of the FDG-PET/CT or FDG-PET scans
• Liver disease (e.g., cirrhosis, chronic active hepatitis, chronic persistent hepatitis, or history of hepatitis B)
• Known HIV positivity
• Positive hepatitis B antigen (HBsAg) or hepatitis C serology (HCV) tests
• Any history of allergy or intolerance to dacarbazine (DTIC)
• Significant traumatic injury within the past 21 days
• Severe allergy to sulfa medications
• Inability to tolerate levofloxacin with dapsone or pentamidine (inhaled or IV)
• PRIOR CONCURRENT THERAPY:
• Inclusion criteria:
• At least 1 week, but no more than 6 weeks since prior surgical resection or biopsy
• Must comply with antibiotic prophylaxis with either trimethoprim/sulfamethoxazole (daily or 3 times per week), oral dapsone (daily) combined with daily levofloxacin, or monthly pentamidine (inhaled or IV) combined with daily levofloxacin
• Exclusion criteria:
• Prior chemotherapy for any brain tumor
• Prior temozolomide or mTOR inhibitor therapies
• Any prior cranial radiotherapy

Where it is running

• Illinois CancerCare - Kewanee Clinic — Kewanee, Illinois, United States
• Illinois CancerCare - Macomb — Macomb, Illinois, United States
• McDonough District Hospital — Macomb, Illinois, United States
• Trinity Cancer Center at Trinity Medical Center - 7th Street Campus — Moline, Illinois, United States
• Study site — Moline, Illinois, United States
• Illinois CancerCare - Monmouth — Monmouth, Illinois, United States
• OSF Holy Family Medical Center — Monmouth, Illinois, United States
• BroMenn Regional Medical Center — Normal, Illinois, United States
• Community Cancer Center — Normal, Illinois, United States
• Illinois CancerCare - Community Cancer Center — Normal, Illinois, United States
• Community Hospital of Ottawa — Ottawa, Illinois, United States
• Oncology Hematology Associates of Central Illinois, PC - Ottawa — Ottawa, Illinois, United States
• Cancer Treatment Center at Pekin Hospital — Pekin, Illinois, United States
• Illinois CancerCare - Pekin — Pekin, Illinois, United States
• CCOP - Illinois Oncology Research Association — Peoria, Illinois, United States
• Oncology Hematology Associates of Central Illinois, PC - Peoria — Peoria, Illinois, United States
• Methodist Medical Center of Illinois — Peoria, Illinois, United States
• OSF St. Francis Medical Center — Peoria, Illinois, United States
• Illinois CancerCare - Peru — Peru, Illinois, United States
• Illinois Valley Community 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
• St. Francis Hospital and Health Centers - Beech Grove Campus — Beech Grove, Indiana, United States
• Mason District Hospital — Havana, Illinois, United States

Full record on ClinicalTrials.gov

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