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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)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (11 locations)

    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