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Tipifarnib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

Phase I Trial of R115777 With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme

NCT02227901•National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This phase I trial studies the side effects and best dose of tipifarnib when given together with radiation therapy and temozolomide in treating patients with newly diagnosed glioblastoma multiforme. Tipifarnib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving tipifarnib together with radiation therapy and temozolomide may be a better way to treat glioblastoma multiforme.

Detailed Description

PRIMARY OBJECTIVES: I. Establish maximum tolerated dose (MTD) for tipifarnib (R115777) in combination with temozolomide with radiation in patients not on enzyme-inducing anti-epileptic drugs (EIAEDs). II. To define the safety of R115777 in combination with temozolomide with radiation in this patient population. III. To assess for evidence of antitumor activity in this patient population. OUTLINE: This is a dose-escalation study of tipifarnib. TIPIFARNIB: Patients receive tipifarnib orally (PO) twice daily (BID) on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. CONCURRENT CHEMOTHERAPY DURING RADIATION THERAPY: Within 5-9 days after starting tipifarnib, patients undergo external beam radiation therapy (EBRT) daily and receive temozolomide PO daily for 6 weeks. POST-RADIATION CHEMOTHERAPY: Beginning at week 10 post-radiation therapy, patients receive temozolomide PO on days 1-5. Treatment repeats every 28 days for 1 year or 12 complete courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 4 months.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients will have histologically proven intracranial glioblastoma multiforme (GBM) or gliosarcoma (GS)
•Diagnosis will have been established by biopsy or resection within 4 weeks prior to registration
•Patients must not have received previous radiotherapy to the brain
•Patients must not have received cytotoxic drug therapy, non-cytotoxic drug therapy, or experimental drug therapy directed against the brain tumor; patients who received Gliadel wafers will be excluded; patients may have received or be receiving corticosteroids, non-EIAEDs, analgesics, and other drugs to treat symptoms or prevent complications
•Cranial magnetic resonance imaging (MRI) or contrast computed tomography (CT) must have been performed within 21days of study entry; the use of MRI rather than CT is preferred; the same type of scan, i.e., MRI or CT must be used throughout the period of protocol treatment for tumor measurement; if the surgical procedure was a resection, cranial MRI or contrast CT performed with 96 hours of resection is preferred but not required; patients without measurable or assessable disease are eligible
•Patients must have a plan to begin partial brain radiotherapy within 5-9 days after beginning R115777, and within 35 days (5 weeks) of the surgical procedure that established the diagnosis; radiotherapy must be given at the Radiation Oncology Department of the registering Adult Brain Tumor Consortium (ABTC) institution; radiotherapy must be given by external beam to a partial brain field in daily fractions of 2.0 Gray (Gy), to a planned total dose to the tumor of 60.0 Gy; stereotactic radiosurgery and brachytherapy will not be allowed
•Patients must be willing to forego other drug therapy against the tumor while being treated with R115777 and temozolomide
•All patients must sign an informed consent indicating that they are aware of the investigational nature of this study; patients must sign an authorization for the release of their protected health information; patients must be registered with the Adult Brain Tumor Consortium Central Office (ABTC CO) prior to treatment with study drug
•A life expectancy \> 8 weeks
•Patients must have a Karnofsky performance status of \>= 60
+15 more criteria

Locations (1)

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Key Dates

Start Date

September 1, 2002

Primary Completion Date

June 1, 2007

Completion Date

April 1, 2014

Last Updated

December 23, 2014

Enrollment

ACTUAL participants

Conditions

Adult Giant Cell GlioblastomaAdult GlioblastomaAdult Gliosarcoma

Interventions

Tipifarnib

DRUG

External Beam Radiation Therapy

RADIATION

Temozolomide

DRUG

Laboratory Biomarker Analysis

OTHER

Advanced MR Imaging as Predictor of Treatment Response in Newly Diagnosed Glioblastomas

NCT02613988

Adult Glioblastoma

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COMPLETEDPHASE2

NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma

NCT01894061

Adult Giant Cell GlioblastomaAdult Glioblastoma+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 23, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Advanced MR Imaging as Predictor of Treatment Response in Newly Diagnosed Glioblastomas

NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma

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