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

NCT00049387 | Completed Phase 1

• 5 other identifiers: NCI-2012-03106NCI-03-C-0189NABTC-0202NABTC-02-02U01CA062399
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial is studying the side effects and best dose of tipifarnib when given together with temozolomide and radiation therapy in treating patients with newly diagnosed glioblastoma multiforme or gliosarcoma. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor 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 damage tumor cells. Combining tipifarnib, temozolomide, and radiation therapy may kill more tumor cells.

Conditions

Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma

Outcome Measures

Primary Outcomes (3)

• MTD of tipifarnib

  Safety variables will be summarized by descriptive statistics. Adverse events that occur will be reported for each dose level and described in terms of incidence and severity. Laboratory data will be presented by dose level at each observation time. Values outside of normal limits will be identified and their frequency calculated. Parameters will be described based on the CTCAE severity grading. Distribution by CTCAE severity grade (when applicable) and clinical relevance will be given.

  Week 10

• Incidence of adverse events

  Safety variables will be summarized by descriptive statistics. Adverse events that occur will be reported for each dose level and described in terms of incidence and severity. Laboratory data will be presented by dose level at each observation time. Values outside of normal limits will be identified and their frequency calculated. Parameters will be described based on the CTCAE severity grading. Distribution by CTCAE severity grade (when applicable) and clinical relevance will be given.

  Up to 5 years

• Antitumor activity

  Up to 5 years

Study Arms (1)

Treatment (tipifarnib, temozolomide, radiation therapy)

EXPERIMENTAL

See Detailed Description

Drug: tipifarnib; Drug: temozolomide; Radiation: radiation therapy

Interventions

tipifarnib DRUG

Given PO

Also known as: R115777, Zarnestra

Treatment (tipifarnib, temozolomide, radiation therapy)

temozolomide DRUG

Given PO

Also known as: SCH 52365, Temodal, Temodar, TMZ

Treatment (tipifarnib, temozolomide, radiation therapy)

radiation therapy RADIATION

Undergo partial brain radiation therapy

Also known as: irradiation, radiotherapy, therapy, radiation

Treatment (tipifarnib, temozolomide, radiation therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 MRI or contrast 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 ABTC institution; radiotherapy must be given by external beam to a partial brain field in daily fractions of 2.0 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
• Life expectancy \> 8 weeks
• Patients must have a Karnofsky performance status of \>= 60
• Patients must have adequate bone marrow function and the test must be performed within 14 days prior to registration; eligibility level for hemoglobin may be reached by transfusion
• WBC \>= 3,000/µl
• ANC \>= 1,500/mm\^3
• Platelet count of \>= 100,000/mm\^3
• Hemoglobin \>= 10 gm/dl

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Adult Brain Tumor Consortium

Baltimore, Maryland, 21231-1000, United States

Location

MeSH Terms

Conditions

Glioblastoma; Gliosarcoma

Interventions

tipifarnib; Temozolomide; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics; Physical Phenomena

Study Officials

• Timothy Cloughesy

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2002
• First Posted: January 27, 2003
• Study Start: September 1, 2002
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: April 15, 2015

Record last verified: 2013-12

Locations

US (1)