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Home > "T" Clinical Trials Conditions > Tipifarnib in Treating Patients With Recurrent or Progressive Malignant Glioma  Tipifarnib in Treating Patients With Recurrent or Progressive Malignant Glioma
Tipifarnib in Treating Patients With Recurrent or Progressive Malignant Glioma
For Condition: recurrent adult brain tumor,adult glioblastoma multiforme
Status: Recruiting
Sponsor(s): North American Brain Tumor Consortium , National Cancer Institute (NCI)
Synopsis: RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase II trial to study the effectiveness of tipifarnib in treating patients who have recurrent or progressivemalignantglioma.
Details: OBJECTIVES: - Determine the maximum tolerated dose of tipifarnib in patients with recurrent or progressive malignant glioma receiving enzyme-inducing antiepileptic drugs. (Stratum II in the phase I portion of this study closed to accrual effective 07/16/2001.) (Phase I completed effective 10/2/2001.) (Phase II open only to patients requiring resection and who provide surgical tissue samples [effective 3/13/2003].) - Define the safety and pharmacokinetic profile of this drug in this patient population. - Assess for evidence of antitumor activity of this drug in these patients. - Assess for evidence of inhibition of farnesyl protein transferase (FTase) on peripheral blood monocytes as a surrogate endpoint of effective biologic activity of this drug in these patients. - Determine the efficacy of this drug as measured by 6-month progression-free survival and objective tumor response in these patients. - Evaluate further the safety profile of this drug in these patients. - Correlate treatment response with inhibition of FTase in peripheral blood monocytes in patients treated with this drug. OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to their pretreatment medications (not receiving enzyme-inducing antiepileptic drugs [EIAEDs] vs receiving EIAEDs with or without steroids). Patients receive oral tipifarnib twice daily on days 1-21. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression. - Phase I (completed 10/2/2001): Cohorts of 3-6 patients from stratum II receive escalating doses of tipifarnib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. (Stratum II in the phase I portion of this study closed to accrual effective 07/16/2001.) - Phase II (open only to patients requiring resection and who provide surgical tissue samples [effective 3/13/2003]): Once the MTD is determined, additional patients with glioblastoma multiforme from stratum II are accrued to receive treatment with tipifarnib at the recommended phase II dose. Patients are followed every 2 months for 1 year, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months until progression. Patients are then followed every 4 months thereafter. PROJECTED ACCRUAL: Approximately 30 patients (15 per stratum) will be accrued for the phase I portion of this study within 10 months. (Stratum II in the phase I portion of this study closed to accrual effective 07/16/2001.) (Phase I completed effective 10/2/2001.) A total of 24 patients with glioblastoma multiforme from stratum II will be accrued for the phase II portion of this study. (Phase II open only to patients requiring resection and who provide surgical tissue samples [effective 3/13/2003].)
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed intracranial primary malignant glioma - Glioblastoma multiforme - Anaplastic astrocytoma* - Anaplastic oligodendroglioma* - Anaplastic mixed oligodendroglioma* - Malignant astrocytoma (not otherwise specified)* NOTE: *Closed to accrual effective 5/28/2002 - Progressive or recurrent disease confirmed by MRI or CT scan within the past 14 days - Stable steroid dose for at least 5-7 days - Confirmation of true progressive disease by PET scan, thallium scan, MR spectroscopy, or surgery if prior therapy included interstitial brachytherapy or stereotactic radiosurgery - Failed prior radiotherapy - Phase I (phase I completed effective 10/2/2001): No more than 2 prior chemotherapy or cytotoxic regimens, including 1 prior adjuvant therapy and 1 prior regimen for progressive or recurrent disease, or 2 prior regimens for progressive disease - No more than 2 prior chemotherapy or cytotoxic regimens for relapsed disease following initial therapy (radiotherapy with or without chemotherapy) - Prior surgical resection for relapsed disease with no anticancer therapy for up to 12 weeks followed by another surgical resection is considered 1 relapse - Patients who received prior therapy for a low-grade glioma with a surgical diagnosis of a high-grade glioma are considered to be in first relapse PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - More than 8 weeks Hematopoietic: - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic: - Bilirubin no greater than 2.5 times upper limit of normal (ULN) - SGOT no greater than 2.5 times ULN Renal: - Creatinine less than 1.5 mg/dL Cardiovascular: - No uncontrolled high blood pressure - No unstable angina - No symptomatic congestive heart failure - No myocardial infarction within the past 6 months - No serious uncontrolled cardiac arrhythmia Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No severe nonmalignant systemic diseases or active infections - No other severe concurrent disease that would preclude study therapy - No allergy to azoles (e.g., ketoconazole, itraconazole, or voriconazole) - HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 1 week since prior interferon - No concurrent anticancer immunotherapy - No concurrent routine prophylactic filgrastim (G-CSF) during first course of study - No concurrent sargramostim (GM-CSF) Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, suramin, or mitomycin) - At least 3 weeks since prior procarbazine - At least 2 weeks since prior vincristine - No other concurrent anticancer chemotherapy Endocrine therapy: - See Disease Characteristics - At least 1 week since prior tamoxifen - Concurrent corticosteroids allowed - No concurrent anticancer hormonal therapy Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy and recovered - No concurrent anticancer radiotherapy Surgery: - See Disease Characteristics - At least 3 weeks since prior resection and recovered - Prior recent resection of recurrent or progressive tumor allowed Other: - Recovered from all prior therapy (excluding neurotoxicity or alopecia) - Prior radiosensitizers allowed - Concurrent H2 blockers and antacids allowed provided taken at least 2 hours before and after tipifarnib - No concurrent proton pump inhibitors (e.g., omeprazole or lansoprazole) - No other concurrent medication that would preclude study therapy (e.g., immunosuppressive agents) - No other concurrent anticancer therapy - No other concurrent investigational drugs - No concurrent participation in any other clinical study - No other concurrent medications except analgesics, chronic treatments for concurrent medical conditions, or agents for life-threatening medical problems
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TimothyCloughesy, Study Chair, Jonsson Comprehensive Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Lisa DeAngelis 212-639-7123
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Wai-Kwan Yung 713-794-1285
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095
United States
Recruiting Timothy Cloughesy 310-825-5321
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792
United States
Recruiting Minesh Mehta 608-263-8500
University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio, Texas, 78284-6220
United States
Recruiting John Kuhn 210-567-8355
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Patrick Wen 617-632-2166
University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor, Michigan, 48109-0942
United States
Recruiting Harry Greenberg 734-936-1831
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Michael Prados 415-353-9510
Hillman Cancer Center at University of Pittsburgh Cancer Institute *Recruiting*
Pittsburgh, Pennsylvania, 15232
United States
Recruiting Frank Lieberman 412-692-2600
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390-9154
United States
Recruiting Karen Fink 214-648-4730
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 1-888-NCI-1937
Additional Information:
Study ID Numbers: CDR0000067888; NABTC-9901
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005859
Other Recurrent Adult Brain Tumor Studies:
1. CC-8490 in Treating Patients With Recurrent or Refractory High-Grade Gliomas
2. Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma
3. Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme
4. Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma
5. Internal Radiation Therapy Plus Carmustine Implants in Treating Patients With Recurrent or Refractory Malignant Glioma
Related Studies:
Other recurrent adult brain tumor Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Tipifarnib in Treating Patients With Recurrent or Progressive Malignant Glioma
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