Tipifarnib in Treating Patients With Recurrent or Progressive Malignant Glioma

NCT00005859 | Completed Phase 1 FDA Drug

• 3 other identifiers: NABTC-9901CDR0000067888U01CA062455
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 11

Brief Summary

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 progressive malignant glioma.

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumor; adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma

Interventions

tipifarnib DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 * Phase II (phase II open only to patients requiring resection and who provide surgical tissue samples \[effective 3/13/2003\]): 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (11)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Hillman Cancer Center at University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390-9154, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-6220, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

• Cloughesy TF, Wen PY, Robins HI, Chang SM, Groves MD, Fink KL, Junck L, Schiff D, Abrey L, Gilbert MR, Lieberman F, Kuhn J, DeAngelis LM, Mehta M, Raizer JJ, Yung WK, Aldape K, Wright J, Lamborn KR, Prados MD. Phase II trial of tipifarnib in patients with recurrent malignant glioma either receiving or not receiving enzyme-inducing antiepileptic drugs: a North American Brain Tumor Consortium Study. J Clin Oncol. 2006 Aug 1;24(22):3651-6. doi: 10.1200/JCO.2006.06.2323.

  PMID: 16877733 RESULT

• Cloughesy TF, Kuhn J, Robins HI, Abrey L, Wen P, Fink K, Lieberman FS, Mehta M, Chang S, Yung A, DeAngelis L, Schiff D, Junck L, Groves M, Paquette S, Wright J, Lamborn K, Sebti SM, Prados M. Phase I trial of tipifarnib in patients with recurrent malignant glioma taking enzyme-inducing antiepileptic drugs: a North American Brain Tumor Consortium Study. J Clin Oncol. 2005 Sep 20;23(27):6647-56. doi: 10.1200/JCO.2005.10.068.

  PMID: 16170172 RESULT

MeSH Terms

Conditions

Central Nervous System Neoplasms; Brain Neoplasms; Glioblastoma; Gliosarcoma

Interventions

tipifarnib

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Timothy F. Cloughesy, MD

  Jonsson Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: January 27, 2003
• Study Start: May 16, 2000
• Primary Completion: July 1, 2005
• Study Completion: August 1, 2006
• Last Updated: June 26, 2018

Record last verified: 2018-06

Locations

US (11)