Suspended

Phase I Study Of SCH66336 (Lonafarnib), A Farnesyl Protein Transferase Inhibitor In Combination With Temozolomide In Gliomas

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What is being tested

Data Collection

Who is being recruted

Glioma
+9

+ Neoplasms
+ Neoplasms by Histologic Type
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: March 2004
See protocol details

Summary

Principal SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2004Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the maximum tolerated dose and dose-limiting toxicity of lonafarnib when administered with temozolomide in patients with recurrent primary supratentorial gliomas. * Determine the safety and tolerability of this regimen in these patients. Secondary * Determine the mechanism of action of lonafarnib in these patients. * Determine the pharmacodynamics and pharmacokinetics of this regimen in these patients. * Determine the activity of this regimen in these patients. * Determine the response to this regimen in patients who have measurable disease. OUTLINE: This is a nonrandomized, multicenter, open-label, dose-escalation study of lonafarnib. Patients receive oral temozolomide once daily on days 2-6 of course 1 and on days 1-5 of all subsequent courses. Patients also receive oral lonafarnib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of lonafarnib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 1 of 6 patients experience dose-limiting toxicity. An additional 3 patients may be treated at the highest dose level achieved. Patients are followed every 8 weeks for 6 months and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.

Official TitlePhase I Study Of SCH66336 (Lonafarnib), A Farnesyl Protein Transferase Inhibitor In Combination With Temozolomide In Gliomas 
NCT00083096
Principal SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
30 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Nervous System Diseases
Nervous System Neoplasms
Central Nervous System Neoplasms
Neuroectodermal Tumors
Neoplasms, Neuroepithelial
Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed primary supratentorial glioma * Multifocal disease allowed * Recurrent disease after prior surgery and/or radiotherapy * Radiological evidence of increased and/or enhanced target lesion * Amenable to temozolomide therapy PATIENT CHARACTERISTICS: Age * Over 18 Performance status * ECOG 0-2 OR * WHO 0-2 Life expectancy * Not specified Hematopoietic * Neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10.0 g/dL Hepatic * Alkaline phosphatase \< 2.5 times upper limit of normal (ULN) * Transaminases \< 2.5 times ULN * Bilirubin \< 1.5 times ULN Renal * Creatinine \< 1.7 mg/dL Cardiovascular * Cardiac function clinically normal * Normal 12-lead ECG * QTc ≤ 440 msec on ECG * No ischemic heart disease within the past 6 months Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * No unstable systemic disease * No active uncontrolled infection * No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up * No other active or recurrent malignancy within the past 5 years except cone biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent anticancer biologic agents Chemotherapy * At least 4 weeks since prior chemotherapy (6 weeks for temozolomide) * Prior adjuvant chemotherapy allowed * No more than 1 prior chemotherapy regimen for recurrent disease * No other concurrent chemotherapy Endocrine therapy * Concurrent corticosteroids allowed provided treatment remains at a stable or decreasing dose for at least 2 weeks Radiotherapy * See Disease Characteristics * No concurrent radiotherapy Surgery * See Disease Characteristics * At least 3 months since prior surgery for primary brain tumor Other * Concurrent anticonvulsants allowed * No other concurrent anticancer agents * No other concurrent investigational therapy


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 3 locations
Suspended
Centre de Lutte Contre le Cancer Georges-Francois LeclercDijon, FranceSee the location
Suspended
Centre Regional Rene GauducheauNantes-Saint Herblain, France
Suspended
Centre Hospitalier Universitaire VaudoisLausanne, Switzerland

Suspended3 Study Centers
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