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Home > "L" Clinical Trials Conditions > Lonafarnib and Temozolomide in Treating Patients With Recurrent Primary Supratentorial Gliomas  Lonafarnib and Temozolomide in Treating Patients With Recurrent Primary Supratentorial Gliomas
Lonafarnib and Temozolomide in Treating Patients With Recurrent Primary Supratentorial Gliomas
For Condition: adult ependymoma,Adult Oligodendroglioma,adult noninfiltrating astrocytoma,Mixed Gliomas,adult brain tumor,adult infiltrating astrocytoma
Status: Recruiting
Sponsor(s): EORTC New Drug Development Group , EORTC Brain Tumor Cooperative Group
Synopsis: RATIONALE: Lonafarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy such as temozolomide work in different ways to stop tumor cells from dividing so they stop growing or die. Combining lonafarnib with temozolomide may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining lonafarnib with temozolomide in treating patients who have recurrentprimarysupratentorialglioma.
Details: 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. Once the MTD is determined, one additional dose level may be explored to assess the feasibility and toxicity profile by increasing the dose of temozolomide while the dose of lonafarnib remains at the MTD. 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RogerStupp, Study Chair, Centre Hospitalier Universitaire Vaudois
Centre Hospitalier Universitaire Vaudois *Recruiting*
Lausanne, , CH-1011
Switzerland
Recruiting Roger Stupp 41-21-314-0156
Centre Regional Rene Gauducheau *Recruiting*
Nantes-Saint-Herblain, , 44805
France
Recruiting Mario Campone 33-02-4067-9977
Additional Information:
Study ID Numbers: CDR0000362066; EORTC-26023,SPRI-P03174,EORTC-16027
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00083096
Other Adult Infiltrating Astrocytoma Studies:
1. Imatinib Mesylate in Treating Patients With Gliomas
2. Lonafarnib and Temozolomide in Treating Patients With Recurrent Primary Supratentorial Gliomas
3. Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma
4. Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma
5. Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma
Related Studies:
Other adult infiltrating astrocytoma Clinical Trials
Other Clinical Trials
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Lonafarnib and Temozolomide in Treating Patients With Recurrent Primary Supratentorial Gliomas
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