NCT00102648

Lonafarnib and Temozolomide in Treating Patients with Glioblastoma Multiforme That is Recurrent or Did Not Respond to Previous Treatment with Temozolomide

Phase I/Ib Study of Sarasar and Temodar in Patients with Recurrent or Temodar-Refractory Glioblastoma Multiforme

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of lonafarnib when given together with temozolomide and to see how well they work in treating patients with glioblastoma multiforme that is has come back or did not respond to previous treatment with temozolomide. Lonafarnib may stop the growth of tumor cells by blocking some of the enzymes needed for 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, by stopping them from dividing, or by stopping them from spreading. Giving lonafarnib together with temozolomide may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose Sarasar (SCH66336, lonafarnib) when combined with Temodar (temozolomide) in an alternating week schedule. II. To describe the toxicities of the Sarasar and Temodar combination treatment using this dosing schedule. III. To evaluate response as measured by 6-month progression-free survival and objective tumor response. OUTLINE: This is a dose-escalation study of lonafarnib. Patients receive temozolomide orally (PO) once daily (QD) on days 1-7 and 15-21 and lonafarnib PO twice daily (BID) on days 8-14 and 22-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months.

Conditions

• Malignant Supratentorial Neoplasm
• Recurrent Glioblastoma
• Recurrent Gliosarcoma

Interventions

Type	Name	Description
DRUG	Lonafarnib	Given PO
DRUG	Temozolomide	Given PO

Timeline

• Start date: 2004-12-21
• Primary completion: 2025-03-01
• Completion: 2025-12-01
• First posted: 2005-02-01
• Last updated: 2024-10-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study