Temozolomide and SCH66336 for Recurrent Glioblastoma Multiforme

Glioblastoma Multiforme Clinical Trial

Official title: Phase II Evaluation Temozolomide and Farnesyl Transferase Inhibitor (SCH66336) for the Treatment of Recurrent and Progressive Glioblastoma Multiforme

Status Completed

Clinical Trial Summary

This study will combine the chemotherapy agent temozolomide with the investigational drug SCH66336 (an agent which interferes with new cell growth). Patients will be treated with oral temozolomide on days 1-5 and oral SCH66336 on days 8-28 every 28 days.

Clinical Trial Description

Temozolomide at a dose of, 150-200 mg/m2, will be administered orally, after fasting for one hour, once a day for 5 consecutive days (days 1 through 5) every 4 weeks (plus up to 3 days). The starting dose level of 200 mg/m2 will be used for patients who have not previously received any chemotherapy or at 150 mg/m2 for patients who have received previous chemotherapy.

SCH66336 will be given orally, with water, in the morning and in the evening for three weeks (Days 8 - 28) every 28 days (plus up to 3 days) 1 hour before or after morning and evening meals. Patients will take 150 mg in the morning and 150 mg in the evening.

Treatment courses may be repeated every 28 days following the first daily dose of Temozolomide for the previous course. ;

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

• NCT number: NCT00038493
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 2
• Start date: September 21, 2001
• Completion date: August 1, 2005