Tipifarnib and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Adult Glioblastoma Clinical Trial

Official title: Phase II Study of R115777 for the Treatment of Adults With Newly Diagnosed Glioblastoma Multiforme

Status Completed

Clinical Trial Summary

Phase II trial to study the effectiveness of combining tipifarnib with radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining tipifarnib with radiation therapy may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To estimate overall survival in newly diagnosed patients with glioblastoma multiforme treated with R115777 before (and possibly after) radiation therapy.

SECONDARY OBJECTIVES:

I. To estimate response rate in adult patients with newly diagnosed glioblastoma multiforme treated with R115777 prior to therapy with radiation.

II. To estimate progression free survival in newly diagnosed patients with glioblastoma multiforme treated with R115777 before (and possibly after) radiation therapy.

III. To describe the toxicity associated with this regimen in adult patients with newly diagnosed glioblastoma multiforme.

OUTLINE: This is a multicenter study.

INDUCTION THERAPY: Patients receive oral tipifarnib twice daily for 3 weeks. Treatment repeats every 4 weeks for up to 3 courses.

RADIOTHERAPY: Within 14 days after the completion of induction therapy, patients undergo radiotherapy daily, 5 days a week, for 6 weeks.

MAINTENANCE THERAPY: Two weeks after the completion of radiotherapy, patients receive additional tipifarnib as in induction therapy.

Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A minimum of 54 patients will be accrued for this study within 11-14 months. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adult Giant Cell Glioblastoma
• Adult Glioblastoma
• Adult Gliosarcoma
• Glioblastoma
• Gliosarcoma

• NCT number: NCT00058097
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 2
• Start date: August 2003