NCT00012116

Temozolomide in Treating Patients With Solid Tumors That Have Spread to the Brain

Temozolomide For Patients With Cerebral Metastases Who Have Failed Radiation Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have advanced solid tumors that have spread to the brain.

Detailed description

OBJECTIVES: I. Assess the response rate of patients with cerebral metastases who have failed or refused standard therapy when treated with temozolomide. II. Assess the safety and tolerability of this drug in these patients. III. Determine the quality of life of patients treated with this drug. IV. Determine the response rate of systemic disease outside the central nervous system in patients treated with this drug. OUTLINE: Patients receive oral temozolomide daily for 6 weeks. Treatment repeats every 10 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Quality of life is assessed on day 1 of each 10-week course. Patients are followed for 30 days. PROJECTED ACCRUAL: A total of 18-48 patients will be accrued for this study within 2 years.

Conditions

• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	temozolomide	Administered in a fasting state, once a day for 6 weeks followed by 4 weeks of rest. Cycles may be repeated every 10 weeks until patients have evidence of progressive disease, intolerable toxicity or unwillingness to continue therapy. Daily dose: 75mg/m2.

Timeline

• Start date: 2000-10-01
• Primary completion: 2002-04-01
• Completion: 2002-04-01
• First posted: 2004-01-01
• Last updated: 2020-08-03

Locations

1 site across 1 country: United States