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

Phase 2

Completed

• Conditions: Metastatic Cancer
• Interventions: Drug: temozolomide

• Registration Number: NCT00012116
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief 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.

Study Timeline

• Study Start: 2000-10
• Study First Submitted: 2001-03-03
• Primary Completion: 2002-04
• Study Completion: 2002-04
• Study First Submitted QC: 2003-12-31
• Study First Posted: 2004-01-01
• Status Verified: 2012-07
• Last Update Submitted: 2020-07-30
• Last Update Posted: 2020-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
temozolomide	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.

Primary Outcome Measures

Name	Time	Method
To assess the rate of response/control of cerebral metastases from solid tumors to extended low dose, continuous oral temozolomide	2 years

Secondary Outcome Measures

Name	Time	Method
to measure quality of life in patients with cerebral metastases treated with low dose, continuous temozolomide	2 years
To assess the safety and tolerability of low dose, continuous oral temozolomide in this patient population	2 years
To measure the rate of response of systemic disease outside the central nervous system to extended low dose continuous oral temozolomide	2 years

Trial Locations

Locations (1)

Jonsson Comprehensive Cancer Center, UCLA; 🇺🇸 Los Angeles, California, United States