Spots Global Cancer Trial Database for Endostatin in Treating Patients With Advanced Solid Tumors

Study Description

Brief Summary: Phase I trial to study the effectiveness of endostatin in treating patients who have advanced solid tumors. Endostatin may stop the growth of cancer by stopping blood flow to the tumor.

Detailed Description: OBJECTIVES: I. Determine the optimal biologic dose of endostatin in patients with advanced solid tumors. II. Determine the safety and tolerability of this regimen in these patients. III. Determine the extent, frequency, and duration of tumor response in these patients on this regimen. IV. Determine the pharmacokinetic profile and interpatient pharmacologic variability of this regimen in these patients. V. Determine the recommended phase II dose and schedule of this regimen. OUTLINE: This is a dose escalation study. Patients undergo a biopsy during prestudy and after the second course of treatment. Patients receive endostatin IV daily for 4 weeks. Patients on dose level 1-6 receive endostatin over 20 minutes. Patients on dose level 7 receive endostatin over 40 minutes, with no treatment on day 2 of the first course only. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of endostatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed for 1 month.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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