Spots Global Cancer Trial Database for Ecteinascidin 743 in Treating Patients With Previously Treated Metastatic Osteosarcoma

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Trial Identification

Brief Title: Ecteinascidin 743 in Treating Patients With Previously Treated Metastatic Osteosarcoma

Official Title: Phase II Study of ET-743 Therapy in Metastatic Osteosarcoma

Study ID: NCT00005625

Conditions

Sarcoma

Interventions

trabectedin

Study Description

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 ecteinascidin 743 in treating patients who have previously treated metastatic osteosarcoma.

Detailed Description: OBJECTIVES: I. Determine the partial and complete response rate in patients with previously treated metastatic osteosarcoma when treated with ecteinascidin 743. II. Further characterize the toxicity profile and the pharmacokinetic-pharmacodynamic relationships of this drug in this patient population. OUTLINE: This is a multicenter study. Patients receive ecteinascidin 743 IV over 24 hours. Treatment continues every 6 weeks in the absence of unacceptable toxicity or disease progression for at least 2-6 courses. Patients with a complete response (CR) receive at least 2 additional courses after documented CR. Patients are followed every 3 months until disease progression. All patients are followed until death after disease progression. PROJECTED ACCRUAL: A total of 25-33 patients will be accrued for this study.