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Brief Title: Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed
Official Title: Phase II Study on Tomusex in Malignant Mesothelioma
Study ID: NCT00004254
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 raltitrexed in treating patients who have malignant mesothelioma that cannot be surgically removed.
Detailed Description: OBJECTIVES: I. Determine the therapeutic activity and toxicities of raltitrexed in patients with inoperable malignant mesothelioma. II. Determine the objective response rate and duration of response in patients treated with this regimen. OUTLINE: This is a multicenter study. Within 2 weeks of staging procedures, patients receive raltitrexed IV over 15 minutes on day 1. Treatment repeats every 3 weeks for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks until disease progression and then every 8 weeks thereafter for survival. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Ospedale Bellaria, Bologna, , Italy
Istituto Nazionale per la Ricerca sul Cancro, Genoa, , Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori, Naples, , Italy
Universita Degli Studi di Udine, Udine, , Italy
Antoni van Leeuwenhoekhuis, Amsterdam, , Netherlands
Vrije Universiteit Medisch Centrum, Amsterdam, , Netherlands
Name: Giuseppe Giaccone, MD, PhD
Affiliation: Free University Medical Center
Role: STUDY_CHAIR