TLC D-99 and Ifosfamide in Metastatic Soft Tissue Sarcoma Patients

Phase 1

Completed

• Conditions: Sarcoma, Soft Tissue

• Registration Number: NCT00289809
• Lead Sponsor: Istituto Clinico Humanitas

Brief Summary

The purpose of this study is to determine the maximum tolerated dose of the TLC D-99 combined with ifosfamide and then the efficacy of this combination in terms of overall response rate, time to progression and time of response

Detailed Description

The Maximum Tolerated Dose of the combination was determined and the Phase I terminated.

Then, Phase II study started.

Study Timeline

• Study First Submitted: 2006-02-09
• Study First Submitted QC: 2006-02-09
• Study First Posted: 2006-02-10
• Study Start: 2006-09
• Status Verified: 2009-12
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Last Update Submitted: 2009-12-17
• Last Update Posted: 2009-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Histologic diagnosis of soft tissue sarcoma metastatic or recurrent after 6 months from the last chemotherapy
• Age >/=18 yrs
• PS </=2
• Disease detectable almost for 1 dimension
• Life expectancy >/=3 mos
• Minimum 4 wks from last radiotherapy
• Adequate medullary, liver, and renal functions
• Normal LVEF
• Written Informed Consent

Exclusion Criteria

• Pregnant or breast-feeding patients
• Serious concomitant disease or not controlled infections

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Phase II: Response rate (CR/PR or SD)	Tumor assessment
Phase I: Maximum Tolerated Dose (MTD) of combination of TLC D-99 and Ifosfamide	Definition of TDL

Secondary Outcome Measures

Name	Time	Method
Phase II: time to progression, duration of response, overall survival	Tumor assessment, follow-up

Trial Locations

Locations (1)

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milan, Italy