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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituto Clinico Humanitas
• Treatments: Doxorubicin; Ifosfamide; Isophosphamide mustard; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• Histologic diagnosis of soft tissue sarcoma metastatic or recurrent after 6 months from the last chemotherapy

• Age >/=18 yrs

• PS
• 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