Status:
COMPLETED
TLC D-99 and Ifosfamide in Metastatic Soft Tissue Sarcoma Patients
Lead Sponsor:
Istituto Clinico Humanitas
Conditions:
Sarcoma, Soft Tissue
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 progr...
Detailed Description
The Maximum Tolerated Dose of the combination was determined and the Phase I terminated. Then, Phase II study started.
Eligibility Criteria
Inclusion
- 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
- Pregnant or breast-feeding patients
- Serious concomitant disease or not controlled infections
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00289809
Start Date
September 1 2006
End Date
December 1 2009
Last Update
December 18 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089