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

Istituto Clinico Humanitas

Status and phase: Completed; Phase 2; Phase 1

Conditions: Sarcoma, Soft Tissue

Treatments: Drug: combination of TLC D-99 and Ifosfamide

Study type: Interventional

Funder types: Other

Identifiers

NCT00289809

EUDRACT 2005-004569-40

ONC-2005-001

Details and patient eligibility

About

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

Full description

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

Then, Phase II study started.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)