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

Istituto Clinico Humanitas36 enrolled

Overview

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

The Maximum Tolerated Dose of the combination was determined and the Phase I terminated. Then, Phase II study started.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sarcoma, Soft Tissue

Interventions

combination of TLC D-99 and IfosfamideDRUG

* TLC D-99: 40 mg/m2 Day 1 every 3 weeks; * Ifosfamide: 3000 mg/m2 Day 1, 2, 3 every 3 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Istituto Clinico Humanitas

Rozzano, Milan, Italy

Outcomes

Primary Outcomes

Phase I: Maximum Tolerated Dose (MTD) of combination of TLC D-99 and Ifosfamide

Time frame: Definition of TDL

Phase II: Response rate (CR/PR or SD)

Time frame: Tumor assessment

Secondary Outcomes

Phase II: time to progression, duration of response, overall survival

Time frame: Tumor assessment, follow-up

Data from ClinicalTrials.gov

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