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

NCT ID: NCT00289809

Last Updated: 2009-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-12-31

Brief Summary

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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

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

Then, Phase II study started.

Conditions

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Sarcoma, Soft Tissue

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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combination of TLC D-99 and Ifosfamide

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Clinico Humanitas

OTHER

Sponsor Role lead

Responsible Party

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Istituto Clinico Humanitas

Principal Investigators

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Armando Santoro, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Clinico Humanitas

Locations

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Istituto Clinico Humanitas

Rozzano, Milan, Italy

Site Status

Countries

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Italy

Other Identifiers

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EUDRACT 2005-004569-40

Identifier Type: -

Identifier Source: secondary_id

ONC-2005-001

Identifier Type: -

Identifier Source: org_study_id