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Completed

NCT Number: NCT00289809

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

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

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Key information

Conditions

Sarcoma, Soft Tissue Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

About this study

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

Then, Phase II study started.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

combination of TLC D-99 and Ifosfamide

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

Primary outcomes

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

    Time frame: Definition of TDL

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

    Time frame: Tumor assessment

Secondary outcomes

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

    Time frame: Tumor assessment, follow-up

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

A Perspective Phase I and II Trial of Liposome-encapsulated Doxorubicin (TLC D-99) in Combination With Ifosfamide in Patients With Metastatic Soft Tissue Sarcoma

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Feb 10, 2006
Registry last updated
Dec 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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