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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00289809
Recruitment Status : Completed
First Posted : February 10, 2006
Last Update Posted : December 18, 2009
Information provided by:
Istituto Clinico Humanitas

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 progression and time of response

Condition or disease Intervention/treatment Phase
Sarcoma, Soft Tissue Drug: combination of TLC D-99 and Ifosfamide Phase 1 Phase 2

Detailed Description:

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

Then, Phase II study started.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Ifosfamide

Intervention Details:
  • Drug: 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

Primary Outcome Measures :
  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 Outcome Measures :
  1. Phase II: time to progression, duration of response, overall survival [ Time Frame: Tumor assessment, follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00289809

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Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089
Sponsors and Collaborators
Istituto Clinico Humanitas
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Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas

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Responsible Party: Dr. Armando Santoro, Istituto Clinico Humanitas Identifier: NCT00289809     History of Changes
Other Study ID Numbers: ONC-2005-001
EUDRACT 2005-004569-40
First Posted: February 10, 2006    Key Record Dates
Last Update Posted: December 18, 2009
Last Verified: December 2009
Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Isophosphamide mustard
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents