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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00289809
First Posted: February 10, 2006
Last Update Posted: December 18, 2009
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.
Information provided by:
Istituto Clinico Humanitas
  Purpose
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 Intervention Phase
Sarcoma, Soft Tissue Drug: combination of TLC D-99 and Ifosfamide Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Istituto Clinico Humanitas:

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

Estimated Enrollment: 36
Study Start Date: September 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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
Detailed Description:

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

Then, Phase II study started.

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00289809


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

Responsible Party: Dr. Armando Santoro, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT00289809     History of Changes
Other Study ID Numbers: ONC-2005-001
EUDRACT 2005-004569-40
First Submitted: February 9, 2006
First Posted: February 10, 2006
Last Update Posted: December 18, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Ifosfamide
Isophosphamide mustard
Liposomal doxorubicin
Doxorubicin
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors