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

This study has been completed.
Sponsor:
Information provided by:
Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:
NCT00289809
First received: February 9, 2006
Last updated: December 17, 2009
Last verified: December 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
  • Phase II: Response rate (CR/PR or SD) [ Time Frame: Tumor assessment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Phase II: time to progression, duration of response, overall survival [ Time Frame: Tumor assessment, follow-up ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 9, 2006
Last Updated: December 17, 2009
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Doxorubicin
Isophosphamide mustard
Ifosfamide
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 14, 2014