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Isolated Pelvic and Limb Perfusion in the Treatment of Locally Advanced Sarcoma of Pelvis and Limbs’ Girdle

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Institut Gustave Roussy.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Institut Gustave Roussy
ClinicalTrials.gov Identifier:
NCT00181025
First received: September 13, 2005
Last updated: June 11, 2007
Last verified: September 2006
History of Changes
  Purpose

This study looks at isolated pelvic perfusion and limbs' girdle with 1 mg tumor necrosis factor alpha (TNFa) in the treatment of locally advanced sarcoma of the pelvis and limbs’ girdle.


Condition Intervention Phase
Sarcoma of Pelvis
 Drug: Tasonermine (TNFa)
Drug: Melphalan
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Isolated Pelvic and Limb Perfusion With 1mg TNFa in the Treatment of Locally Advanced Sarcoma of Pelvis and Limbs’ Girdle

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut Gustave Roussy:

Primary Outcome Measures:
  • Complete response rate on MRI

Secondary Outcome Measures:
  • Histological response
  • Objective responses
  • Rate of conservative treatments
  • Overall survival and disease free survival
  • Local and systemic toxicity

Estimated Enrollment: 33
Study Start Date: May 2004
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Soft tissue or bone sarcomas locally advanced of the pelvis or limbs’ girdle

Exclusion Criteria:

  • Resectable tumor without mutilation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00181025

Contacts
Contact: Sylvie Bonvalot, MD 33 1 42 11 363 bonvalot@igr.fr

Locations
France
Institut Gustave-Roussy Recruiting
Villejuif, France, 94800
Contact: Sylvie Bonvalot, MD     33 1 42 11 35 63     bonvalot@igr.fr    
Sponsors and Collaborators
Institut Gustave Roussy
Investigators
Principal Investigator: Sylvie Bonvalot, MD Institut Gustave Roussy
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00181025     History of Changes
Other Study ID Numbers: PIP, CSET 2003/1053
Study First Received: September 13, 2005
Last Updated: June 11, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Gustave Roussy:
Limbs’ girdle

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Melphalan
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
 Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013