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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. The completion date has passed and the status has not been verified in more than two years.
Verified September 2006 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00181025
First received: September 13, 2005
Last updated: June 11, 2007
Last verified: September 2006
  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:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

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   (Child, Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00181025

Locations
France
Institut Gustave-Roussy
Villejuif, France, 94800
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Principal Investigator: Sylvie Bonvalot, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

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 Gustave Roussy, Cancer Campus, Grand Paris:
Limbs’ girdle

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

ClinicalTrials.gov processed this record on December 09, 2016