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

This study is currently recruiting participants.

Verified by Institut Gustave Roussy, September 2006

Sponsored by:	Institut Gustave Roussy
Information provided by:	Institut Gustave Roussy
ClinicalTrials.gov Identifier:	NCT00181025

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 II

MedlinePlus related topics: Soft Tissue Sarcoma

Drug Information available for: Melphalan Melphalan hydrochloride Sarcolysin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Isolated Pelvic and Limb Perfusion With 1mg TNFa in the Treatment of Locally Advanced Sarcoma of Pelvis and Limbs’ Girdle

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

Study ID Numbers:	PIP, CSET 2003/1053
Study First Received:	September 13, 2005
Last Updated:	June 11, 2007
ClinicalTrials.gov Identifier:	NCT00181025
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Institut Gustave Roussy:

Limbs’ girdle

Study placed in the following topic categories:

Melphalan
Neoplasms, Connective and Soft Tissue
Malignant mesenchymal tumor
Sarcoma
Soft tissue sarcomas

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009