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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00181025
Other study ID # PIP
Secondary ID CSET 2003/1053
Status Recruiting
Phase Phase 2
First received September 13, 2005
Last updated June 11, 2007
Start date May 2004

Study information

Verified date September 2006
Source Gustave Roussy, Cancer Campus, Grand Paris
Contact Sylvie Bonvalot, MD
Phone 33 1 42 11 363
Email bonvalot@igr.fr
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 33
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Resectable tumor without mutilation

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Tasonermine (TNFa)

Melphalan


Locations

Country Name City State
France Institut Gustave-Roussy Villejuif

Sponsors (1)

Lead Sponsor Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete response rate on MRI
Secondary Histological response
Secondary Objective responses
Secondary Rate of conservative treatments
Secondary Overall survival and disease free survival
Secondary Local and systemic toxicity