Hematopoietic Stem Cell Transplantation From Human Leukocyte Antigen (HLA) Compatible Donor in Ewing Sarcomas and Soft Tissues Sarcomas

Soft Tissue Sarcoma Clinical Trial

Official title:

Hematopoietic Stem Cell Transplantation From HLA Compatible Donor in Ewing Sarcomas and Soft Tissues Sarcomas

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00998361
• Other study ID #: CE_clin.42_2009_S_sper
• Status: Active, not recruiting
• Phase: Phase 2
• First received: October 18, 2009
• Last updated: October 19, 2009
• Start date: June 2009
• Est. completion date: June 2011

Study information

• Verified date: October 2009
• Source: St. Orsola Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This is a perspective multicentric study for the treatment of patients aged equal or less than 60 years and submitted to an allogeneic hematopoietic stem cell transplantation from an HLA compatible related or unrelated donor because affected by resistent or refractory or relapsed after autologous stem cell transplantation Ewing Sarcoma or Soft tissues sarcoma who did not benefit from conventional therapy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: June 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 60 Years

Eligibility

Inclusion Criteria:

• Age 0-60 years.

• Performance status according to Karnofsky score > 70%

• Normal liver function

• Normal renal function

• Normal cardiac function

• Informed consent

• Availability of an HLA compatible Donor

Exclusion Criteria:

• Absence of at least one of the inclusion criteria

Study Design

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

Related Conditions & MeSH terms

• Ewing
• Sarcoma
• Sarcoma, Ewing
• Soft Tissue Sarcoma

Intervention

Procedure:
• Allogeneic hemopoietic stem cell transplant
administration of 15 mg/kg of thiotepa + 140 mg/sqm of melphalan followed by infusion of allogeneic hemopoietic stem cell

Locations

Country	Name	City	State
Italy	Pediatric Oncology and Hematology Department, S. Orsola-Malpighi Hospital	Bologna

Sponsors (2)

Lead Sponsor	Collaborator
St. Orsola Hospital	S. Anna Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS) a 12 months from the enrollment higher than 30% for the patients submitted to allogeneic stem cell transplantation in front of the patients who received conventional chemotherapy.		12 months from the enrollement	Yes
Secondary	Transplant related mortality		12 months after the enrollement of the first patients	Yes