Overview

This trial is active, not recruiting.

Conditions ewing, soft tissue sarcoma
Treatment allogeneic hemopoietic stem cell transplant
Phase phase 2
Sponsor St. Orsola Hospital
Collaborator S. Anna Hospital
Start date June 2009
End date June 2010
Trial size 140 participants
Trial identifier NCT00998361, CE_clin.42_2009_S_sper

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
All the patient who are affected by refractory or resistant or relapsed Soft tissue sarcoma o Ewing sarcoma who find an HLA compatible allogeneic donor and are submitted to Stem cell transplantation
allogeneic hemopoietic stem cell transplant CE_clin.42_2009_S_sper
administration of 15 mg/kg of thiotepa + 140 mg/sqm of melphalan followed by infusion of allogeneic hemopoietic stem cell

Primary Outcomes

Measure
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.
time frame: 12 months from the enrollement

Secondary Outcomes

Measure
Transplant related mortality
time frame: 12 months after the enrollement of the first patients

Eligibility Criteria

Male or female participants from 1 month up to 60 years old.

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

Additional Information

Official title Hematopoietic Stem Cell Transplantation From HLA Compatible Donor in Ewing Sarcomas and Soft Tissues Sarcomas
Principal investigator Arcangelo Prete, MD, PhD, PI
Trial information was received from ClinicalTrials.gov and was last updated in October 2009.
Information provided to ClinicalTrials.gov by St. Orsola Hospital.