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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by St. Orsola Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
S. Anna Hospital
Information provided by:
St. Orsola Hospital
ClinicalTrials.gov Identifier:
NCT00998361
First received: October 18, 2009
Last updated: October 19, 2009
Last verified: October 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Ewing
Soft Tissue Sarcoma
 Procedure: Allogeneic hemopoietic stem cell transplant
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hematopoietic Stem Cell Transplantation From HLA Compatible Donor in Ewing Sarcomas and Soft Tissues Sarcomas

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Orsola Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Transplant related mortality [ Time Frame: 12 months after the enrollement of the first patients ] [ Designated as safety issue: Yes ]

Enrollment: 140
Study Start Date: June 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stem Cell Transplant
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
 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
Other Name: CE_clin.42_2009_S_sper

  Eligibility

Ages Eligible for Study:   1 Month to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00998361

Locations
Italy
Pediatric Oncology and Hematology Department, S. Orsola-Malpighi Hospital
Bologna, Italy, 40138
Sponsors and Collaborators
St. Orsola Hospital
S. Anna Hospital
Investigators
Principal Investigator: Arcangelo Prete, MD, PhD, PI S. Orsola-Malpighi Hospital
  More Information

No publications provided

Responsible Party: Dr Augusto Cavina, S. Orsola-Malpighi Hospital
ClinicalTrials.gov Identifier: NCT00998361     History of Changes
Other Study ID Numbers: CE_clin.42_2009_S_sper
Study First Received: October 18, 2009
Last Updated: October 19, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by St. Orsola Hospital:
Sarcoma
allogeneic
Hemopoietic stem cell transplant

Additional relevant MeSH terms:
Sarcoma, Ewing's
Neuroectodermal Tumors, Primitive, Peripheral
Sarcoma
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
 Neoplasms
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on May 21, 2013