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A Phase I Study to Examine the Toxicity of Allogeneic Stem Cell Transplantation for Relapsed or Therapy Refractory EWING SARCOMA and RHABDOMYOSARCOMA (ASCT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Louisville
Sponsor:
Information provided by (Responsible Party):
Kenneth Lucas, University of Louisville
ClinicalTrials.gov Identifier:
NCT01969942
First received: October 21, 2013
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to examine the toxicity of using allogeneic stem cell transplantation for treatment of subjects with relapsed or refractory Ewing Sarcoma (ES) and rhabdomyosarcoma. Donors will consist of either Human Leukocyte Antigen identical (HLA)or 9/10 (A, B, C, DR, DQ [A, B, C, are Class I markers for HLA and DR and DQ are Class II markers for Matching for Transplant for Donors to match with recipient]) matched related or unrelated donors. Specifically, we will examine:

  • The toxicity of allogeneic stem cell transplant (SCT) in this patient population, as related to incidence of grade 3-4 acute Graft Verse Host Disease (GVHD).
  • The incidence of transplant related mortality at 100 days.

Condition Intervention Phase
Ewing Sarcoma
Rhabdomyosarcoma
Biological: allogeneic stem cell transplantation
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study to Examine the Toxicity of Allogeneic Stem Cell Transplantation for Relapsed or Therapy Refractory EWING SARCOMA and RHABDOMYOSARCOMA

Resource links provided by NLM:


Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Development of Grade 3-4 GVHD [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: October 2013
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: allogeneic stem cell transplantation Biological: allogeneic stem cell transplantation

  Eligibility

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 0-30 years with relapsed or therapy refractory Ewings sarcoma or rhabdomyosarcoma, excluding patients with brain metastases.
  • Patients who have received a prior autologous stem cell transplant are eligible.
  • Related and unrelated marrow and peripheral blood stem donors must be 9/10 or 10/10 (HLA A, B, C, DR, DQ) matched with the recipient.
  • Patients with an isolated local recurrence of their tumor (in the site of the primary tumor) greater than 1 year after completing therapy are excluded, as these patients could be cured with local therapy alone.
  • As a part of the standard of care for pre-transplant evaluation, subjects will be tested for exposure to viral agents such as hepatitis B, C, Human T-Lymphotropic Verse (HTLV)-1/2, and HIV.
  • Subjects testing positive for HIV may be rejected as candidates for transplantation, based on the clinical judgment of the stem cell transplant physician.

Exclusion Criteria:

  • Organ dysfunction: Patients who have the following levels of organ system dysfunction are not eligible:

    • Cardiac: Ejection Fraction less than 50 precent
    • Renal: Est. Creatinine Clearance less than 50 Hepatic: Bilirubin greater than 3.0
    • Pulmonary: Diffusing Capacity for Carbon Monoxide (DLCO) less than 70 precent, or for patient who cannot cooperate with pulmonary function testing, O2 saturation less than 95 precent on room air.
  • Performance status:

    • Lansky performance less than 70;
    • Eastern Cooperative Oncology Group (ECOG) status greater than 2
  • Pregnant females will not be allowed to participate in this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01969942

Contacts
Contact: Kenneth Lucas, M.D. 502-852-8450 k0luca01@louisville.edu
Contact: Belinda Coy 502-852-8450 bgcoy001@louisville.edu

Locations
United States, Kentucky
Pediatric Hematology/Oncology University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Kenneth Lucas, M.D.    502-852-8450    k0luca01@louisville.edu   
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Kenneth Lucas, M.D. University of Louisville
  More Information

Additional Information:
No publications provided

Responsible Party: Kenneth Lucas, Division Cheif, University of Louisville
ClinicalTrials.gov Identifier: NCT01969942     History of Changes
Other Study ID Numbers: 13.0176
Study First Received: October 21, 2013
Last Updated: October 28, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Louisville:
Ewings sarcoma
rhabdomyosarcoma

Additional relevant MeSH terms:
Rhabdomyosarcoma
Sarcoma
Sarcoma, Ewing
Myosarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue
Osteosarcoma

ClinicalTrials.gov processed this record on November 25, 2014