Donor Stem Cell Transplant in Treating Young Patients With Relapsed or Refractory Solid Tumors
|ClinicalTrials.gov Identifier: NCT00112645|
Recruitment Status : Completed
First Posted : June 3, 2005
Last Update Posted : July 18, 2013
RATIONALE: A peripheral stem cell, bone marrow, or umbilical cord blood transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving busulfan and melphalan with or without antithymocyte globulin before transplant and cyclosporine with methylprednisolone or methotrexate after transplant may stop this from happening.
PURPOSE: This phase I trial is studying the side effects of donor stem cell transplant in treating young patients with relapsed or refractory solid tumors.
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific||Biological: anti-thymocyte globulin Drug: busulfan Drug: cyclosporine Drug: melphalan Drug: methotrexate Drug: methylprednisolone Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Procedure: umbilical cord blood transplantation||Phase 1|
- Determine the toxicity of allogeneic hematopoietic stem cell transplantation, in terms of the incidence of grade 3-4 acute graft-versus-host disease, in young patients with relapsed or refractory solid tumors.
- Determine the incidence of transplant-related mortality at 100 days post-transplantation in these patients.
- Conditioning: Patients receive busulfan IV or orally 4 times daily on days -8 to -5 (a total of 16 doses) and melphalan IV over 15-20 minutes on days -4 to -2. Patients with an unrelated donor also receive anti-thymocyte globulin IV on days -4 to -2.
- Allogeneic hematopoietic stem cell transplantation (SCT): Patients undergo allogeneic hematopoietic SCT on day 0.
- Post-transplant graft-versus-host disease (GVHD) prophylaxis: Patients who undergo cord blood SCT receive cyclosporine and methylprednisolone for graft-versus-host disease (GVHD) prophylaxis. Patients who undergo peripheral blood or bone marrow SCT receive cyclosporine and methotrexate (short course) for GVHD prophylaxis.
After completion of study treatment, patients are followed at 1, 3, 6, and 12 months and then annually thereafter.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 4 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study to Examine the Toxicity of Allogeneic Stem Cell Transplantation for Pediatric Solid Tumors With Relapsed or Therapy Refractory Disease|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||February 2011|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00112645
|United States, Pennsylvania|
|Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033-0850|
|Principal Investigator:||Kenneth G. Lucas, MD||Milton S. Hershey Medical Center|