Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112645
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2005-06-02
Brief Title:
Donor Stem Cell Transplant in Treating Young Patients With Relapsed or Refractory Solid Tumors
Sponsor:
Milton S Hershey Medical Center
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 bodys 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
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
Detailed Description:
OBJECTIVES
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
OUTLINE
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
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
OUTLINE
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000430441 | REGISTRY | PDQ Physician Data Query | None |