Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00436761
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2007-02-15
Brief Title:
Busulfan Melphalan and Antithymocyte Globulin Followed By Umbilical Cord Blood Transplant in Treating Young Patients With Refractory or Relapsed Malignant 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 Killer IG-Like Receptor KIR Mismatched Umbilical Cord Blood for Pediatric Patients With Malignant Solid Tumors
Status:
UNKNOWN
Status Verified Date:
2007-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Giving chemotherapy before a donor umbilical cord blood stem cell transplant helps stop the growth of tumor cells It also helps stop the patients immune system from rejecting the donors stem cells when they do not exactly match the patients blood The donated stem cells may replace the patients immune cells and help destroy any remaining tumor cells graft-versus-tumor effect Sometimes the transplanted cells from a donor can also make an immune response against the bodys normal cells Giving cyclosporine and methylprednisolone after the transplant may stop this from happening
PURPOSE This phase I trial is studying the side effects of busulfan melphalan and antithymocyte globulin followed by umbilical cord blood transplant in treating young patients with refractory or relapsed malignant solid tumors
PURPOSE This phase I trial is studying the side effects of busulfan melphalan and antithymocyte globulin followed by umbilical cord blood transplant in treating young patients with refractory or relapsed malignant solid tumors
Detailed Description:
OBJECTIVES
Examine the impact of the use of killer cell immunoglobulin-like receptor KIR-mismatched umbilical cord blood as a source of hematopoietic stem cells after busulfan melphalan and anti-thymocyte globulin in pediatric patients with relapsed or refractory solid tumors
Determine the toxicity of this regimen in terms of incidence of grade 3-4 acute graft-versus-host disease donorhost chimerism and cellular immunity against tumor cell lines in these patients
OUTLINE
Transplantation Patients receive busulfan orally or IV every 6 hours on days -8 to -5 anti-thymocyte globulin IV over 6 hours on days -4 to -1 and melphalan IV over 15-20 minutes on days -4 to -2 Patients undergo allogeneic umbilical cord blood stem cell infusion on day 0 Patients receive sargramostim GM-CSF subcutaneously beginning on day 7 and continuing until blood counts recover
Graft-vs-host disease prophylaxis Patients receive cyclosporine IV over 1 hour or orally twice daily on days -1 to 180 and methylprednisolone IV or orally once or twice daily on days 5 - 49
Blood samples are collected periodically for immunophenotyping and flow cytometric analysis including interferon gamma and other TH1 and TH2 cytokines
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
Examine the impact of the use of killer cell immunoglobulin-like receptor KIR-mismatched umbilical cord blood as a source of hematopoietic stem cells after busulfan melphalan and anti-thymocyte globulin in pediatric patients with relapsed or refractory solid tumors
Determine the toxicity of this regimen in terms of incidence of grade 3-4 acute graft-versus-host disease donorhost chimerism and cellular immunity against tumor cell lines in these patients
OUTLINE
Transplantation Patients receive busulfan orally or IV every 6 hours on days -8 to -5 anti-thymocyte globulin IV over 6 hours on days -4 to -1 and melphalan IV over 15-20 minutes on days -4 to -2 Patients undergo allogeneic umbilical cord blood stem cell infusion on day 0 Patients receive sargramostim GM-CSF subcutaneously beginning on day 7 and continuing until blood counts recover
Graft-vs-host disease prophylaxis Patients receive cyclosporine IV over 1 hour or orally twice daily on days -1 to 180 and methylprednisolone IV or orally once or twice daily on days 5 - 49
Blood samples are collected periodically for immunophenotyping and flow cytometric analysis including interferon gamma and other TH1 and TH2 cytokines
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
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 |
|---|---|---|---|
| PSCI-18589 | None | None | None |