Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005092
Status:
COMPLETED
Last Update Posted:
2018-10-26
First Post:
2000-04-06
Brief Title:
Chemotherapy Radiation Therapy and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase I Study of Photochemically Treated Donor T-Cell Supplements in HLA Haplotype Mismatched Hematopoietic Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2018-10
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 Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy used to kill tumor cells Sometimes the transplanted cells are rejected by the bodys normal tissues Transplanting donated cells that have been treated with psoralen may prevent this from happening
PURPOSE Phase I trial to study the effectiveness of chemotherapy radiation therapy and psoralen-treated donor cells in treating patients who are undergoing peripheral stem cell transplantation for hematologic cancer
PURPOSE Phase I trial to study the effectiveness of chemotherapy radiation therapy and psoralen-treated donor cells in treating patients who are undergoing peripheral stem cell transplantation for hematologic cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of T-cells photochemically treated with psoralen and ultraviolet A given with peripheral stem cell transplantation in patients with hematologic malignancies or bone marrow failure myelodysplastic syndrome II Assess the toxicity of this treatment in these patients III Evaluate this regimen in terms of prevention of graft versus host disease and control of malignancy in these patients
OUTLINE This is a dose escalation multicenter study of T-cells photochemically treated with psoralen and ultraviolet A Patients receive thiotepa IV over 2 hours on day 1 cyclophosphamide IV over 2 hours on days 2 and 3 and whole body radiotherapy on days 5-8 Patients undergo preserved stem cell or bone marrow allogeneic transplant plus psoralen treated T-cell allogeneic transplant on day 9 Cohorts of 3-6 patients receive escalating doses of photochemically treated T-cells until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose limiting toxicities Patients are followed for 100 days
PROJECTED ACCRUAL A maximum of 37 patients will be accrued for this study
OUTLINE This is a dose escalation multicenter study of T-cells photochemically treated with psoralen and ultraviolet A Patients receive thiotepa IV over 2 hours on day 1 cyclophosphamide IV over 2 hours on days 2 and 3 and whole body radiotherapy on days 5-8 Patients undergo preserved stem cell or bone marrow allogeneic transplant plus psoralen treated T-cell allogeneic transplant on day 9 Cohorts of 3-6 patients receive escalating doses of photochemically treated T-cells until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose limiting toxicities Patients are followed for 100 days
PROJECTED ACCRUAL A maximum of 37 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000067734 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |
| P30CA016672 | NIH | None | None |
| MDA-DM-98283 | OTHER | None | None |
| NCI-G00-1742 | None | None | None |