Immunomodulation by Ultraviolet B-Irradiation (UVB) to Facilitate Allogeneic Stem Cell Transplantation for Treatment of Hematologic Malignancies
OBJECTIVES:
Primary
- Determine the safety of ultraviolet-B light therapy and allogeneic peripheral blood
stem cell transplantation in patients with hematologic malignancies by demonstrating
100-day mortality no greater than 15% and 1-year mortality no greater than 40%.
- Determine the frequency of treatment-related toxicity leading to death and frequency of
disease relapse resulting in death in patients treated with this regimen.
- Determine the incidence and severity of acute and chronic graft-versus-host disease in
patients treated with this regimen.
Secondary
- Determine the rates of donor allogeneic hematologic engraftment in patients treated
with this regimen.
- Determine the rate and quality of immune reconstitution in the peripheral blood and the
composition of immune cells in the skin before and after transplantation in these
patients.
- Determine the event-free and overall survival of patients treated with this regimen.
OUTLINE:
- Preparative regimen: Patients receive fludarabine IV over 30 minutes on days -8 to -4
and cyclophosphamide IV over 1 hour on days -3 to -2. Patients also receive
anti-thymocyte globulin IV over 4 hours on days -2 to -1. Patients undergo
ultraviolet-B (UVB) light therapy every other day between days -10 and -2 for a total
of 3 days.
- Allogeneic peripheral blood stem cell (PBSC) transplantation: Patients undergo PBSC
transplantation on day 0.
- Graft-versus-host disease prophylaxis: Patients receive oral cyclosporine on days -1 to
100 and methylprednisolone (oral or IV) on days 5-15.
- Posttransplantation UVB light therapy: Following PBSC transplantation, patients undergo
UVB light therapy twice weekly on week 1 (at least 1 day apart) and three times weekly
on weeks 2-4.
Donor lymphocyte infusion is performed per institutional guidelines for patients in whom
emerging donor chimerism post allogeneic PBSC transplantation is not progressing
(consistently below 50% during first 3 months), for whom donor chimerism is receding (to
below 25%) despite cessation of cyclosporine, or who relapse within 24 months after
allografting.
Patients are followed at least monthly for 3 months and then at 6, 12, 18, and 24 months.
PROJECTED ACCRUAL: A total of 23-36 patients will be accrued for this study.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study the effectiveness of combining ultraviolet-B light therapy with allogeneic stem cell transplantation in treating patients who have hematologic malignancies.
Patients are followed at least monthly for 3 months and then at 6, 12, 18, and 24 months.
No
Omer N. Koc, MD
Principal Investigator
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
United States: Federal Government
ICC7Y02
NCT00068523
June 2003
Name | Location |
---|---|
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |