Ultraviolet-B Light Therapy and Allogeneic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells from a donor are rejected by the body's normal cells. Ultraviolet-B light therapy given before and after allogeneic stem cell transplantation may help prevent this from happening.
PURPOSE: Clinical trial to study the effectiveness of combining ultraviolet-B light therapy with allogeneic stem cell transplantation in treating patients who have hematologic malignancies.
|Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases||Biological: anti-thymocyte globulin Drug: cyclophosphamide Drug: cyclosporine Drug: fludarabine phosphate Drug: methylprednisolone Procedure: UV light therapy Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Immunomodulation by Ultraviolet B-Irradiation (UVB) to Facilitate Allogeneic Stem Cell Transplantation for Treatment of Hematologic Malignancies|
- Study the effectiveness of combining ultraviolet-B light therapy with allogeneic stem cell transplantation in treating patients who have hematologic malignancies. [ Time Frame: Patients are followed at least monthly for 3 months and then at 6, 12, 18, and 24 months. ]
|Study Start Date:||June 2003|
|Primary Completion Date:||March 2004 (Final data collection date for primary outcome measure)|
Biological: anti-thymocyte globulin
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00068523
|United States, Ohio|
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Omer N. Koc, MD||Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|