NCT00068523

Ultraviolet-B Light Therapy and Allogeneic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies

Immunomodulation by Ultraviolet B-Irradiation (UVB) to Facilitate Allogeneic Stem Cell Transplantation for Treatment of Hematologic Malignancies

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Myeloproliferative Disorders
• Leukemia
• Lymphoma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic/Myeloproliferative Diseases

Interventions

Type	Name	Description
BIOLOGICAL	anti-thymocyte globulin	anti-thymocyte globulin IV over 4 hours on days -2 to -1
DRUG	cyclophosphamide	cyclophosphamide IV over 1 hour on days -3 to -2
DRUG	cyclosporine	oral cyclosporine on days -1 to 100
DRUG	fludarabine phosphate	fludarabine IV over 30 minutes on days -8 to -4
DRUG	methylprednisolone	methylprednisolone (oral or IV) on days 5-15
PROCEDURE	UV light therapy	Patients undergo ultraviolet-B (UVB) light therapy every other day between days -10 and -2 for a total of 3 days. 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.
PROCEDURE	allogeneic bone marrow transplantation
PROCEDURE	peripheral blood stem cell transplantation	Allogeneic peripheral blood stem cell (PBSC) transplantation: Patients undergo PBSC transplantation on day 0.

Timeline

• Start date: 2003-06-01
• Primary completion: 2004-03-01
• First posted: 2003-09-11
• Last updated: 2020-07-27

Locations

1 site across 1 country: United States