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

NCT ID: NCT00068523

Last Updated: 2020-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

anti-thymocyte globulin

anti-thymocyte globulin IV over 4 hours on days -2 to -1

Intervention Type: BIOLOGICAL

cyclophosphamide

cyclophosphamide IV over 1 hour on days -3 to -2

Intervention Type: DRUG

cyclosporine

oral cyclosporine on days -1 to 100

Intervention Type: DRUG

fludarabine phosphate

fludarabine IV over 30 minutes on days -8 to -4

Intervention Type: DRUG

methylprednisolone

methylprednisolone (oral or IV) on days 5-15

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

allogeneic bone marrow transplantation

Intervention Type: PROCEDURE

peripheral blood stem cell transplantation

Allogeneic peripheral blood stem cell (PBSC) transplantation: Patients undergo PBSC transplantation on day 0.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed diagnosis of any of the following hematologic malignancies:

• Acute myeloid leukemia (AML) meeting any of the following criteria:

• First complete remission with high-risk karyotype

• Translocations t(15;17) allowed only if failed first-line induction therapy OR molecular evidence of persistent disease exists
• Translocations t(8;21) and inv(16) allowed only if failed first-line induction therapy
• Second or subsequent complete remission
• Minimal residual disease*
• Acute lymphoblastic leukemia meeting any of the following criteria:

• Failed induction therapy and has minimal residual disease* by salvage therapy
• First complete remission with high-risk karyotype (e.g., t[4;11] or t[9;22])
• Relapsed disease allowed provided a second or subsequent complete remission or minimal residual disease* is achieved
• Chronic myelogenous leukemia meeting any of the following criteria:

• Persistent or relapsed disease after 1 year of imatinib mesylate therapy
• Accelerated phase or blast crisis

• Blast crisis allowed after reinduction chemotherapy places disease in chronic phase
• Myelodysplastic syndromes meeting any of the following criteria:

• Refractory to medical management
• Cytogenetic abnormalities predictive of transformation into acute leukemia, including 5q-, 7q-, monosomy 7 and trisomy 8, or evidence of evolution to AML (e.g., refractory anemia with excess blasts (RAEB) or RAEB in transformation)
• Non-Hodgkin's lymphoma or Hodgkin's lymphoma meeting any of the following criteria:

• Beyond first complete remission or failed primary induction therapy and demonstrated sensitivity to therapy during the 6 months before transplantation
• Recurrent disease after autologous stem cell transplantation

• Must be at least 3 months posttransplantation
• Cyclin D1+ mantle cell lymphoma allowed after induction therapy and in first remission
• Multiple myeloma meeting either of the following criteria:

• Refractory or relapsed disease
• Residual disease after autologous transplantation
• Chronic lymphocytic leukemia (CLL) meeting all of the following criteria:

• Peripheral blood absolute lymphocyte count greater than 5,000/mm^3
• Small to moderate size lymphocytes and less than 55% pro-lymphocytes, atypical lymphocytes, or lymphoblasts morphologically
• B-cell or T-cell
• Myeloproliferative disorders, including myelofibrosis

• Philadelphia negative
• Availability of a HLA-A, B, and DR identical family donor OR HLA-A, B, and DR genetically matched unrelated donor
• Must meet 1 of the following criteria:

• At least 55 years of age at time of transplantation
• Received extensive prior therapy (i.e., more than 1 year of alkylator therapy or more than 2 different prior salvage regimens) or stem cell transplantation with myeloablative conditioning (either autologous or allogeneic)
• Presenting with comorbid condition (e.g., abnormal cardiac, pulmonary, or renal function and/or prior life-threatening infection) that precludes eligibility for enrollment in allogeneic transplantation protocols with full ablation conditioning
• No active CNS disease NOTE: *Defined as having no circulating blasts, absolute neutrophil count greater than 1,000/mm3 and less than 10% blasts in bone marrow at least 3 weeks after last systemic chemotherapy

PATIENT CHARACTERISTICS:

Age

• See Disease Characteristics
• Over 18

Performance status

• ECOG 0-2

Life expectancy

• At least 3 months

Hematopoietic

• See Disease Characteristics

Hepatic

• Bilirubin no greater than 2.0 mg/dL
• ALT/AST no greater than 4 times normal

Renal

• See Disease Characteristics
• Creatinine less than 2.0 mg/dL OR
• Creatinine clearance at least 50 mL/min

Cardiovascular

• See Disease Characteristics
• Normal cardiac function by echocardiogram or radionuclide scan
• Shortening fraction or ejection fraction at least 40% of normal

Pulmonary

• See Disease Characteristics
• DLCO at least 60%
• FEV_1 greater than 50% of predicted
• Pulse oximetry greater than 85%

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV negative
• No uncontrolled active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics
• At least 2 weeks since prior biologic response modifiers, signal transduction inhibitors, or monoclonal antibodies

Chemotherapy

• See Disease Characteristics
• At least 4 weeks since prior systemic conventional chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• Recovered from prior therapy
• No concurrent sun block/sunscreen or any cosmetic that may act as a sunscreen (e.g., lotion with SPF) on the days of scheduled ultraviolet-B light therapy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Principal Investigators

Omer N. Koc, MD

Role: PRINCIPAL_INVESTIGATOR

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Locations

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

ICC7Y02

Identifier Type: -

Identifier Source: org_study_id