Ultraviolet-B Light Therapy and Allogeneic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
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Histologically confirmed diagnosis of any of the following hematologic malignancies:
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Acute myeloid leukemia (AML) meeting any of the following criteria:
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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
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Second or subsequent complete remission
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Minimal residual disease*
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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
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Chronic myelogenous leukemia meeting any of the following criteria:
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Persistent or relapsed disease after 1 year of imatinib mesylate therapy
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Accelerated phase or blast crisis
- Blast crisis allowed after reinduction chemotherapy places disease in chronic phase
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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)
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Non-Hodgkin's lymphoma or Hodgkin's lymphoma meeting any of the following criteria:
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Beyond first complete remission or failed primary induction therapy and demonstrated sensitivity to therapy during the 6 months before transplantation
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Recurrent disease after autologous stem cell transplantation
- Must be at least 3 months posttransplantation
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Cyclin D1+ mantle cell lymphoma allowed after induction therapy and in first remission
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Multiple myeloma meeting either of the following criteria:
- Refractory or relapsed disease
- Residual disease after autologous transplantation
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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
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Myeloproliferative disorders, including myelofibrosis
- Philadelphia negative
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Availability of a HLA-A, B, and DR identical family donor OR HLA-A, B, and DR genetically matched unrelated donor
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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
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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
Trial design
Primary purpose
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Interventional model
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Data sourced from clinicaltrials.gov
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