Expired Study
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Cleveland, Ohio 44106


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00068523


Primary Contact:

Principal Investigator
Omer N. Koc, MD
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44106
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 14, 2017

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