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| Sponsors and Collaborators: |
Ireland Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00068523 |
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.
| Condition | Intervention |
|---|---|
|
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 Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Immunomodulation by Ultraviolet B-Irradiation (UVB) to Facilitate Allogeneic Stem Cell Transplantation for Treatment of Hematologic Malignancies |
| Study Start Date: | June 2003 |
OBJECTIVES:
Primary
Secondary
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
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Acute lymphoblastic leukemia meeting any of the following criteria:
Chronic myelogenous leukemia meeting any of the following criteria:
Accelerated phase or blast crisis
Myelodysplastic syndromes meeting any of the following criteria:
Non-Hodgkin's lymphoma or Hodgkin's lymphoma meeting any of the following criteria:
Recurrent disease after autologous stem cell transplantation
Multiple myeloma meeting either of the following criteria:
Chronic lymphocytic leukemia (CLL) meeting all of the following criteria:
Myeloproliferative disorders, including myelofibrosis
Must meet 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Ohio | |
| Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44106 | |
| Principal Investigator: | Omer N. Koc, MD | Case Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000327713, CWRU-ICC-7Y02 |
| Study First Received: | September 10, 2003 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00068523 History of Changes |
| Health Authority: | United States: Federal Government |
|
refractory multiple myeloma accelerated phase chronic myelogenous leukemia adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission blastic phase chronic myelogenous leukemia recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia refractory chronic lymphocytic leukemia relapsing chronic myelogenous leukemia de novo myelodysplastic syndromes previously treated myelodysplastic syndromes recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult Burkitt lymphoma |
recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma refractory anemia with excess blasts in transformation refractory anemia with excess blasts secondary myelodysplastic syndromes Philadelphia chromosome negative chronic myelogenous leukemia chronic idiopathic myelofibrosis B-cell chronic lymphocytic leukemia T-cell large granular lymphocyte leukemia chronic phase chronic myelogenous leukemia recurrent adult Hodgkin lymphoma |
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Philadelphia Chromosome Anti-Inflammatory Agents Blast Crisis Cyclosporine Mantle Cell Lymphoma Cyclosporins Refractory Anemia Preleukemia Hemorrhagic Disorders Neoplasm Metastasis Myelodysplastic Myeloproliferative Disease Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Blood Coagulation Disorders Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative |
Leukemia, Myeloid Glucocorticoids Leukemia, Myeloid, Accelerated Phase Chronic Myelogenous Leukemia Fludarabine Lymphoma, Non-Hodgkin Precancerous Conditions Immunologic Factors Blood Protein Disorders Lymphoma, Follicular Sezary Syndrome Lymphoblastic Lymphoma Lymphoma, B-Cell Leukemia Cutaneous T-cell Lymphoma |
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Anti-Inflammatory Agents Anti-Infective Agents Antimetabolites, Antineoplastic Cyclosporine Molecular Mechanisms of Pharmacological Action Methylprednisolone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Cyclosporins Preleukemia Hemorrhagic Disorders Pathologic Processes Neoplasms by Site |
Therapeutic Uses Cardiovascular Diseases Dermatologic Agents Methylprednisolone Hemisuccinate Immunoproliferative Disorders Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Myeloproliferative Disorders Glucocorticoids Multiple Myeloma Neoplasms Fludarabine Antimetabolites Precancerous Conditions |