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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00045305 |
RATIONALE: Photopheresis treats the patient's blood with drugs and ultraviolet light outside the body and kills the white blood cells. Giving photopheresis, pentostatin, and radiation therapy before a donor bone marrow or stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving pentostatin before transplant and cyclosporine or mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving pentostatin together with photopheresis and total-body irradiation work before donor bone marrow transplant in treating patients with myelodysplastic syndromes.
Condition | Intervention | Phase |
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Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: cyclosporine Drug: methotrexate Drug: methoxsalen Drug: mycophenolate mofetil Drug: pentostatin Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Reduced Intensity Allogeneic Bone Marrow Transplant for the Treatment of Myelodysplastic Syndromes |
Estimated Enrollment: | 33 |
Study Start Date: | May 2005 |
Estimated Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study within 2.1 years.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
One of the following cytologically proven myelodysplastic syndromes
International Prognosis Scoring System (IPSS) score of at least 0.5 OR red cell transfusion dependence for at least 6 months (2 units per month)
Suitable HLA-matched donor (related or unrelated) available
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
No iron deficiency
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Arizona | |
Mayo Clinic Scottsdale | Recruiting |
Scottsdale, Arizona, United States, 85259-5499 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
United States, Florida | |
Mayo Clinic - Jacksonville | Recruiting |
Jacksonville, Florida, United States, 32224 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
United States, Massachusetts | |
Tufts-NEMC Cancer Center | Recruiting |
Boston, Massachusetts, United States, 02111 | |
Contact: Kellie A. Sprague 617-636-6100 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
United States, Ohio | |
Jewish Hospital Cancer Center | Recruiting |
Cincinnati, Ohio, United States, 45236 | |
Contact: E. Randolph Broun, MD 513-686-5482 | |
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104-4283 | |
Contact: Clinical Trials Office - Abramson Cancer Center of the Univers 800-474-9892 | |
United States, South Dakota | |
Avera Cancer Institute | Recruiting |
Sioux Falls, South Dakota, United States, 57105 | |
Contact: Loren K. Tschetter, MD 605-328-8000 | |
Medical X-Ray Center, PC | Recruiting |
Sioux Falls, South Dakota, United States, 57105 | |
Contact: Loren K. Tschetter, MD 605-328-8000 | |
Sanford Cancer Center at Sanford USD Medical Center | Recruiting |
Sioux Falls, South Dakota, United States, 57117-5039 | |
Contact: Clinical Trials Office - Sanford Cancer Center 605-328-1367 |
Study Chair: | Selina M. Luger, MD | University of Pennsylvania |
Study ID Numbers: | CDR0000256928, ECOG-E1902 |
Study First Received: | September 6, 2002 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00045305 |
Health Authority: | Unspecified |
chronic myelomonocytic leukemia de novo myelodysplastic syndromes previously treated myelodysplastic syndromes refractory anemia refractory anemia with excess blasts |
refractory anemia with ringed sideroblasts secondary myelodysplastic syndromes atypical chronic myeloid leukemia myelodysplastic/myeloproliferative disease, unclassifiable |
Pentostatin Cyclosporine Precancerous Conditions Chronic myelogenous leukemia Clotrimazole Refractory anemia Chronic myelomonocytic leukemia Miconazole Cyclosporins Leukemia Preleukemia Anemia, Refractory Methoxsalen Mycophenolate mofetil Neoplasm Metastasis |
Methotrexate Myelodysplastic syndromes Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Myelodysplastic Syndromes Myelodysplasia Tioconazole Anemia Myeloproliferative Disorders Leukemia, Myeloid Folic Acid Myelodysplastic myeloproliferative disease Leukemia, Myelogenous, Chronic, BCR-ABL Positive Anemia, Refractory, with Excess of Blasts |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Pathologic Processes Antifungal Agents Syndrome Therapeutic Uses Abortifacient Agents |
Dermatologic Agents Nucleic Acid Synthesis Inhibitors Disease Neoplasms by Histologic Type Enzyme Inhibitors Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Pharmacologic Actions Neoplasms Photosensitizing Agents Radiation-Sensitizing Agents Antirheumatic Agents |