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Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00054236 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Umbilical cord blood transplantation may be able to replace cells destroyed by chemotherapy.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy followed by umbilical cord blood transplantation in treating patients who have hematologic cancer or severe aplastic anemia.
Condition | Intervention | Phase |
---|---|---|
Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Biological: anti-thymocyte globulin Biological: filgrastim Drug: cyclophosphamide Drug: fludarabine phosphate Procedure: umbilical cord blood transplantation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Pilot Study Of Multiple Umbilical Cord Blood Unit Transplantation Following Non-Myeloablative Conditioning In Patients With Hematologic Disorders Or Severe Aplastic Anemia |
Estimated Enrollment: | 24 |
Study Start Date: | May 2002 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients receive a non-myeloablative conditioning regimen comprising fludarabine IV over 30 minutes on days -8 to -4, cyclophosphamide IV over 2 hours on days -3 to -2, and anti-thymocyte globulin (ATG) IV over at least 4 hours on days -2 to -1. Patients unable to tolerate ATG may receive methylprednisolone IV over 1 hour on days -3 to -1.
Patients undergo multiple unit umbilical cord blood transplantation on days 0-1. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 7 and continuing until blood counts recover.
Patients are followed monthly for 6 months; at 9, 12, 14, 16, 18, and 24 months; and then annually thereafter.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 2 years.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
One of the following histologically confirmed diagnoses:
Acquired severe aplastic anemia
Meets at least 2 of the following criteria:
Acute myeloid leukemia (AML), meeting 1 of the following criteria:
In first complete remission (CR) with any of the following high-risk features:
Acute lymphoblastic leukemia, meeting 1 of the following criteria:
In first CR with the following high-risk features:
Chronic myelogenous leukemia
Myelodysplastic syndromes meeting 1 of the following criteria:
= 5q- = 7q-
Evidence of evolution to AML (e.g., refractory anemia with excess blasts [RAEB], or RAEB in transformation)
Chronic lymphocytic leukemia
Multiple myeloma
Hodgkin's lymphoma
Non-Hodgkin's lymphoma (NHL)
Myeloproliferative disorders
Allografting required unless grade 3 or greater myelofibrosis by bone marrow biopsy
Organ toxicity or infection precluding eligibility for allogeneic transplantation with full ablation conditioning
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No other concurrent investigational agents that would preclude study participation or increase risk to patient
United States, Ohio | |
Case Comprehensive Cancer Center | Recruiting |
Cleveland, Ohio, United States, 44106-5065 | |
Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422 | |
Geauga Regional Hospital | Recruiting |
Cleveland, Ohio, United States, 44024 | |
Contact: Tamila Kindwall-Keller 440-285-6000 | |
Lake/University Ireland Cancer Center | Recruiting |
Cleveland, Ohio, United States, 44060 | |
Contact: Tamila Kindwall-Keller 440-205-5755 | |
Mercy Cancer Center at Mercy Medical Center | Recruiting |
Cleveland, Ohio, United States, 44708 | |
Contact: Tamila Kindwall-Keller 330-430-2788 | |
University Suburban Health Center | Recruiting |
Cleveland, Ohio, United States, 44121 | |
Contact: Tamila Kindwall-Keller 216-844-3871 | |
UHHS Chagrin Highlands Medical Center | Recruiting |
Cleveland, Ohio, United States, 44122 | |
Contact: Tamila Kindwall-Keller 216-292-1783 | |
UHHS Westlake Medical Center | Recruiting |
Cleveland, Ohio, United States, 44145 | |
Contact: Tamila Kindwall-Keller 440-250-2001 | |
Southwest General Health Center | Recruiting |
Cleveland, Ohio, United States, 44130 | |
Contact: Tamila Kindwall-Keller 440-816-8000 |
Study Chair: | Mary J. Laughlin, MD | Case Comprehensive Cancer Center |
Study ID Numbers: | CDR0000269915, CASE-CWRU-6Y01, CWRU-120132J, CASE-6Y01 |
Study First Received: | February 5, 2003 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00054236 History of Changes |
Health Authority: | Unspecified |
refractory anemia with excess blasts in transformation refractory anemia with excess blasts adult acute myeloid leukemia in remission childhood acute myeloid leukemia in remission recurrent adult acute myeloid leukemia recurrent childhood acute myeloid leukemia adult erythroleukemia (M6a) childhood acute erythroleukemia (M6) adult acute minimally differentiated myeloid leukemia (M0) childhood acute minimally differentiated myeloid leukemia (M0) adult acute megakaryoblastic leukemia (M7) childhood acute megakaryocytic leukemia (M7) adult acute lymphoblastic leukemia in remission childhood acute lymphoblastic leukemia in remission recurrent adult acute lymphoblastic leukemia |
recurrent childhood acute lymphoblastic leukemia accelerated phase chronic myelogenous leukemia chronic phase chronic myelogenous leukemia previously treated myelodysplastic syndromes refractory chronic lymphocytic leukemia stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma recurrent/refractory childhood Hodgkin lymphoma polycythemia vera chronic idiopathic myelofibrosis essential thrombocythemia refractory multiple myeloma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma |
Polycythemia Aplastic Anemia Lymphoma, Mantle-Cell Mantle Cell Lymphoma Follicular Lymphoma Refractory Anemia Acute Erythroblastic Leukemia Acute Myelocytic Leukemia Preleukemia Hemorrhagic Disorders Anemia, Refractory Acute Myeloid Leukemia, Adult Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large-Cell, Anaplastic Thrombocythemia, Hemorrhagic |
Hodgkin Disease Myelodysplastic Myeloproliferative Disease Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Blood Coagulation Disorders Myeloproliferative Disorders Leukemia, Myeloid Multiple Myeloma Leukemia, Erythroblastic, Acute B-cell Lymphomas Leukemia, Myeloid, Accelerated Phase Fludarabine |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Precancerous Conditions Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Paraproteinemias Cyclophosphamide Hemostatic Disorders Leukemia Preleukemia Hemorrhagic Disorders Pathologic Processes |
Therapeutic Uses Syndrome Anemia, Aplastic Cardiovascular Diseases Alkylating Agents Lymphoma Disease Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Anemia Myeloproliferative Disorders Vascular Diseases |