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| Sponsor: | Case Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00054236 |
Purpose
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 Drug: methylprednisolone |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: 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 2011 (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.
Eligibility| 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
Contacts and Locations| United States, Ohio | |
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Principal Investigator: | Brenda Cooper, MD | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center |
More Information
| Responsible Party: | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00054236 History of Changes |
| Other Study ID Numbers: | CWRU6Y01, P30CA043703, CWRU6Y01, 12-01-32J |
| Study First Received: | February 5, 2003 |
| Last Updated: | September 6, 2011 |
| Health Authority: | United States: Federal Government |
|
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 primary myelofibrosis essential thrombocythemia refractory multiple myeloma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma |
|
Anemia Anemia, Aplastic Neoplasms Leukemia Lymphoma Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Lymphoma, Large-Cell, Immunoblastic Myelodysplastic-Myeloproliferative Diseases Hematologic Diseases Bone Marrow Diseases |
Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hemorrhagic Disorders Precancerous Conditions Lymphoma, Non-Hodgkin Antilymphocyte Serum Cyclophosphamide |