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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: | NCT00003336 |
RATIONALE: Umbilical cord blood transplantation may allow doctors to give higher doses of chemotherapy or radiation therapy and kill more cancer cells.
PURPOSE: This phase II trial is studying how well umbilical cord blood transplantation works in treating patients with severe aplastic anemia, malignant thymoma, or myelodysplasia.
Condition | Intervention | Phase |
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Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Biological: anti-thymocyte globulin Drug: busulfan Drug: cyclophosphamide Drug: melphalan Drug: methylprednisolone Procedure: bone marrow ablation with stem cell support Procedure: umbilical cord blood transplantation Radiation: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Pilot Study of Unrelated Umbilical Cord Blood Transplantation in Patients With Severe Aplastic Anemia, Inborn Errors in Metabolism, or Inherited Hematologic Stem Cell Disorders |
Estimated Enrollment: | 90 |
Study Start Date: | January 1998 |
OBJECTIVES:
OUTLINE: Patients are stratified according to weight (under 45 kg vs over 45 kg).
Patients receive high-dose chemotherapy and/or radiotherapy as a conditioning regimen beginning 6-9 days before the umbilical cord blood transplant (UCBT). The regimen varies according to the underlying cause of the anemia, but could include busulfan, cyclophosphamide or melphalan, anti-thymocyte globulin or methylprednisolone, and/or radiation therapy. One day after the conditioning regimen is completed, patients receive the UCBT.
Patients are followed weekly for 3 months, at 6 months, then every 6 months for 2.5 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 4-90 patients will be accrued for this study within 5 years.
Ages Eligible for Study: | up to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must meet at least two of the following criteria:
Following etiologies eligible:
The following etiologies only are eligible:
Following etiologies eligible:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Ohio | |
Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44106-7284 |
Study Chair: | Mary J. Laughlin, MD | Case Comprehensive Cancer Center |
Study ID Numbers: | CDR0000066307, CASE-CWRU-5Y97, NCI-G98-1431, CASE-5Y97 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003336 History of Changes |
Health Authority: | United States: Federal Government |
refractory anemia refractory anemia with ringed sideroblasts de novo myelodysplastic syndromes previously treated myelodysplastic syndromes |
secondary myelodysplastic syndromes atypical chronic myeloid leukemia myelodysplastic/myeloproliferative disease, unclassifiable childhood myelodysplastic syndromes |
Anti-Inflammatory Agents Melphalan Immunologic Factors Precancerous Conditions Aplastic Anemia Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Cyclophosphamide Hormones Neuroprotective Agents Refractory Anemia Leukemia |
Preleukemia Anemia, Refractory Anemia, Aplastic Neoplasm Metastasis Alkylating Agents Myelodysplastic Myeloproliferative Disease Methylprednisolone Hemisuccinate Antineoplastic Agents, Hormonal Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Myelodysplastic Syndromes Myeloproliferative Disorders Anemia Methylprednisolone acetate Leukemia, Myeloid |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Precancerous Conditions Immunologic Factors Antineoplastic Agents Methylprednisolone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Cyclophosphamide Hormones Neuroprotective Agents Leukemia Preleukemia |
Pathologic Processes Therapeutic Uses Syndrome Anemia, Aplastic Alkylating Agents Methylprednisolone Hemisuccinate Neoplasms by Histologic Type Disease Antineoplastic Agents, Hormonal Hematologic Diseases Myelodysplastic Syndromes Gastrointestinal Agents Anemia Myeloproliferative Disorders Methylprednisolone acetate |