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| Sponsor: | UCSF Helen Diller Family Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00304018 |
Purpose
RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and etoposide, before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and tacrolimus and prednisone after transplant may stop this from happening.
PURPOSE: This phase I trial is studying how well donor umbilical cord blood transplant works in treating patients with advanced hematologic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes |
Biological: anti-thymocyte globulin Biological: sargramostim Drug: busulfan Drug: etoposide Drug: fludarabine phosphate Drug: prednisone Drug: tacrolimus Procedure: allogeneic hematopoietic stem cell transplantation Procedure: umbilical cord blood transplantation |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Pilot Study of Umbilical Cord Blood Transplantation in Adult Patients With Advanced Hematopoietic Malignancies |
| Estimated Enrollment: | 10 |
| Study Start Date: | September 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot study.
After completion of study treatment, patients are followed periodically for approximately 2 years.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following advanced hematologic malignancies:
Acute myeloid leukemia (AML) meeting the following criteria:
Not expected to be curable with chemotherapy and meets ≥ 1 of the following criteria:
Myelodysplastic syndromes (MDS) with high-risk features
Acute lymphoblastic leukemia meeting the following criteria:
Not expected to be curable with chemotherapy and meets ≥ 1 of the following criteria:
Chronic myelogenous leukemia meeting ≥ 1 of the following criteria:
Blastic phase
Multiple myeloma meeting 1 of the following criteria:
Lymphoma meeting the following criteria:
One of the following subtypes:
Disease failed to respond to primary therapy, progressed, or recurred after prior therapy
Available umbilical cord blood (1-3 units) donor matching at ≥ 4 of 6 HLA antigens (A, B, and DR)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, California | |
| UCSF Helen Diller Family Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| Study Chair: | Thomas G. Martin, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000463370, UCSF-02253, UCSF-H24045-21269-04, UCSF-2207 |
| Study First Received: | March 15, 2006 |
| Last Updated: | July 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00304018 History of Changes |
| Health Authority: | United States: Federal Government |
|
adult acute myeloid leukemia with 11q23 (MLL) abnormalities recurrent adult acute myeloid leukemia secondary acute myeloid leukemia adult acute myeloid leukemia in remission adult acute erythroid leukemia (M6) adult acute megakaryoblastic leukemia (M7) adult acute monoblastic leukemia (M5a) adult acute monocytic leukemia (M5b) refractory multiple myeloma adult acute lymphoblastic leukemia in remission accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia chronic phase chronic myelogenous leukemia stage II multiple myeloma |
stage III multiple myeloma recurrent adult acute lymphoblastic leukemia recurrent adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma recurrent mantle cell lymphoma stage III mantle cell lymphoma recurrent adult Hodgkin lymphoma stage III adult Hodgkin lymphoma adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes |
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Anti-Inflammatory Agents Anti-Infective Agents Prednisone Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Tacrolimus Hormones Preleukemia Pathologic Processes Hemorrhagic Disorders Neoplasms by Site Therapeutic Uses Cardiovascular Diseases |
Etoposide Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents, Hormonal Hematologic Diseases Glucocorticoids Multiple Myeloma Neoplasms Fludarabine Antineoplastic Agents, Phytogenic Antimetabolites Vidarabine Precancerous Conditions Hematologic Neoplasms Immunologic Factors |