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| Sponsors and Collaborators: |
UCSF Helen Diller Family Comprehensive Cancer Center 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 |
Drug: anti-thymocyte globulin Drug: busulfan Drug: etoposide Drug: fludarabine phosphate Drug: prednisone Drug: sargramostim Drug: tacrolimus Procedure: allogeneic hematopoietic stem cell transplantation Procedure: umbilical cord blood transplantation |
Phase I |
| Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
| MedlinePlus related topics: | Cancer Hodgkin's Disease Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma |
| 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 | Recruiting | ||||
| San Francisco, California, United States, 94115 | |||||
| Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 | |||||
| UCSF Helen Diller Family Comprehensive Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Thomas G. Martin, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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| Study ID Numbers: | CDR0000463370, UCSF-02253, UCSF-H24045-21269-04, UCSF-2207 |
| First Received: | March 15, 2006 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00304018 |
| Health Authority: | Unspecified |
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