Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematologic Cancer
NCT ID: NCT00304018
Last Updated: 2013-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
5 participants
INTERVENTIONAL
2002-10-31
2009-03-31
Brief Summary
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PURPOSE: This phase I trial is studying how well donor umbilical cord blood transplant works in treating patients with advanced hematologic cancer.
Detailed Description
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Primary
* Determine the safety and feasibility of performing donor umbilical cord blood transplantation (UCBT) in patients with advanced hematologic malignancies, in terms of \> 80% engraftment rate at day 100 post-transplant and ≤ 50% transplant-related mortality.
Secondary
* Determine the toxicity of a myeloablative preparative regimen comprising busulfan, fludarabine, and etoposide prior to UCBT in these patients.
* Determine the neutrophil and platelet recovery in patients treated with this regimen.
* Determine the event-free and overall survival of patients treated with this regimen.
* Evaluate lineage-specific chimerism after UCBT and assess the contribution of each individual cord blood unit to post-transplantation hematopoiesis in these patients.
* Determine the incidence, severity, and timing of acute and chronic graft-vs-host disease in patients treated with this regimen.
OUTLINE: This is a pilot study.
* Preparative regimen: Patients receive fludarabine IV over 30 minutes on days -7 to -3, busulfan IV over 2 hours 4 times daily on days -7 and -4, etoposide IV over 4 hours on day -3, and anti-thymocyte globulin IV over 6 hours on days -2 and -1.
* Donor umbilical cord blood transplantation (UCBT): Patients undergo donor UCBT on day 0. Beginning on day 7, patients receive sargramostim (GM-CSF) IV or subcutaneously once daily until blood counts recover.
* Graft-vs-host disease prophylaxis: Patients receive tacrolimus IV continuously over 24 hours or orally twice daily beginning on day -2 and continuing until day 180 followed by a taper. Patients also receive oral prednisone twice daily on days 13-50 and then once daily on days 50-60, followed by a rapid taper.
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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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cord blood transplant
anti-thymocyte globulin
sargramostim
busulfan
etoposide
fludarabine phosphate
prednisone
tacrolimus
allogeneic hematopoietic stem cell transplantation
umbilical cord blood transplantation
Interventions
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anti-thymocyte globulin
sargramostim
busulfan
etoposide
fludarabine phosphate
prednisone
tacrolimus
allogeneic hematopoietic stem cell transplantation
umbilical cord blood transplantation
Eligibility Criteria
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Inclusion Criteria
* Not eligible for autologous stem cell transplantation
* Available umbilical cord blood (1-3 units) donor matching at ≥ 4 of 6 HLA antigens (A, B, and DR)
* Patients with an HLA-identical or 1 antigen-mismatched related donor OR a potential HLA-matched unrelated donor matching at \> 6/8 (A, B, C, DR) alleles are not eligible
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Creatinine \< 2.0 mg/dL
* Creatinine clearance \> 40 mL/min
* Bilirubin \< 2.0 mg/dL
* AST and alkaline phosphatase \< 3 times upper limit of normal
* Hepatitis C and active hepatitis B allowed if patient has ≤ grade 2 inflammation or fibrosis by liver biopsy
* Ejection fraction \> 40% by echocardiogram or MUGA
* DLCO \> 40% of predicted
* Not pregnant or nursing
* Negative pregnancy test
* No known HIV infection
* No active infection requiring ongoing antibiotic treatment
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
18 Years
55 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Thomas G. Martin, MD
Role: STUDY_CHAIR
University of California, San Francisco
Locations
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UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Countries
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Other Identifiers
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UCSF-02253
Identifier Type: -
Identifier Source: secondary_id
UCSF-H24045-21269-04
Identifier Type: -
Identifier Source: secondary_id
UCSF-2207
Identifier Type: -
Identifier Source: secondary_id
CDR0000463370
Identifier Type: -
Identifier Source: org_study_id