Status:
COMPLETED
Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematologic Cancer
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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 cell...
Detailed Description
OBJECTIVES: Primary * Determine the safety and feasibility of performing donor umbilical cord blood transplantation (UCBT) in patients with advanced hematologic malignancies, in terms of \> 80% engr...
Eligibility Criteria
Inclusion
- 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:
- High-risk cytogenetics (-7, -7q, -5, -5q, t\[6,9\], t\[9,11\], complex, Philadelphia chromosome positive \[Ph+\])
- AML evolved from prior myelodysplasia
- AML secondary to prior chemotherapy
- Failed to achieve remission
- In second or subsequent remission
- Marrow blasts ≤ 10% (may be achieved using chemotherapy)
- Myelodysplastic syndromes (MDS) with high-risk features
- International Prognostic Scoring System (IPSS) score intermediate -2 or high-risk
- Marrow blasts ≤ 20% (may be achieved using chemotherapy)
- Acute lymphoblastic leukemia meeting the following criteria:
- Not expected to be curable with chemotherapy and meets ≥ 1 of the following criteria:
- High-risk cytogenetics (Ph+, t\[4,11\], 11q23 abnormalities, and monosomy 7)
- Required \> 1 induction course to achieve remission
- Failed to achieve remission
- In second or subsequent remission
- Marrow blasts ≤ 10% (may be achieved using chemotherapy)
- Chronic myelogenous leukemia meeting ≥ 1 of the following criteria:
- Accelerated phase
- Chronic phase refractory to imatinib mesylate
- Blastic phase
- Marrow blasts ≤ 10% (may be achieved using chemotherapy)
- Multiple myeloma meeting 1 of the following criteria:
- Stage II or III disease with \> first relapse or refractory disease
- Newly diagnosed disease with chromosome 13 abnormalities
- Lymphoma meeting the following criteria:
- One of the following subtypes:
- Diffuse large cell lymphoma
- Mantle cell lymphoma
- Peripheral T-cell lymphoma
- T-natural killer (NK) cell lymphoma
- Hodgkin's lymphoma
- Disease failed to respond to primary therapy, progressed, or recurred after prior therapy
- Patients who have failed autologous stem cell transplantation are eligible provided it has been \> 1 year since transplant
- No rapid progression of malignant disease
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00304018
Start Date
October 1 2002
End Date
March 1 2009
Last Update
August 14 2013
Active Locations (1)
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1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115