Status:
COMPLETED
Donor Natural Killer Cells After Donor Stem Cell Transplant in Treating Patients With Advanced Cancer
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Korea Research Institute of Bioscience & Biotechnology
Conditions:
Brain and Central Nervous System Tumors
Chronic Myeloproliferative Disorders
Eligibility:
All Genders
15-75 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Giving an infusion of natural killer cells from a donor after a donor stem cell transplant may help kill any remaining cancer cells after the transplant. PURPOSE: This phase I/II trial is ...
Detailed Description
OBJECTIVES: Primary * To assess the safety of donor natural killer (NK) cell infusion after HLA-mismatched/haploidentical allogeneic hematopoietic stem cell transplantation from a familial donor in ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of a malignant disorder (hematologic malignancies or solid tumors)
- Advanced disease
- Has undergone prior allogeneic hematopoietic stem cell transplantation (HSCT) from an HLA-mismatched/haploidentical familial donor
- Progressive or recurrent disease, as defined by any of the following (phase II):
- Peripheral blood blast \> 20% with bone marrow aspirate showing \> 5% leukemic cells (in patients with acute leukemia)
- Detection of metaphases in the marrow with the same clonal cytogenetic abnormalities as identified before HSCT (or by FISH markers, if appropriate) (in patients with acute leukemia or high-risk myelodysplastic syndromes \[MDS\])
- Persistent cytopenia with bone marrow aspirate showing various degrees of dysplasia involving ≥ 1 cell lineage (in patients with high-risk MDS)
- Enlargement of pre-existing measurable lesions by 20% according to RECIST criteria (in patients with solid tumors or lymphoma)
- Appearance of new metastatic lesions, including pleural effusion or ascites, radiologically typical for metastases or confirmed as such by cytology (in patients with solid tumors or lymphoma)
- Measurable disease (phase II)
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Total bilirubin \< 3.0 mg/dL
- AST \< 5 times upper limit of normal
- Creatinine \< 3 mg/dL
- Not pregnant or nursing
- No clinically evident cardiac or pulmonary failure
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00823524
Start Date
January 1 2009
End Date
February 1 2013
Last Update
February 20 2013
Active Locations (1)
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1
University of Ulsan, Asan Medical Center
Seoul, South Korea, 138-736