Donor Natural Killer Cells After Donor Stem Cell Transplant in Treating Patients With Advanced Cancer
Study Details
Study Description
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 studying the side effects and best dose of donor natural killer cells when given after a donor stem cell transplant in treating patients with advanced cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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 patients with advanced malignant disorders.
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To determine the maximum number of donor NK cells that can be safely given to these patients.
Secondary
- To assess the clinical efficacy donor NK cell infusion, in terms of tumor response, response duration, and survival, in patients with progressive or recurrent malignant disorders.
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
- Phase I: Patients receive an infusion of donor natural killer (NK) cells on days 18 and
- Phase II: Patients receive an infusion of donor NK cells on days 14 and 21. After completion of study treatment, patients are followed periodically.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: donor NK cell infusion give patients donor-derived NK cells 2 to 3 weeks after HLA-haploidentical hematopoietic cell transplantation |
Biological: donor natural killer cell infusion
give patients donor-derived NK cells 2 to 3 weeks after HLA-haploidentical hematopoietic cell transplantation
|
Outcome Measures
Primary Outcome Measures
- Safety [15 days to 1 year after transplantation]
Safety will be evaluation in terms of transplantation outcomes as well as side effects of donor NK cell infusion
Secondary Outcome Measures
- Clinical efficacy of donor NK cell infusion, in terms of tumor response, response duration, and survival [15 days to 1 year]
achievement of CR of underlying disease, CR duration
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Diagnosis of a malignant disorder (hematologic malignancies or solid tumors)
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Advanced disease
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Has undergone prior allogeneic hematopoietic stem cell transplantation (HSCT) from an HLA-mismatched/haploidentical familial donor
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Progressive or recurrent disease, as defined by any of the following (phase II):
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Peripheral blood blast > 20% with bone marrow aspirate showing > 5% leukemic cells (in patients with acute leukemia)
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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])
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Persistent cytopenia with bone marrow aspirate showing various degrees of dysplasia involving ≥ 1 cell lineage (in patients with high-risk MDS)
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Enlargement of pre-existing measurable lesions by 20% according to RECIST criteria (in patients with solid tumors or lymphoma)
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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)
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Measurable disease (phase II)
PATIENT CHARACTERISTICS:
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Karnofsky performance status 70-100%
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Total bilirubin < 3.0 mg/dL
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AST < 5 times upper limit of normal
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Creatinine < 3 mg/dL
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Not pregnant or nursing
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No clinically evident cardiac or pulmonary failure
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Ulsan, Asan Medical Center | Seoul | Korea, Republic of | 138-736 |
Sponsors and Collaborators
- Asan Medical Center
- Korea Research Institute of Bioscience & Biotechnology
Investigators
- Principal Investigator: Kyoo H. Lee, MD, Asan Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000632275
- AMC-UUCM-2008-0383