Donor Natural Killer Cells After Donor Stem Cell Transplant in Treating Patients With Advanced Cancer
Status:
Completed
Sponsors
Asan Medical Center
Collaborators
Korea Research Institute of Bioscience & Biotechnology
Abstract:
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.
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.
- 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 21.
- Phase II: Patients receive an infusion of donor NK cells on days 14 and 21. After completion of study treatment, patients are followed periodically.
Last Verified:January/31/2013
First Submitted:January/13/2009
Estimated Enrollment Submitted:January/13/2009
First Posted:January/14/2009
Last Update Submitted:February/17/2013
Last Update Posted:February/19/2013
Actual Study Start Date:December/31/2008
Estimated Primary Completion Date:January/31/2013
Estimated Study Completion Date:January/31/2013
Condition or disease:Brain and Central Nervous System Tumors
Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Lymphoproliferative Disorder
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Unspecified Adult Solid Tumor, Protocol Specific
Intervention/treatment:
Biological: donor NK cell infusion
Phase:Phase 1/Phase 2
Study design:
Study Type:Interventional
Allocation:N/A
Primary Purpose:Treatment
Masking:None (Open Label)
Arm group:
ArmIntervention/treatment
Experimental: donor NK cell infusion
give patients donor-derived NK cells 2 to 3 weeks after HLA-haploidentical hematopoietic cell transplantation
Biological: donor NK cell infusion
give patients donor-derived NK cells 2 to 3 weeks after HLA-haploidentical hematopoietic cell transplantation
Eligibility Criteria:
Ages Eligible for Study:15 Years to 15 Years
Sexes Eligible for Study:All
Accepts Healthy Volunteers:Yes
Criteria:

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

Outcome:
Primary Outcome Measures
1. 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
1. 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
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