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Donor Natural Killer Cells After Donor Stem Cell Transplant in Treating Patients With Advanced Cancer

This study has been completed.
Sponsor:
Collaborator:
Korea Research Institute of Bioscience & Biotechnology
Information provided by (Responsible Party):
Kyoo-Hyung Lee, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00823524
First received: January 14, 2009
Last updated: February 18, 2013
Last verified: February 2013
History of Changes

January 14, 2009
February 18, 2013
January 2009
February 2013   (final data collection date for primary outcome measure)
Safety [ Time Frame: 15 days to 1 year after transplantation ] [ Designated as safety issue: Yes ]
Safety will be evaluation in terms of transplantation outcomes as well as side effects of donor NK cell infusion
  • Safety [ Designated as safety issue: Yes ]
  • Maximum number of donor natural killer (NK) cells that can be safely given [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00823524 on ClinicalTrials.gov Archive Site
Clinical efficacy of donor NK cell infusion, in terms of tumor response, response duration, and survival [ Time Frame: 15 days to 1 year ] [ Designated as safety issue: No ]
achievement of CR of underlying disease, CR duration
Clinical efficacy of donor NK cell infusion, in terms of tumor response, response duration, and survival [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Donor Natural Killer Cells After Donor Stem Cell Transplant in Treating Patients With Advanced Cancer
Donor NK Cell Infusion for Progression/Recurrence of Underlying Malignant Disorders After HLA-haploidentical HCT - a Phase 1-2 Study

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.

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.
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
Biological: donor natural killer cell infusion
give patients donor-derived NK cells 2 to 3 weeks after HLA-haploidentical hematopoietic cell transplantation
Experimental: donor NK cell infusion
give patients donor-derived NK cells 2 to 3 weeks after HLA-haploidentical hematopoietic cell transplantation
Intervention: Biological: donor natural killer cell infusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
15 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00823524
CDR0000632275, AMC-UUCM-2008-0383
No
Kyoo-Hyung Lee, Asan Medical Center
Asan Medical Center
Korea Research Institute of Bioscience & Biotechnology
Principal Investigator: Kyoo H. Lee, MD Asan Medical Center
Asan Medical Center
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP