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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00823524
Recruitment Status : Completed
First Posted : January 15, 2009
Last Update Posted : February 20, 2013
Sponsor:
Collaborator:
Korea Research Institute of Bioscience & Biotechnology
Information provided by (Responsible Party):
Kyoo-Hyung Lee, Asan Medical Center

Tracking Information
First Submitted Date  ICMJE January 14, 2009
First Posted Date  ICMJE January 15, 2009
Last Update Posted Date February 20, 2013
Study Start Date  ICMJE January 2009
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2012)
Safety [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: January 14, 2009)
  • Safety
  • Maximum number of donor natural killer (NK) cells that can be safely given
Change History Complete list of historical versions of study NCT00823524 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2012)
Clinical efficacy of donor NK cell infusion, in terms of tumor response, response duration, and survival [ Time Frame: 15 days to 1 year ]
achievement of CR of underlying disease, CR duration
Original Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2009)
Clinical efficacy of donor NK cell infusion, in terms of tumor response, response duration, and survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Donor Natural Killer Cells After Donor Stem Cell Transplant in Treating Patients With Advanced Cancer
Official Title  ICMJE Donor NK Cell Infusion for Progression/Recurrence of Underlying Malignant Disorders After HLA-haploidentical HCT - a Phase 1-2 Study
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.

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.
  • 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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  ICMJE Biological: donor natural killer cell infusion
give patients donor-derived NK cells 2 to 3 weeks after HLA-haploidentical hematopoietic cell transplantation
Study Arms  ICMJE 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2013)
47
Original Estimated Enrollment  ICMJE
 (submitted: January 14, 2009)
48
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00823524
Other Study ID Numbers  ICMJE CDR0000632275
AMC-UUCM-2008-0383
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kyoo-Hyung Lee, Asan Medical Center
Study Sponsor  ICMJE Asan Medical Center
Collaborators  ICMJE Korea Research Institute of Bioscience & Biotechnology
Investigators  ICMJE
Principal Investigator: Kyoo H. Lee, MD Asan Medical Center
PRS Account Asan Medical Center
Verification Date February 2013

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