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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary:

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.

Sponsor: Asan Medical Center

Current Primary Outcome: 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:

  • Safety
  • Maximum number of donor natural killer (NK) cells that can be safely given


Current Secondary Outcome: 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: Clinical efficacy of donor NK cell infusion, in terms of tumor response, response duration, and survival

Information By: Asan Medical Center

Dates:
Date Received: January 14, 2009
Date Started: January 2009
Date Completion:
Last Updated: February 18, 2013
Last Verified: February 2013