Donor Natural Killer Cell Infusion in Preventing Relapse or Graft Failure in Patients Who Have Undergone Donor Bone Marrow Transplant

Sponsor

Asan Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00569283

Collaborator

(none)

Enrollment

Locations

19.1

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Giving donor natural killer cells to patients who have undergone donor bone marrow transplant may make the transplant work better and keep cancer cells from coming back.

PURPOSE: This phase I trial is studying the side effects and best dose of donor natural kill cells in preventing relapse or graft failure in patients who have undergone donor bone marrow transplant.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Biological: therapeutic allogeneic lymphocytes	Phase 1

Detailed Description

OBJECTIVES:

Primary

To ascertain the safety of donor natural killer (NK) cells, generated from peripheral blood hematopoietic stem cells, when given as a single intravenous infusion in patients who have undergone HLA-haploidentical familial donor bone marrow transplantation (BMT).
To determine the maximum tolerated dose of donor NK cells when given as a single infusion.

Secondary

To determine the effectiveness of donor NK cell infusion in preventing tumor relapse and graft failure after HLA-haploidentical familial donor BMT.

OUTLINE: Patients receive donor natural killer cells as a single infusion over 1 hour.

Cohorts of 3-6 patients receive escalating doses of natural killer cells until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 3 of 6 patients experience grade III toxicities or acute graft-vs-host disease.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Primary Purpose:

Treatment

Official Title:

Donor Natural Killer Cell Infusion for the Prevention of Relapse or Graft Failure After HLA-Haploidentical Familial Donor Bone Marrow Transplantation-A Phase I Study

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Outcome Measures

Primary Outcome Measures

Maximum tolerated dose of donor natural killer (NK) cells []
Safety []
Effectiveness of donor NK cell infusion in preventing tumor relapse and graft failure after HLA-haploidentical familial donor bone marrow transplantation []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Has undergone HLA-haploidentical familial donor bone marrow transplantation within the past 4-6 weeks
No manifestations of acute graft-vs-host disease at the time of planned donor natural killer cell infusion

PATIENT CHARACTERISTICS:

Karnofsky performance status 70-100%
Bilirubin < 2.0 mg/dL
AST < 3 times upper limit of normal
Creatinine < 2.0 mg/dL
Ejection fraction > 40% on MUGA scan

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea Research Institute of Bioscience and Biotechnology	Dajeon		Korea, Republic of	305-806
2	Asan Medical Center - University of Ulsan College of Medicine	Seoul		Korea, Republic of	138-736