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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00569283
• Other study ID #: CDR0000577508
• Secondary ID: AMC-UUCM-2006-03
• Status: Completed
• Phase: Phase 1
• First received: December 6, 2007
• Last updated: March 25, 2013
• Start date: May 2007
• Est. completion date: December 2008

Study information

• Verified date: January 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 65 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Biological:
• therapeutic allogeneic lymphocytes

Locations

Country	Name	City	State
Korea, Republic of	Korea Research Institute of Bioscience and Biotechnology	Dajeon
Korea, Republic of	Asan Medical Center - University of Ulsan College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose of donor natural killer (NK) cells			Yes
Primary	Safety			Yes
Primary	Effectiveness of donor NK cell infusion in preventing tumor relapse and graft failure after HLA-haploidentical familial donor bone marrow transplantation			No