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

Asan Medical Center

Status and phase: Completed; Phase 1

Conditions: Cancer

Treatments: Biological: therapeutic allogeneic lymphocytes

Study type: Interventional

Funder types: Other

Identifiers

NCT00569283

CDR0000577508

AMC-UUCM-2006-0383

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 estimated patients

Sex: All

Ages: Under 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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