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

Phase 1

Completed

• Conditions: Brain and Central Nervous System Tumors; Lymphoma; Chronic Myeloproliferative Disorders; Myelodysplastic/Myeloproliferative Neoplasms; Unspecified Adult Solid Tumor, Protocol Specific; Leukemia; Lymphoproliferative Disorder; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes
• Interventions: Biological: donor natural killer cell infusion

• Registration Number: NCT00823524
• Lead Sponsor: Asan Medical Center

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 Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-14
• Study First Submitted QC: 2009-01-14
• Study First Posted: 2009-01-15
• Status Verified: 2013-02
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Last Update Submitted: 2013-02-18
• Last Update Posted: 2013-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
donor NK cell infusion	donor natural killer cell infusion	give patients donor-derived NK cells 2 to 3 weeks after HLA-haploidentical hematopoietic cell transplantation

Primary Outcome Measures

Name	Time	Method
Safety	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

Secondary Outcome Measures

Name	Time	Method
Clinical efficacy of donor NK cell infusion, in terms of tumor response, response duration, and survival	15 days to 1 year	achievement of CR of underlying disease, CR duration

Trial Locations

Locations (1)

University of Ulsan, Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of