NCT00823524

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

Donor NK Cell Infusion for Progression/Recurrence of Underlying Malignant Disorders After HLA-haploidentical HCT - a Phase 1-2 Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 15 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain and Central Nervous System Tumors
• Chronic Myeloproliferative Disorders
• Leukemia
• Lymphoma
• Lymphoproliferative Disorder
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic/Myeloproliferative Neoplasms
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

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

Timeline

• Start date: 2009-01-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2009-01-15
• Last updated: 2013-02-20

Locations

1 site across 1 country: South Korea