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

NCT ID: NCT00823524

Last Updated: 2013-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2013-02-28

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

donor NK cell infusion

give patients donor-derived NK cells 2 to 3 weeks after HLA-haploidentical hematopoietic cell transplantation

Group Type: EXPERIMENTAL

donor natural killer cell infusion

Intervention Type: BIOLOGICAL

give patients donor-derived NK cells 2 to 3 weeks after HLA-haploidentical hematopoietic cell transplantation

Interventions

donor natural killer cell infusion

give patients donor-derived NK cells 2 to 3 weeks after HLA-haploidentical hematopoietic cell transplantation

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of a malignant disorder (hematologic malignancies or solid tumors)

• Advanced disease
• Has undergone prior allogeneic hematopoietic stem cell transplantation (HSCT) from an HLA-mismatched/haploidentical familial donor
• Progressive or recurrent disease, as defined by any of the following (phase II):

• Peripheral blood blast > 20% with bone marrow aspirate showing > 5% leukemic cells (in patients with acute leukemia)
• Detection of metaphases in the marrow with the same clonal cytogenetic abnormalities as identified before HSCT (or by FISH markers, if appropriate) (in patients with acute leukemia or high-risk myelodysplastic syndromes [MDS])
• Persistent cytopenia with bone marrow aspirate showing various degrees of dysplasia involving ≥ 1 cell lineage (in patients with high-risk MDS)
• Enlargement of pre-existing measurable lesions by 20% according to RECIST criteria (in patients with solid tumors or lymphoma)
• Appearance of new metastatic lesions, including pleural effusion or ascites, radiologically typical for metastases or confirmed as such by cytology (in patients with solid tumors or lymphoma)
• Measurable disease (phase II)

PATIENT CHARACTERISTICS:

• Karnofsky performance status 70-100%
• Total bilirubin < 3.0 mg/dL
• AST < 5 times upper limit of normal
• Creatinine < 3 mg/dL
• Not pregnant or nursing
• No clinically evident cardiac or pulmonary failure

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea Research Institute of Bioscience & Biotechnology

OTHER_GOV

Sponsor Role: collaborator

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Kyoo-Hyung Lee

Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyoo H. Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

University of Ulsan, Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

AMC-UUCM-2008-0383

Identifier Type: -

Identifier Source: secondary_id

CDR0000632275

Identifier Type: -

Identifier Source: org_study_id