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

Asan Medical Center

Status and phase: Completed; Phase 2; Phase 1

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

Treatments: Biological: donor natural killer cell infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT00823524

CDR0000632275

AMC-UUCM-2008-0383

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 15 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

donor NK cell infusion

Experimental group

Description:

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

Treatment:

Biological: donor natural killer cell infusion