Status:
COMPLETED
Haploidentical NK Cell Infusion in Malignant Melanoma
Lead Sponsor:
Seoul National University Hospital
Conditions:
Melanoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
We hypothesized that haploidentical NK cells kill tumor cells more efficiently than autologous NK cells, based on the missing-self hypothesis. Therefore, we performed this study to investigate the rol...
Detailed Description
Human NK cells recognize and kill transformed cells in a MHC-unrestricted fashion, suggesting the role of cancer immunotherapy. However, autologous NK cells showed the lack of significant clinical eff...
Eligibility Criteria
Inclusion
- Histologically confirmed metastatic or relapsed malignant melanoma
- Patients who received prior chemotherapy or immunotherapy
- Patients who have at least one haploidentical donor willing to donate
- ECOG performance status 0 or 1
- 18 - 75 years
- At least one measurable disease according to the RECIST criteria
- Patients with 45% or more left ventricular ejection fraction
- Patients with 50% or more predicted DLCO
- Adequate bone marrow function: absolute neutrophil count ≥ 1.5 x 109/L; platelet count ≥ 100 x 109/L; and hemoglobin ≥ 9 g/dL
- Adequate liver function: total bilirubin ≤ 1.0 x upper limit of the normal range (ULN); AST/ALT ≤ 2.5 x ULN; and alkaline phosphatase ≤ 2.5 x ULN
- Adequate renal function: serum creatinine ≤ 1.0 x ULN or creatinine clearance ≥ 60 mL/min/1.73m2
- At least 3 months of expected survival
- Patients who signed informed consent
Exclusion
- Patients who received other chemotherapeutic agents within 30 days prior to study enrollment
- Patients who received adoptive cell therapy including hematopoietic stem cell transplantation
- Patients infected with HIV, HBV, or HCV
- Hypersensitivity to cyclophosphamide or interleukin-2
- Patients who received organ transplantation
- Patients who had arrhythmia or ischemic heart disease
- Pregnant or lactating women
- Patients with uncontrolled infection who did not respond to appropriate antimicrobial agents
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00846833
Start Date
February 1 2009
End Date
April 1 2012
Last Update
June 8 2012
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744