| Eligibility |
Inclusion Criteria:
1. Male or female patients 18 years of age or older.
2. Patients must have histologically confirmed MCC that is Stage III (IIIB) or Stage IV,
as defined by the 2010 AJCC staging criteria for MCC. MCC of unknown primary is
allowed.
3. Prior systemic cytotoxic chemotherapies and/or novel immunotherapy treatments for MCC
are allowed. A wash-out period of 2 weeks prior to aNK treatment will be required.
4. ECOG performance status of 0-2.
5. Voluntary written informed consent must be given before performance of any
study-related procedure not part of normal medical care, with the understanding that
consent may be withdrawn by the patient at any time without prejudice to future
medical care.
6. Mandatory diagnostic biopsy and whole blood sample are required. The tumor biopsy
tissue will be analyzed for the presence of immune cells and will also undergo
genomic, transcriptomic, and proteomic profiling.
Exclusion Criteria:
1. Major surgery within 30 days before study entry.
2. Any of the following clinical laboratory values at the time of enrollment:
1. Absolute neutrophil count (ANC) < 1,000 cells/mm^3.
2. Platelets < 50,000 x 10^9/L.
3. Liver function abnormalities as indicated by ongoing hepatic enzyme elevation (e.g.
AST, ALT, GGT) > 2 x the ULN. Elevation related to direct tumor infiltration is
allowed.
4. Renal insufficiency as indicated by a creatinine level > 2 x the ULN.
5. Myocardial infarction within 6 months prior to enrollment or New York Hospital
Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe
uncontrolled arrhythmias, or electrocardiographic evidence of acute ischemia or
significant conduction system abnormalities in the opinion of the Investigator. Prior
to study entry any known abnormality on an electrocardiogram (ECG) must be determined
and documented by the Investigator to be not clinically significant to the patient
participation in this study.
6. Any condition, including laboratory abnormalities, that in the opinion of the
Investigator places the patient at unacceptable risk if he/she were to participate in
the study. This includes, but is not limited to, serious medical conditions or
psychiatric illness likely to interfere with participation in this clinical study.
7. Female patients who are pregnant or breastfeeding. Female patients of childbearing
potential must have a negative pregnancy test and agree to use adequate contraception
for the duration of the trial.
8. Patients with other malignancies or brain metastasis are not eligible; however, given
the frequent coexistence of MCC with other malignancies, the following exceptions are
allowed:
1. Patients who have been continuously disease-free for any solid tumor malignancy
>3 years prior to the time of enrollment.
2. Patients with basal cell carcinoma or squamous cell carcinoma.
3. Patients with prior history of in situ cancer (e.g., breast, melanoma, squamous
cells carcinoma of the skin, cervical).
4. Patients with prior history of prostate cancer that is not under active systemic
treatment (except hormonal therapy), but with undetectable PSA (<0.2 ng/mL).
5. Patients with chronic non-T-cell-based lymphocytic leukemia are eligible if they
have isolated lymphocytosis (Rai stage O) on the condition that they do not
require systemic treatment for their disease ["B" symptoms, Richter's
transformation, lymphocyte doubling time (<6 months) and they do not have
lymphadenopathy of hepatosplenomegaly].
6. Patients with non-T-cell-based lymphoma of any type or hairy cell leukemia are
eligible on the condition that they do not receive active systemic treatment for
their hematologic disease and are in complete remission as evidenced by PET/CT
scans and bone marrow biopsies for at least 3 months.
9. Patients on immunosuppressants, systemic corticosteroids, or any other investigational
product.
10. Patients unwilling to consent to analysis of their tumor tissue.
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