Survivin Long Peptide Vaccine in Treating Patients With Metastatic Neuroendocrine Tumors

Inclusion Criteria:

• Have a Karnofsky performance status >= 70 or Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (i.e. the patient must be able to care for himself/herself with occasional help from others).

• Pathologically confirmed diagnosis of neuroendocrine tumor of gastrointestinal,pancreatic or lung origin.

• Patients who have been on somatostatin analogues (SSA) may continue to take SSAwhile on study treatment.

• Patients must have documented progression within the last six months on CT or MRIscans performed at least four weeks apart per RECIST v1.1 criteria. In the case ofretreatment, progression may be defined by the treating provider (e.g., clinical,radiographic, biochemical).

• Archival neuroendocrine tumor tissue must test positive for survivin presence byclinical immunohistochemistry prior to study enrollment

• Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (obtained within 14 days prior toenrollment).

• Platelets >= 100 x 10^9/L (obtained within 14 days prior to enrollment).

• Hemoglobin (Hgb) > 9g/dL (obtained within 14 days prior to enrollment).

• Plasma total bilirubin: =< 1.5 x upper limit of normal (ULN) (obtained within 14days prior to enrollment).

• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 4 x ULN (obtained within 14 days prior to enrollment).

• Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight [LMW]heparin) must meet the following criteria:

• No active bleeding or pathological condition that carries a high risk ofbleeding (e.g., tumor involving major vessels or known varices, which carries asignificant risk of bleeding in investigator's opinion).

• Creatinine =< 1.8 mg/dL (obtained within 14 days of enrollment).

• Participants of child-bearing potential must agree to use adequate contraceptivemethods (e.g., hormonal or barrier method of birth control; abstinence) prior tostudy entry and, have a negative pregnancy test prior to starting study treatment.Should a woman become pregnant or suspect she is pregnant while she or her partneris participating in this study, she should inform her treating physicianimmediately.

• Participant must understand the investigational nature of this study and sign anIndependent Ethics Committee/Institutional Review Board approved written informedconsent form prior to receiving any study related procedure.

Exclusion Criteria:

• The patient must not have received any immunotherapy for any malignancy,as long asit was > 3 months prior to study start.

• Patients with serious concurrent infection or medical illness, which in the treatingphysicians' opinion would jeopardize the ability of the patient to receive thetreatment outlined in this protocol with reasonable safety.

• Patients who are pregnant or breast-feeding.

• Patients with a concurrent or prior malignancy are ineligible unless they arepatients with curatively treated carcinoma-in-situ or basal cell carcinoma of theskin. Patients who have been free of disease (any prior malignancy) for at least 3years are eligible for this study.

• Known history of an autoimmune disorder.

• Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiencysyndrome (AIDS) related illness or other serious medical illness.

• Previous local therapy (e.g. chemo-embolization, bland, or radio-embolization) isallowed if completed > 6 weeks prior to randomization. For subjects who receivedlocal therapy prior to randomization, there must be documented growth of measurabledisease within the embolization field prior to study.

• Unwilling or unable to follow protocol requirements.

• Systemic corticosteroid therapy > 2 mg of dexamethasone or equivalent per day atstudy entry.

• Any condition which in the investigator's opinion deems the participant anunsuitable candidate to receive study drug.

• Received an investigational agent within 30 days prior to enrollment.

• Clinically significant cardiac arrhythmia, bradycardia, tachycardia that wouldcompromise patient safety or the outcome of the study.