Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT03879694
Eligibility Criteria:
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 SSA while on study treatment.
* Patients must have documented progression within the last six months on CT or MRI scans performed at least four weeks apart per RECIST v1.1 criteria. In the case of retreatment, progression may be defined by the treating provider (e.g., clinical, radiographic, biochemical).
* Archival neuroendocrine tumor tissue must test positive for survivin presence by clinical immunohistochemistry prior to study enrollment
* Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (obtained within 14 days prior to enrollment).
* 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 14 days 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 of bleeding (e.g., tumor involving major vessels or known varices, which carries a significant 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 contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study 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 partner is participating in this study, she should inform her treating physician immediately.
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
Exclusion Criteria:
* The patient must not have received any immunotherapy for any malignancy,as long as it was \> 3 months prior to study start.
* Patients with serious concurrent infection or medical illness, which in the treating physicians' opinion would jeopardize the ability of the patient to receive the treatment 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 are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin. Patients who have been free of disease (any prior malignancy) for at least 3 years are eligible for this study.
* Known history of an autoimmune disorder.
* Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS) related illness or other serious medical illness.
* Previous local therapy (e.g. chemo-embolization, bland, or radio-embolization) is allowed if completed \> 6 weeks prior to randomization. For subjects who received local therapy prior to randomization, there must be documented growth of measurable disease 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 at study entry.
* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug.
* Received an investigational agent within 30 days prior to enrollment.
* Clinically significant cardiac arrhythmia, bradycardia, tachycardia that would compromise patient safety or the outcome of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03879694
Study Brief:
Protocol Section:
NCT03879694