Survivin Long Peptide Vaccine in Treating Patients With Metastatic Neuroendocrine Tumors
Lung Atypical Carcinoid Tumor, Lung Typical Carcinoid Tumor, Metastatic Pancreatic Neuroendocrine Tumor
About this trial
This is an interventional treatment trial for Lung Atypical Carcinoid Tumor
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
- 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) > 9.0 g/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) =< 4.0 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.
Sites / Locations
- Roswell Park Cancer InstituteRecruiting
Arms of the Study
Arm 1
Experimental
Treatment (SVN53-67/M57-KLH peptide vaccine, octreotide)
Patients receive a SVN53-67/M57-KLH peptide vaccine in incomplete Freund's adjuvant SC and sargramostim SC on day 0. Treatment repeats every 2 weeks for up to 4 doses in the absence of disease progression or unacceptable toxicity. Patients also receive octreotide acetate IM on day 0. Cycles of octreotide acetate repeat every 28 days for 1 year in the absence of disease progression or unacceptable toxicity. Patients who remain free of tumor progression at 6 months and do not develop any regimen-related toxicity or serious adverse events will be eligible to receive additional doses of the vaccine and sargramostim every 3 months, for up to 1 year from the start of treatment.