Survivin Long Peptide Vaccine in Treating Patients With Metastatic Neuroendocrine Tumors

NCT03879694 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: I 79518NCI-2019-00827
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial studies the side effects of survivin long peptide vaccine and how it works with the immune system in treating patients with neuroendocrine tumors that have spread to other parts of the body (metastatic). Tumor cells make proteins that are not usually produced by normal cells. The body sees these proteins as not belonging and sends white blood cells called T cells to attack the tumor cells that contain these proteins. By vaccinating with small pieces of these proteins called peptides, the immune system can be made to kill tumor cells. Giving survivin long peptide vaccine to patients who have survivin expression in their tumors may create an immune response in the blood that is directed against neuroendocrine tumors.

Conditions

Lung Atypical Carcinoid Tumor; Lung Typical Carcinoid Tumor; Metastatic Pancreatic Neuroendocrine Tumor

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events of SVN53-67/M57-KLH peptide vaccine in combination with octreotide acetate in patients with neuroendocrine tumors

  Will be assessed with National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Will consider a toxicity to be an adverse event that is possibly, probably or definitely related to treatment. The maximum grade of toxicity for each category of interest will be recorded for each patient and the summary results will be tabulated by category and grade. Will be quantified using the observed rates of the adverse events, serious adverse events (SAE) and regimen limiting toxicities. Toxicity rates will be described using upper 1-sided 95% Jeffreys binomial confidence intervals.

  Up to 15 months

Secondary Outcomes (7)

• Immunogenicity of SVN53-67/M57-KLH peptide vaccine

  Baseline up to 15 months

• Immunogenicity of SVN53-67/M57-KLH peptide vaccine

  Baseline up to 15 months

• Rate of progression

  Up to 15 months

• Clinical benefit

  Up to 12 months

• Time to progression (TTP)

  From enrollment to first documented progression per RECISTv1.1, assessed up to 15 months

Other Outcomes (3)

• Serum levels of chromogranin A, serotonin and 5-HIAA

  Baseline up to 15 months

• Serum levels of serotonin and 5-HIAA

  Baseline up to 15 months

• Serum levels of 5-HIAA

  Baseline up to 15 months

Study Arms (1)

Treatment (SVN53-67/M57-KLH peptide vaccine, octreotide)

EXPERIMENTAL

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.

Biological: Incomplete Freund's Adjuvant; Drug: Octreotide Acetate; Biological: Sargramostim; Biological: SVN53-67/M57-KLH Peptide Vaccine

Interventions

Incomplete Freund's Adjuvant BIOLOGICAL

Given SC

Also known as: Freund's Incomplete Adjuvant, IFA, ISA-51, Montanide ISA 51, Montanide ISA-51

Treatment (SVN53-67/M57-KLH peptide vaccine, octreotide)

Octreotide Acetate DRUG

Given IM

Also known as: D-Phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[(1R,2R)-2-hydroxy-1-(hyroxymethyl)propyl]-L-cysteinamide, Cyclic (2->7)-disulfide, Acetate (Salt), Longastatin, Longastatina, Samilstin, Sandostatin, Sandostatin Lar Depot, Sandostatina, Sandostatine, SMS 201-995, SMS 201-995 AC

Treatment (SVN53-67/M57-KLH peptide vaccine, octreotide)

Sargramostim BIOLOGICAL

Given SC

Also known as: 23-L-Leucinecolony-Stimulating Factor 2, DRG-0012, Leukine, Prokine, rhu GM-CFS, Sagramostim, Sargramostatin

Treatment (SVN53-67/M57-KLH peptide vaccine, octreotide)

SVN53-67/M57-KLH Peptide Vaccine BIOLOGICAL

Given SC

Treatment (SVN53-67/M57-KLH peptide vaccine, octreotide)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• NeuroEndocrine Tumor Research Foundation (NETRF): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Adenoma, Islet Cell

Interventions

incomplete Freund's adjuvant; montanide ISA 51; Octreotide; Acetates; Salts; sargramostim; Colony-Stimulating Factors

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Inorganic Chemicals; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Proteins; Biological Factors

Study Officials

• Jasmeet Kaur, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 19, 2019
• Study Start: June 17, 2019
• Primary Completion: February 15, 2025
• Study Completion: March 14, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

US (1)