Lung Atypical Carcinoid TumorPhase 1NCT03879694

Survivin Long Peptide Vaccine in Treating Patients With Metastatic Neuroendocrine Tumors

A Phase 1 study testing Incomplete Freund's Adjuvant, Octreotide Acetate and Sargramostim in people with Lung Atypical Carcinoid Tumor and Lung Typical Carcinoid Tumor, run by Roswell Park Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Atypical Carcinoid Tumor, Lung Typical Carcinoid Tumor, Metastatic Pancreatic Neuroendocrine Tumor
What is being tested?: Incomplete Freund's Adjuvant, Octreotide Acetate and Sargramostim
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteUnited States
Study dates: 17 Jun 2019to 14 Mar 2025
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

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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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Roswell Park Cancer Institute
Buffalo, New York, 14263

Other trials in United States

About this study

Official title: A Phase I Study of Safety and Immunogenicity of Survivin Long Peptide Vaccine (SurVaxM) in Patients With Metastatic Neuroendocrine Tumors (NETs)

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.

Read the detailed description

PRIMARY OBJECTIVES:

To assess safety, tolerability and toxicity of SVN53-67/M57-KLH peptide vaccine (SurVaxM) in emulsion with incomplete Freund's adjuvant (montanide ISA 51) and given subcutaneously with sargramostim (granulocyte macrophage-colony-stimulating factor [GM-CSF]) in combination with a somatostatin analogue, octreotide acetate (Sandostatin LAR) in patients with survivin positive metastatic neuroendocrine tumors (NETs).

SECONDARY OBJECTIVES:

To determine clinical benefit (including complete response, partial response and stable disease as defined by Response Evaluation Criteria in Solid Tumors [RECIST] version [v]1.1) at 6 months, 9 months and 12 months from study entry.

II. To evaluate the immunogenicity of SurVaxM in NETs by measuring anti-survivin antibody levels and anti-tumor T-cell responses in peripheral blood.

III. To determine time to progression (TTP) compared to prior to study entry, in patients with metastatic NETs treated with SurVaxM.

EXPLORATORY OBJECTIVES:

To explore immune markers associated with clinical responses to SurVaxM in peripheral blood of NETs patients.

OUTLINE:

Patients receive a SVN53-67/M57-KLH peptide vaccine in incomplete Freund's adjuvant subcutaneously (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 intramuscularly (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.

After completion of study treatment, patients are followed up for 3 months.

Conditions: Lung Atypical Carcinoid Tumor, Lung Typical Carcinoid Tumor, Metastatic Pancreatic Neuroendocrine Tumor
Being tested: Incomplete Freund's Adjuvant, Octreotide Acetate, Sargramostim, SVN53-67/M57-KLH Peptide Vaccine
Medical subject headings: Adenoma, Islet Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Incomplete Freund's AdjuvantBiological
Also called Freund's Incomplete Adjuvant, IFA, ISA-51, Montanide ISA 51
Given SC
Octreotide AcetateDrug
Also called 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
Given IM
SargramostimBiological
Also called 23-L-Leucinecolony-Stimulating Factor 2, DRG-0012, Leukine, Prokine
Given SC
SVN53-67/M57-KLH Peptide VaccineBiological
Given SC

Study groups in NCT03879694
Study group	Role	What they receive
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. Receives: Biological: Incomplete Freund's Adjuvant; Drug: Octreotide Acetate; Biological: Sargramostim; Biological: SVN53-67/M57-KLH Peptide Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 15 months

Secondary outcomes (7)

Immunogenicity of SVN53-67/M57-KLH peptide vaccine
Survivin-specific CD8+ responses will be measured individually at baseline, 12 weeks and end of-study. These measures will be summarized by descriptive statistics (means, medians, quartiles, etc.). Confidence intervals will be constructed for the median and the mean. Exploratory graphical analysis will be used to discover associations among variables.
Measured: Baseline up to 15 months
Immunogenicity of SVN53-67/M57-KLH peptide vaccine
Anti-survivin antibody (humoral) responses will be measured individually at baseline, 12 weeks and end of-study. These measures will be summarized by descriptive statistics (means, medians, quartiles, etc.). Confidence intervals will be constructed for the median and the mean. Exploratory graphical analysis will be used to discover associations among variables.
Measured: Baseline up to 15 months
Rate of progression
Will be based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 on computed tomography scan and comparison rate prior to start of treatment.
Measured: Up to 15 months
Clinical benefit
Will be assessed with RECIST v1.1. Clinical Benefit (CB) is defined as number of patients having best overall response as complete response (CR), partial response (PR) or stable disease (SD). The estimated distribution of CB will be plotted using Kaplan Meier curves and reported with median survival and 95% confidence intervals if available.
Measured: Up to 12 months
Time to progression (TTP)
The TTP of each patient will be compared to TTP prior to study entry. The analysis will be descriptive and reported separately for each patient.
Measured: From enrollment to first documented progression per RECISTv1.1, assessed up to 15 months
Overall response rate (ORR)
Measured by RECIST v1.1.
Measured: Up to 15 months
Duration of response (DOR)
Measured by RECIST v1.1.
Measured: Up to 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jun 201914 Mar 2025

First posted19 Mar 2019
Study start17 Jun 2019
Primary completion15 Feb 2025
Study completion14 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lung Atypical Carcinoid TumorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03879694
Sponsor's protocol ID: I 79518
Other IDs: NCI-2019-00827, I 79518
Status last verified: Feb 2026
First submitted: 13 Mar 2019
Last updated: 6 Feb 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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