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Cancer Vaccine

Peptide Vaccine for Carcinoid Tumor

Phase 1
Recruiting
Led By Renuka V Iyer
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Archival neuroendocrine tumor tissue must test positive for survivin presence by clinical immunohistochemistry prior to study enrollment
Pathologically confirmed diagnosis of neuroendocrine tumor of gastrointestinal, pancreatic or lung origin
Must not have
Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS) related illness or other serious medical illness
Systemic corticosteroid therapy > 2 mg of dexamethasone or equivalent per day at study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to first documented progression per recistv1.1, assessed up to 15 months
Awards & highlights

Summary

This trial is testing a vaccine made of small pieces of protein to see if it can help the immune system to kill neuroendocrine tumor cells.

Who is the study for?
This trial is for patients with metastatic neuroendocrine tumors of the gastrointestinal tract, pancreas, or lungs. Participants must have normal kidney function, be relatively independent in daily activities, and show tumor progression recently. They can continue somatostatin analogues if already using them and must not be at high risk of bleeding.Check my eligibility
What is being tested?
The trial tests a survivin long peptide vaccine combined with immune system boosters to see if it can trigger the body's defense against tumor cells that produce abnormal proteins. It's for those whose tumors express survivin and aims to create an immune response targeting these cancer cells.See study design
What are the potential side effects?
Potential side effects may include typical reactions to vaccines such as soreness at the injection site, fever, fatigue, allergic responses or autoimmune-like symptoms due to the stimulation of the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My neuroendocrine tumor tissue has tested positive for survivin.
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My cancer is a neuroendocrine tumor from the gut, pancreas, or lung.
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I can take care of myself with little help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have HIV/AIDS or another serious illness.
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I am taking more than 2 mg of dexamethasone or its equivalent daily.
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I have a known autoimmune disorder.
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I do not have serious heart rhythm problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to first documented progression per recistv1.1, assessed up to 15 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to first documented progression per recistv1.1, assessed up to 15 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events of SVN53-67/M57-KLH peptide vaccine in combination with octreotide acetate in patients with neuroendocrine tumors
Secondary outcome measures
Clinical benefit
Duration of response (DOR)
Immunogenicity of SVN53-67/M57-KLH peptide vaccine
+3 more
Other outcome measures
Serum levels of 5-HIAA
Serum levels of chromogranin A, serotonin and 5-HIAA
Serum levels of serotonin and 5-HIAA

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (SVN53-67/M57-KLH peptide vaccine, octreotide)Experimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Octreotide Acetate
2016
Completed Phase 2
~260
Sargramostim
2008
Completed Phase 4
~850

Find a Location

Who is running the clinical trial?

NeuroEndocrine Tumor Research Foundation (NETRF)UNKNOWN
1 Previous Clinical Trials
50 Total Patients Enrolled
Roswell Park Cancer InstituteLead Sponsor
406 Previous Clinical Trials
31,513 Total Patients Enrolled
Renuka V IyerPrincipal InvestigatorRoswell Park Cancer Institute
1 Previous Clinical Trials
132 Total Patients Enrolled

Media Library

SVN53-67/M57-KLH Peptide Vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03879694 — Phase 1
Lung Carcinoid Tumor Research Study Groups: Treatment (SVN53-67/M57-KLH peptide vaccine, octreotide)
Lung Carcinoid Tumor Clinical Trial 2023: SVN53-67/M57-KLH Peptide Vaccine Highlights & Side Effects. Trial Name: NCT03879694 — Phase 1
SVN53-67/M57-KLH Peptide Vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03879694 — Phase 1
~1 spots leftby Dec 2024
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