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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to first documented progression per recistv1.1, assessed up to 15 months
Awards & highlights
Study 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 belowSelect...
My neuroendocrine tumor tissue has tested positive for survivin.
Select...
My cancer is a neuroendocrine tumor from the gut, pancreas, or lung.
Select...
I can take care of myself with little help.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment to first documented progression per recistv1.1, assessed up to 15 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to first documented progression per recistv1.1, assessed up to 15 months
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 moreOther 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
Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
30,793 Total Patients Enrolled
Renuka V IyerPrincipal InvestigatorRoswell Park Cancer Institute
1 Previous Clinical Trials
132 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My neuroendocrine tumor tissue has tested positive for survivin.I am on full-dose anticoagulants and meet specific criteria.I am currently taking somatostatin analogues and can continue them during the study.I have not had cancer in the last 3 years, except for treated skin cancer or carcinoma-in-situ.I have HIV/AIDS or another serious illness.I do not have any conditions that cause frequent bleeding.I am taking more than 2 mg of dexamethasone or its equivalent daily.I haven't had immunotherapy for any cancer in the last 3 months.My cancer is a neuroendocrine tumor from the gut, pancreas, or lung.My cancer has worsened in the last 6 months, confirmed by scans.I had local therapy over 6 weeks ago and my treated cancer has grown since then.I can take care of myself with little help.I have a known autoimmune disorder.I do not have serious heart rhythm problems.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (SVN53-67/M57-KLH peptide vaccine, octreotide)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what ailments is SVN53-67/M57-KLH Peptide Vaccine commonly prescribed?
"SVN53-67/M57-KLH Peptide Vaccine is regularly employed as an intervention for hemopoietic stem cell transplant. Additionally, it can be used to combat side effects such as flushing, radiation syndrome and neutropenia among others."
Answered by AI
What additional research has been conducted on SVN53-67/M57-KLH Peptide Vaccine?
"Presently, 10 trials of SVN53-67/M57-KLH Peptide Vaccine are in the Phase 3 stage. Of these 58 studies focused on this vaccine, many are held at Trabzon and Florida locations; yet there exist 2,679 sites conducting research into this particular peptide immunogen."
Answered by AI
What is the recruitment quota for this medical experiment?
"Affirmative. As per the clinicaltrials.gov listing, this medical research is actively accepting patients since its posting on June 17th 2019 and latest update on August 10th 2022. A total of 14 participants are needed at a single location to complete the study requirements."
Answered by AI
Are there opportunities for individuals to partake in this trial?
"This investigation is presently recruiting participants as indicated on clinicaltrials.gov; its inception was June 17th 2019 and it has been recently updated August 10th 2022."
Answered by AI
Has the SVN53-67/M57-KLH Peptide Vaccine acquired FDA authorization?
"Our team at Power has classified SVN53-67/M57-KLH Peptide Vaccine as a safety level 1 due to being in the first clinical trial phase, where limited evidence of efficacy and security exists."
Answered by AI
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