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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

No Placebo-Only Group

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.

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.

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 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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Clinical benefit

Duration of response (DOR)

Immunogenicity of SVN53-67/M57-KLH peptide vaccine

+3 more

Other study objectives

Serum levels of 5-HIAA

Serum levels of chromogranin A, serotonin and 5-HIAA

Serum levels of serotonin and 5-HIAA

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2006

Completed Phase 4

~850