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Cancer Vaccine

Vaccine + Sargramostim for Pancreatic Cancer

Phase 1

Waitlist Available

Led By Elizabeth A Poplin

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 80%)

Patients must have histologically or cytologically confirmed pancreatic adenocarcinoma

Must not have

Active pancreatitis defined as clinically symptomatic hyperamylasemia and/or hyperlipasemia

Human immunodeficiency virus (HIV)-positive patients and patients with hepatitis B and C are ineligible because of likely reduced immune competence which could affect the ability to respond to the vaccine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a gene-modified virus vaccine in combination with a colony-stimulating factor to treat patients with locally advanced or metastatic pancreatic cancer.

Who is the study for?

This trial is for patients with advanced pancreatic cancer that can't be surgically removed. They should have a life expectancy of at least 6 months, good physical function, and adequate organ function. Participants must not have other serious illnesses or conditions that could interfere with the study, no recent chemotherapy or radiotherapy, no brain metastases, and they must agree to use contraception.

What is being tested?

The trial is testing vaccine therapy using gene-modified viruses alongside sargramostim (a substance boosting white blood cells) to see if this combination prompts the body's immune system to destroy cancer cells more effectively. The vaccines are injected directly into the tumor.

What are the potential side effects?

Possible side effects include reactions at the injection site, flu-like symptoms such as fever and chills, fatigue, nausea, bone pain due to increased white blood cells production by sargramostim. There may also be an increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active and can carry on all pre-disease activities without restriction.

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My cancer is confirmed as pancreatic adenocarcinoma through testing.

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My urine protein levels are low or normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently experiencing symptoms of pancreatitis with high amylase or lipase levels.

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I do not have HIV, hepatitis B, or hepatitis C.

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I have an autoimmune disease like lupus, Sjogren's, or Hashimoto's.

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I do not have any serious illnesses that are not under control.

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I do not have severe skin conditions like extensive eczema, psoriasis, or open wounds.

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I do not have brain metastases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

MTD of falimarev, defined as the dose level that 0/6 or 1/6 patients experience dose-limiting toxicity (DLT) and that at least 2/3 or 2/6 patients treated with the next higher dose have had DLT

Secondary study objectives

Cytokine production

Mean number of positive cells per high power field in the pancreas biopsy specimen

T cell proliferation

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 (vaccine therapy, sargramostim)Experimental Treatment4 Interventions

Patients receive falimarev vaccine intratumorally using endoscopic ultrasound guidance on day 1. Patients also receive inalimarev vaccine SC on day 1 and sargramostim SC on days 1-4. Patients then receive falimarev vaccine SC on days 15 and 29 and sargramostim SC on days 15-18 and 29-32 in the absence of unacceptable toxicity. Beginning on day 43, patients with stable or improving pancreatic cancer receive falimarev vaccine SC and sargramostim SC (given on the day of and for 3 days after each falimarev vaccination) monthly in the absence of disease progression or unacceptable toxicity. Beginning on day 71, patients with no irreversible or dose limiting toxicity, receive falimarev vaccine SC and sargramostim SC (given on the day of and for 3 days after each falimarev vaccination) monthly in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sargramostim

2006

Completed Phase 4

~880

0 / 9Eligibility criteria met