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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
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 belowSelect...
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:Select...
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
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
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
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,982 Total Patients Enrolled
Elizabeth A PoplinPrincipal InvestigatorRutgers Cancer Institute of New Jersey
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently experiencing symptoms of pancreatitis with high amylase or lipase levels.I do not have HIV, hepatitis B, or hepatitis C.My pancreatic cancer cannot be surgically removed, but it can be treated with an ultrasound-guided injection.I will use birth control during and for four months after the study.I can avoid close contact with high-risk individuals for 3 weeks after getting the PANVAC-V vaccine.I have an autoimmune disease like lupus, Sjogren's, or Hashimoto's.I do not have any other serious illnesses that would make treatment unsafe for me.Your creatinine level is not higher than 1.5 times the normal level for the testing facility.There should be no signs of casts in the urine test.Your AST and ALT levels in your blood are not more than 2.5 times the normal limit at the testing facility.I am not allergic to smallpox vaccines, chickenpox vaccines, GM-CSF, or eggs.I do not have any serious illnesses that are not under control.Your hemoglobin level is 8 grams per deciliter or higher.I do not have severe skin conditions like extensive eczema, psoriasis, or open wounds.I have had radiation therapy targeting my pancreas.You must have at least 100,000 platelets per microliter of blood.Your blood clotting time is within the normal range for the hospital where you are being treated.Your total bilirubin level should be within a certain range set by the hospital.You have a low count of a type of white blood cells called leukocytes.You have enough infection-fighting white blood cells in your body.I do not have brain metastases.I am fully active and can carry on all pre-disease activities without restriction.My cancer is confirmed as pancreatic adenocarcinoma through testing.I haven't had chemotherapy or radiotherapy in the last 4 weeks, or I've recovered from their side effects.I haven't taken systemic steroids in the last 28 days, but I may have used topical or inhaled steroids.Your amylase/lipase levels are not more than 1.5 times the normal limit at the study site.My urine protein levels are low or normal.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (vaccine therapy, sargramostim)
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.
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