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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 2/first treatment to death due to any cause.at 1 year
Awards & highlights
Study Summary
This trial explores if a drug called Ampligen is safe & effective for pancreatic cancer patients.
Who is the study for?
This trial is for adults with locally advanced pancreatic adenocarcinoma who've completed at least 4 months of FOLFIRINOX treatment without disease progression. Participants must have a life expectancy of over 3 months, weigh at least 40kg, and have a Karnofsky Performance Status of 80 or higher. They should not be pregnant or breastfeeding and must agree to use contraception during the study.Check my eligibility
What is being tested?
The trial is testing Ampligen (Rintatolimod) to see if it's safe and effective when given after FOLFIRINOX therapy in patients with pancreatic cancer that hasn't spread beyond the local area. It compares outcomes between those receiving Ampligen and those who do not receive any additional treatment post-FOLFIRINOX.See study design
What are the potential side effects?
While specific side effects for Ampligen are not listed here, common side effects from similar treatments may include flu-like symptoms such as fever, chills, fatigue, nausea, headache; possible injection site reactions; and potential impacts on blood counts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ visit 2/first treatment to death due to any cause.at 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 2/first treatment to death due to any cause.at 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Duration of Response (DoR)
Objective Response Rate (ORR)
Overall Survival (OS)
+1 moreSide effects data
From 2021 Phase 2 trial • 19 Patients • NCT0340363473%
Fatigue
73%
Chills
40%
Hot flush
33%
Pyrexia
33%
Decreased appetite
27%
Nausea
20%
Gastrointestinal disorders **Any AE - Maximum Grade Seen Diarrhoea
20%
Headache
13%
Blood alkaline phosphatase increased
13%
Weight decreased
13%
Myalgia
13%
Vomiting
7%
Dehydration
7%
Dyspnoea
7%
Productive cough
7%
Pleural Effusion
7%
Insomnia
7%
Dizziness
7%
Hyperbilirubinemia
7%
Neoplasm (NOS)
7%
Death
7%
Asthenia
7%
Influenza like illness
7%
Mucosal infection
7%
Sinus congestion
7%
Hypotension
7%
Hyperhidrosis
7%
Dyspepsia
7%
Platelet count decreased
7%
Musculoskeletal pain
7%
Infusion related reaction
7%
Aspartate aminotransferase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Celecoxib, Interferon Alfa-2b, Rintatolimod)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Ampligen / rintatolimodExperimental Treatment1 Intervention
Subjects will receive rintatolimod [intravenous (IV)], up to 400 mg twice weekly until disease progression.
Group II: Control Group / No TreatmentActive Control1 Intervention
Subjects will be followed / no treatment until evidence of disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rintatolimod
2019
Completed Phase 2
~120
Find a Location
Who is running the clinical trial?
AIM ImmunoTech Inc.Lead Sponsor
14 Previous Clinical Trials
618 Total Patients Enrolled
Amarex Clinical ResearchOTHER
26 Previous Clinical Trials
1,592 Total Patients Enrolled
David R Strayer, MDStudy DirectorAIM ImmunoTech Inc.
6 Previous Clinical Trials
442 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of or currently have hepatitis A, B, or C.I need fluid removed from my abdomen at least every 2 weeks.I am mostly self-sufficient and active.I have previously received immunotherapy treatments.My diagnosis is a specific type of pancreatic or bile duct cancer.I weigh at least 40kg.My pancreatic cancer can be removed by surgery after FOLFIRINOX treatment.I have a positive test for the BRCA gene mutation.I have been treated with Ampligen® before.If I become pregnant while taking Ampligen®, I will report it immediately.I am a woman not yet two years post-menopausal or using birth control, and I have a recent negative pregnancy test.My pancreatic cancer cannot be removed by surgery.I do not have any serious uncontrolled infections requiring IV treatment.I cannot come back for scheduled treatments and check-ups.I haven't had serious bleeding, like stomach or brain bleeding, in the last 2 weeks.I am an adult over 18 and not pregnant or breastfeeding.I had cancer before, but it's either been treated or I've been cancer-free for 3 years.I haven't had a heart attack or severe heart issues in the last 6 months.I am not pregnant and will use birth control during and 90 days after the study.I have not had major surgery in the last 28 days and do not plan any during the study.I completed 4 months of FOLFIRINOX without my cancer getting worse.I am using or willing to use approved birth control methods during and after the study.My blood, liver, kidney, and clotting tests are within normal ranges.
Research Study Groups:
This trial has the following groups:- Group 1: Ampligen / rintatolimod
- Group 2: Control Group / No Treatment
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.
Has the FDA sanctioned Ampligen / rintatolimod for therapeutic applications?
"Our team at Power judged Ampligen / rintatolimod to have a safety rating of 2, as the drug has been tested in Phase 2 clinical trials and proven safe but not effective."
Answered by AI
What is the recruitment rate of participants for this research endeavor?
"Indeed, the clinicaltrials.gov website indicates that this trial is currently recruiting patients. It was announced on February 1st2023 and has been updated as of February 24th 2023. The study intends to enrol 90 individuals at one medical centre."
Answered by AI
Is this investigation presently open to new participants?
"Affirmative. Clinicaltrials.gov lists this medical trial as actively seeking participants with the original posting date of February 1st 2023, and an update on 24th of that month. For this study to be successful, 90 patients must be recruited from a single location."
Answered by AI
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