Study on Ampligen Compared to No Treatment After FOLFIRINOX in Patients with Locally Advanced Pancreatic Cancer

Sponsor: AIM ImmunoTech Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05494697

Provider View

This clinical trial is testing the safety and effectiveness of Ampligen in patients with locally advanced pancreatic cancer who have already received FOLFIRINOX treatment. The study compares Ampligen to no additional treatment to see if it offers any benefits.

Patient Parameters

Program Overview

The purpose of this study is to find out if Ampligen is safe and effective for patients with locally advanced pancreatic cancer who have already been treated with FOLFIRINOX. The study will compare patients receiving Ampligen to those who do not receive any additional treatment after FOLFIRINOX.

Description

This is a Phase 2 study where participants are randomly assigned to receive either Ampligen or no additional treatment after completing FOLFIRINOX for locally advanced pancreatic cancer. The study is open-label, meaning both the researchers and participants know which treatment is being given. The main goal is to evaluate how well Ampligen works and how safe it is for patients in this situation.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with locally advanced pancreatic cancer that cannot be surgically removed.
  • Cancer must be measurable by standard criteria.
  • Completed at least four months of FOLFIRINOX treatment without disease progression, confirmed by scans.
  • Male or non-pregnant, non-breastfeeding female, aged 18 or older.
  • Negative pregnancy test for women who can have children, and agreement to use birth control during the study and for 90 days after.
  • Must weigh at least 40 kg (about 88 pounds).
  • Good overall health with a performance status score of 80 or higher.
  • Expected to live at least 3 more months according to the study doctor.
  • Adequate organ function based on specific blood tests.
  • Willing to sign informed consent and follow study requirements.

Exclusion Criteria

  • Have a different type of pancreatic cancer or cancer from another part of the body.
  • Cancer can be surgically removed after FOLFIRINOX treatment.
  • Previously treated with Ampligen.
  • Received experimental drugs within 6 weeks before the study.
  • History of another cancer unless treated and disease-free for at least 3 years.
  • Serious medical conditions or infections that are not controlled.
  • Positive for HIV or active hepatitis A, B, or C.
  • Significant bleeding or heart problems recently.
  • Pregnant or breastfeeding women.
  • Abnormal heart rhythm or other heart issues.
  • Major surgery recently or planned during the study.
  • Previously treated with certain immune therapies.
  • Unable to attend scheduled study visits.

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