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Ampligen for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: AIM ImmunoTech Inc.

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the safety and efficacy of Ampligen in patients with locally advanced pancreatic adenocarcinoma

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that you should not have received investigational drugs within 6 weeks before starting the study medication.

What data supports the effectiveness of the drug Rintatolimod (Ampligen) for pancreatic cancer?

Research shows that Rintatolimod (Ampligen) may help improve survival in pancreatic cancer patients by boosting the immune system. In a study, patients treated with Rintatolimod lived longer compared to those who did not receive the drug, with a median survival of 19 months versus 12.5 months.¹ ² ³ ⁴ ⁵

Is Ampligen (Rintatolimod) safe for use in humans?

Rintatolimod (Ampligen) has been used in patients with pancreatic cancer and was well-tolerated, meaning it did not cause significant harmful effects in the study participants.¹ ⁴ ⁵ ⁶ ⁷

How does the drug Ampligen differ from other treatments for pancreatic cancer?

Ampligen (rintatolimod) is unique because it works by boosting the immune system through the TLR-3 receptor, potentially improving survival in pancreatic cancer patients. Unlike standard chemotherapy, it enhances the body's immune response, particularly increasing B-cell numbers, which may contribute to longer survival.¹ ² ⁴ ⁵ ⁸

Research Team

David R Strayer, MD

Principal Investigator

AIM ImmunoTech Inc.

Eligibility Criteria

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.

Inclusion Criteria

I am mostly self-sufficient and active.

I weigh at least 40kg.

Provide signed written informed consent and willingness, ability to comply with study requirements

See 10 more

Exclusion Criteria

I have a history of or currently have hepatitis A, B, or C.

Pregnant or lactating women

I need fluid removed from my abdomen at least every 2 weeks.

See 15 more

Treatment Details

Interventions

Rintatolimod (Immunomodulator)

Trial OverviewThe 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.

Participant Groups

4Treatment groups

Experimental Treatment

Active Control

Group I: Ampligen / rintatolimod + SOC ChemoradiationExperimental Treatment1 Intervention

Subjects will receive rintatolimod \[intravenous (IV)\], up to 400 mg twice weekly plus SOC chemoradiation until disease progression

Group II: Ampligen / rintatolimod + SOCExperimental Treatment1 Intervention

Subjects will receive rintatolimod \[intravenous (IV)\], up to 400 mg twice weekly plus SOC (SOC does not include chemoradiation) until disease progression

Group III: SOC Chemoradiation AloneActive Control1 Intervention

Subjects will receive SOC chemoradiation until evidence of disease progression.

Group IV: SOC AloneActive Control1 Intervention

Subjects will receive SOC (SOC does not include chemoradiation) until evidence of disease progression.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:

Virginia Mason Medical CenterSeattle, WA

Gabrail Cancer Center ResearchCanton, OH

Nebraska Medical CenterOmaha, NE

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Who Is Running the Clinical Trial?

AIM ImmunoTech Inc.

Lead Sponsor

Trials

Patients Recruited

710+

Amarex Clinical Research

Collaborator

Trials

Patients Recruited

1,700+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long term survival on S-1 monotherapy in a patient with recurrent stage IV pancreatic cancer.Alsamarai, S., Zergebel, C., Zhang, J., et al.[2013]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunological combination treatment holds the key to improving survival in pancreatic cancer.Sodergren, MH., Mangal, N., Wasan, H., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II study of gemcitabine and erlotinib as adjuvant therapy for patients with resected pancreatic cancer.Bao, PQ., Ramanathan, RK., Krasinkas, A., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rintatolimod (Ampligen®) Enhances Numbers of Peripheral B Cells and Is Associated with Longer Survival in Patients with Locally Advanced and Metastasized Pancreatic Cancer Pre-Treated with FOLFIRINOX: A Single-Center Named Patient Program.El Haddaoui, H., Brood, R., Latifi, D., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rintatolimod: a potential treatment in patients with pancreatic cancer expressing Toll-like receptor 3.Haddaoui, HE., van Eijck, CW., Doukas, M., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase II trial of raltitrexed (Tomudex) in advanced pancreatic and biliary carcinoma.François, E., Hebbar, M., Bennouna, J., et al.[2014]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open-label, Phase I Study of Nivolumab Combined with nab-Paclitaxel Plus Gemcitabine in Advanced Pancreatic Cancer.Wainberg, ZA., Hochster, HS., Kim, EJ., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rintatolimod Induces Antiviral Activities in Human Pancreatic Cancer Cells: Opening for an Anti-COVID-19 Opportunity in Cancer Patients?Mustafa, DAM., Saida, L., Latifi, D., et al.[2021]