Chemotherapy + Anakinra for Pancreatic Cancer

Overseen By Page Blas, MA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Baylor Research Institute

Must not be taking: Immunosuppressants, IL-1 inhibitors

Disqualifiers: Organ transplant, Stage IV cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment combination for pancreatic cancer by adding Anakinra, an anti-inflammatory medication, to standard chemotherapy. Researchers believe that addressing inflammation, a key factor in cancer growth, might enhance treatment effects. The trial tests this approach in patients with pancreatic cancer that may be surgically removed. Those with pancreatic ductal adenocarcinoma that might be treated surgically may find this study suitable. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on active immunosuppressive therapy or have had prior chemotherapy or radiation for pancreatic cancer.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that anakinra, when combined with standard chemotherapy, is generally safe for patients with pancreatic cancer. Research indicates that patients receiving anakinra with chemotherapy such as FOLFIRINOX experienced manageable side effects, suggesting the treatment is usually well-tolerated. Anakinra reduces inflammation, a significant factor in pancreatic cancer. Although all treatments carry some risks, early findings suggest that combining anakinra with chemotherapy does not lead to unexpected or severe side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pancreatic cancer?

Unlike the standard chemotherapy for pancreatic cancer, which typically involves drugs like Nab-paclitaxel, gemcitabine, and cisplatin, the new treatment approach adds Anakinra to the mix. Anakinra is unique because it targets inflammation by blocking interleukin-1, a protein that can promote cancer growth. By combining this with chemotherapy, researchers hope to enhance the overall effectiveness against the cancer cells and potentially improve patient outcomes. This dual approach could offer a new way to attack pancreatic cancer more aggressively and efficiently.

What evidence suggests that this trial's treatments could be effective for pancreatic cancer?

In this trial, participants will receive Anakinra alongside chemotherapy. Research has shown that Anakinra, when combined with chemotherapy, can slow the growth of pancreatic tumors. Anakinra blocks a protein called IL-1, which causes inflammation and significantly contributes to pancreatic cancer. Studies have found that Anakinra, with or without the chemotherapy drug gemcitabine, effectively slows tumor growth. Other research indicates that using Anakinra with standard chemotherapy treatments is safe for patients with pancreatic cancer. These findings suggest that adding Anakinra to chemotherapy might enhance treatment effectiveness for people with pancreatic cancer. ^{3 4 5 6 7}

Who Is on the Research Team?

A. Scott Paulson, MD

Principal Investigator

Charles A. Sammons Cancer Center/Texas Oncology

Are You a Good Fit for This Trial?

Adults with resectable or locally advanced pancreatic adenocarcinoma (stages I-III) can join. They must be in good health overall, with specific blood and organ function criteria met. Participants need to agree to use contraception during the study and for a month after, and they cannot have had prior treatments for their cancer.

Inclusion Criteria

Patients must be accessible for treatment and follow-up

My kidney function is within the normal range.

My pancreatic cancer can potentially be removed with surgery.

Exclusion Criteria

I have not had major surgery or any vascular device placement in the last 2 weeks.

I do not have any ongoing serious infections requiring treatment.

I am HIV positive.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Chemotherapy

Participants receive pre-operative chemotherapy with Nab-paclitaxel, gemcitabine, and cisplatin, along with Anakinra

8-12 weeks

Surgery

Participants undergo surgical resection of pancreatic adenocarcinoma

1 week

Post-operative Chemotherapy

Participants receive post-operative chemotherapy with 5-fluorouracil, oxaliplatin, and irinotecan, along with Anakinra

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Anakinra
• Perioperative Chemotherapy

Trial Overview The trial is testing Anakinra combined with chemotherapy in patients undergoing surgery for pancreatic cancer. It's based on how inflammation affects pancreas cancer and aims to see if blocking certain inflammatory signals can help improve treatment outcomes.

How Is the Trial Designed?

Group I: Anakinra plus Chemotherapy Experimental Treatment 1 Intervention

Patients will receive Anakinra during both pre-operative chemotherapy with Nab-paclitaxel, gemcitabine and cisplatin, followed by surgery and post-operative chemotherapy with 5-fluorouracil, oxaliplatin, and irinotecan.

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials

210

Recruited

205,000+

Published Research Related to This Trial

Neoadjuvant chemotherapy, given before surgery, is safe and effective for patients with resectable pancreatic cancer, potentially improving their nutritional status and leading to a median survival of 26.5 months, as shown in a recent phase II trial.

The NEOPAC phase III trial will compare the efficacy of neoadjuvant chemotherapy followed by surgery against surgery followed by adjuvant chemotherapy, with a primary focus on progression-free survival in 310 patients, aiming to provide valuable insights into treatment outcomes for pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant gemcitabine versus NEOadjuvant gemcitabine/oxaliplatin plus adjuvant gemcitabine in resectable pancreatic cancer: a randomized multicenter phase III study (NEOPAC study). Heinrich, S., Pestalozzi, B., Lesurtel, M., et al.[2022]

Chemotherapy regimens using gemcitabine or 5-FU have been shown to provide benefits for patients with advanced pancreatic carcinoma.

Adjuvant chemotherapy after complete surgical removal of the tumor may improve survival rates, as indicated by some studies, highlighting the potential for enhanced treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Chemotherapy of pancreatic carcinoma]. Lutz, MP.[2022]

Adding adjuvant chemotherapy to surgery for localized pancreatic adenocarcinoma may improve overall survival rates, as suggested by the ESPAC-1 trial, despite the chemotherapy regimens being considered less effective for advanced disease.

The role of radiotherapy in combination with chemotherapy remains unclear, but it is still being explored as part of a comprehensive treatment strategy for localized pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined-modality treatment for operable pancreatic adenocarcinoma. Pisters, PW., Wolff, RA., Crane, CH., et al.[2007]

The NEONAX trial is a large, phase II study involving 166 patients with resectable pancreatic ductal adenocarcinoma, comparing the efficacy of perioperative chemotherapy (nab-paclitaxel and gemcitabine) against standard adjuvant therapy to improve disease-free survival (DFS) at 18 months.

Preliminary evidence suggests that nab-paclitaxel/gemcitabine has a favorable toxicity profile compared to FOLFIRINOX, making it a promising option for patients undergoing surgery for pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neoadjuvant plus adjuvant or only adjuvant nab-paclitaxel plus gemcitabine for resectable pancreatic cancer - the NEONAX trial (AIO-PAK-0313), a prospective, randomized, controlled, phase II study of the AIO pancreatic cancer group. Ettrich, TJ., Berger, AW., Perkhofer, L., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6437768/

IL-1 Receptor Antagonist Inhibits Pancreatic Cancer ... We found that anakinra, an FDA-approved drug that inhibits IL-1 receptor (IL-1R), when given with or without gemcitabine, can reduce tumor growth by inhibiting ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11312284/

Anakinra-Loaded Sphingomyelin Nanosystems Modulate ... In pancreatic cancer, the use of a recombinant IL-1R antagonist (IL1RA, anakinra, ANK) in in vitro and in vivo models has shown efficacy in targeting the IL-1/ ...

3. diva-portal.org diva-portal.org/smash/get/diva2:1806294/FULLTEXT01.pdf

Therapeutic role of interleukin-1 receptor antagonist in ... In this study, we used data on acute (1,986 cases) and chronic (514 cases) pancreatitis and pancreatic cancer (589 cases) from genome-wide ...

4. npcf.us npcf.us/clinical-trials/a-pilot-prospective-non-randomized-evaluation-of-the-safety-of-anakinra-plus-standard-chemotherapy/

A Pilot, Prospective, Non-randomized Evaluation Of The ... The study's overall objectives are to evaluate the safety of anakinra in combination with standard chemotherapy regimens in patients with pancreatic ductal ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2016.34.15_suppl.e15750

A pilot, non-randomized evaluation of the safety ... Conclusions: Anakinra in combination with FOLFIRINOX in patients with metastatic pancreatic cancer is safe and feasible, with adverse events ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02021422

Study Details | NCT02021422 | A Pilot, Prospective, Non- ... The study's overall objectives are to evaluate the safety of anakinra in combination with standard chemotherapy regimens in patients with pancreatic ductal ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10538534/

Therapeutic role of interleukin-1 receptor antagonist in ... Results. Genetically predicted higher levels of IL-1RA were associated with a lower risk of acute and chronic pancreatitis and pancreatic cancer ...