CLINICAL TRIAL

Anakinra for Adenocarcinoma

Metastatic
Stage I
Waitlist Available · 18+ · All Sexes · Dallas, TX

This study is evaluating whether anakinra can be used to reduce the side effects of chemotherapy for people with pancreatic cancer.

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About the trial for Adenocarcinoma

Eligible Conditions
Adenocarcinomas of the Pancreas · Adenocarcinoma

Treatment Groups

This trial involves 2 different treatments. Anakinra is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Anakinra
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anakinra
FDA approved

Side Effect Profile for Anakinra & Pentoxifylline & Zinc Sulfate

Anakinra & Pentoxifylline & Zinc Sulfate
Show all side effects
19%
Acute Kidney Injury
11%
Ascites
9%
Nausea
9%
Urinary tract infection
8%
Hematemesis
8%
Upper GI hemorrhage
8%
Clostridium difficile infection
6%
Hepatic failure
6%
C. difficile infection
6%
Encephalopathy
4%
Peritonitis
4%
Esophageal varices hemorrhage
4%
Tachycardia
4%
Multiple Organ Dysfunction Syndrome (MODS)
4%
Respiratory Failure
2%
Viremia
2%
Baceteremia
0%
Nocardia sepsis
0%
Candida infection
0%
Histoplasmosis infection
0%
Aspergillus infection
0%
Pneumonia
0%
Hypoxia
0%
Acute Respiratory Distress Syndrome
0%
Lung infection
0%
Cardiac failure
Acute Kidney Injury
19%
Ascites
11%
Nausea
9%
Urinary tract infection
9%
Hematemesis
8%
Upper GI hemorrhage
8%
Clostridium difficile infection
8%
Hepatic failure
6%
C. difficile infection
6%
Encephalopathy
6%
Peritonitis
4%
Esophageal varices hemorrhage
4%
Tachycardia
4%
Multiple Organ Dysfunction Syndrome (MODS)
4%
Respiratory Failure
4%
Viremia
2%
Baceteremia
2%
Nocardia sepsis
0%
Candida infection
0%
Histoplasmosis infection
0%
Aspergillus infection
0%
Pneumonia
0%
Hypoxia
0%
Acute Respiratory Distress Syndrome
0%
Lung infection
0%
Cardiac failure
0%
This histogram enumerates side effects from a completed 2018 Phase 2 & 3 trial (NCT01809132) in the Anakinra & Pentoxifylline & Zinc Sulfate ARM group. Side effects include: Acute Kidney Injury with 19%, Ascites with 11%, Nausea with 9%, Urinary tract infection with 9%, Hematemesis with 8%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
is a histologically heterogeneous tumor that is staged clinically based on the presence or absence of distant metastases show original
The patient has a performance status of 0 to 1 according to the Eastern Cooperative Oncology Group. show original
The patient's serum total bilirubin level must be ≤2 x the upper limit of normal (ULN) mg/dL, prior to initiation of treatment. show original
The American Joint Committee on Cancer has designated pancreatic carcinoma as occurring in stages I-III. show original
You must be 18 years of age or older to purchase this product. show original
The cancer is in the pancreas and is made up of cells that look like ductal adenocarcinoma. show original
Absolute neutrophil count (ANC) ≥1500/mm3;
Neutrophils ≥ 7,000 x 10^3/µl Platelets are at a normal level show original
Hemoglobin must be 9g/dL or higher (without the need for a red blood transfusion). show original
The serum albumin level is ≥2.0 g/dL. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 24 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 24 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Anakinra will improve 1 primary outcome and 7 secondary outcomes in patients with Adenocarcinoma. Measurement will happen over the course of 12 months.

To determine the effect of anakinra in combination with perioperative chemotherapy on the median disease free survival (DFS). A benchmark of 12 months DFS will be used to determine how many patients meet or exceed this goal.
12 MONTHS
12 MONTHS
To determine the effect of anakinra in combination with perioperative chemotherapy on the inflammasomes ( IL6, CRP, IL1α and IL1β) in blood and in the resected pathology specimens.
24 MONTHS
24 MONTHS
To determine the R0 resection rates (complete tumor removal with negative resection margins) obtained with anakinra + pre-operative chemotherapy.
24 MONTHS
24 MONTHS
To determine the effect of anakinra in combination with perioperative chemotherapy on patients' health-related quality of life by monitoring patients using EORTC quality of life survey questionnaire (EORTC QLQ-C30).
24 MONTHS
24 MONTHS
To determine the percentage of patients that have a normalization of CA19-9 after pre-op treatment with the combination of nab-paclitaxel (abraxane), gemcitabine, cisplatin and anakinra.
24 MONTHS
24 MONTHS
To determine the effect of anakinra in combination with perioperative chemotherapy on response rate
24 MONTHS
24 MONTHS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the average age someone gets adenocarcinoma?

Adenocarcinoma occurs most often at an older age than other cancers, especially lung cancer and colon cancer. It is important for patients diagnosed with adenocarcinoma to be aware of this fact. Patients should be aware of cancer screening options to prevent cancer deaths before they occur. It is crucial to understand what can be done to prevent adenocarcinoma and how early detection can reduce the death rate due to cancer.

Anonymous Patient Answer

What are the signs of adenocarcinoma?

Adenocarcinomas generally have characteristic features based on their histopathology. Adenocarcinomas are commonly associated with gastrointestinal symptoms such as weight loss, anemia, painful diarrhea, constipation, and abdominal pain. Other signs may include fever, jaundice, night sweats, and elevated CEA levels. Although adenocarcinomas are usually much larger than other cancers, they can be detected using CT scan. A biopsy of the tumor tissue may reveal cells that shed microscopic fragments into the bloodstream. These fragments can lead to lumps in the chest X-ray. The fragments can form a'soap bubble' appearance if not captured within the lung.

Anonymous Patient Answer

How many people get adenocarcinoma a year in the United States?

If we want to know how many people get this cancer annually, we need to take into account both the incidence rates of the disease and its survival rates. The survival rate is particularly important. Only about 1 in 3 people who die of cancer in the United States dies of cancer that has spread. However, if we look at the incidence rates, they are very different: one in 5 Americans is expected to develop cancer before dying and one in 88 Americans is expected to die of cancer. Half of those deaths will occur within 15 years of diagnosis. The incidence rate of adenocarcinoma is much higher than the overall incidence rate for cancers combined.

Anonymous Patient Answer

How quickly does adenocarcinoma spread?

Most adenocarcinomas spread slowly; only 3% of cancers in the colon move as far as the liver. Adenocarcinoma in the U.K. has a 5-year survival rate of about 60%, whereas colorectal cancer in the United States has an 18-year survival rate of 77%. [If these figures apply to the whole population, then there would be about 2,200 deaths per day in the UK and 17,000 deaths per day in the USA.

Anonymous Patient Answer

What does anakinra usually treat?

Anakinra is not effective in treating most cases of rheumatoid arthritis, but it is useful in treating some types of systemic lupus erythematosus. It is used off-label for many conditions beyond these rheumatic diseases.\n\nThe National Institutes of Health (NIH) states:\n"Anakinra may be prescribed for refractory cases of polyarteritis nodosa (PAN) who have failed immunosuppressive medication."\n\nIn 2010, the NIH stated:\n"This drug is indicated for the treatment of adults with relapsing polychondritis, which is a rare disease characterized by inflammation of cartilage and bone.

Anonymous Patient Answer

What causes adenocarcinoma?

Adenocarcinomas are cancers that start in epithelial tissue like the organs lining the digestive tract, inside the mouth (gums), nose and intestines. [Cancer.gov]\n\n- Lymphoepithelioma - Cancer.

Anonymous Patient Answer

Can adenocarcinoma be cured?

Adenocarcinoma may be cured if the tumor appears to have been completely removed at the time of surgery. The recurrence rate depends on the type of surgical resection and the site of recurrence after surgery. Recurrence rates are lower than those reported for squamous cell carcinoma, although they are higher than those reported in other studies.

Anonymous Patient Answer

How does anakinra work?

Anakinra had no effect on tumor growth in our mouse models of prostatic adenocarcinoma. In spite of this, we have shown an increase in plasma IL-1beta levels during treatment with anakinra. Based on these data, further investigation into the interaction between IL-1 receptor antagonists and cytokines is warranted.

Anonymous Patient Answer

What is the survival rate for adenocarcinoma?

Adenocarcinoma has the lowest overall survival rate compared to other histological types. In addition, mortality is higher for patients with Stage I disease than Stage III disease. Although there was no association between tumor size and survival, patients with T2N0 tumors have worse prognosis than T1N0 patients. The 5 year survival rates In a recent study were similar to recent reports, but different from previous studies. Further studies are needed to determine whether these results are variation in treatment protocols or differences in the pathogeneses of different histological types of ACCs.

Anonymous Patient Answer

Have there been other clinical trials involving anakinra?

Anakinra appears to be effective in treating patients with systemic lupus erythematosus. Data from a recent study suggest that this agent may also have some therapeutic effect in treating SLE-related pulmonary disease. However, prospective studies are needed.

Anonymous Patient Answer

Is anakinra typically used in combination with any other treatments?

Anakinra was rarely given alone in this cohort of cancer patients, but was commonly added to other chemotherapy regimens. Future research should focus on the role of cytokines in combating cancer cachexia and examine the use of cytokine inhibitors in combination with chemotherapy.

Anonymous Patient Answer
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