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Saltikva for Pancreatic Cancer
Phase 2
Recruiting
Led By Gerald Batist, MD
Research Sponsored by Salspera LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status =< 1
Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X IULN if no liver metastasis or =< 5 X IULN if liver metastases are present
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial is testing Saltikva, an attenuated strain of Salmonella Typhimurium expressing IL-2, to see if it can prolong overall survival in patients with Stage IV metastatic pancreatic cancer who are receiving standard chemotherapy.
Who is the study for?
This trial is for adults over 18 with metastatic pancreatic cancer that can't be surgically removed. Participants need to have a certain level of physical fitness, life expectancy over 16 weeks, and meet specific blood test criteria. They must not be on other experimental drugs or immunosuppressants, have brain metastases, uncontrolled illnesses like heart failure or infections, or significant cardiovascular disease.Check my eligibility
What is being tested?
The trial tests Saltikva (a modified Salmonella bacteria expressing IL-2) combined with standard chemotherapy (FOLFIRINOX or Gemcitabine/Abraxane). The goal is to see if adding Saltikva improves survival and slows down the cancer compared to just the standard chemo treatments.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as fever and chills, digestive issues like nausea and diarrhea from chemotherapy, increased risk of infection due to lowered white blood cell counts, liver function changes, fatigue, and potential allergic responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active and can carry on all pre-disease activities without restriction.
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My liver function tests are within the required range.
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My pancreatic cancer cannot be removed with surgery and has spread.
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My kidney function is normal or only slightly above normal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival
Progression Free Survival
Secondary outcome measures
Biological response
Radiologic response
Trial Design
2Treatment groups
Experimental Treatment
Group I: Saltikva with Gemcitabine/AbraxaneExperimental Treatment2 Interventions
30 patients will be enrolled to receive standard of care Gemcitabine/Abraxane with oral Salmonella-IL2 (Dose: 10-9) every 3 weeks for 2 years
Group II: Saltikva with FOLFIRINOXExperimental Treatment2 Interventions
30 patients will be enrolled to receive standard of care FOLFIRINOX with oral Salmonella-IL2 (Dose 10-9) every 2 weeks for 2 years
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Who is running the clinical trial?
Salspera LLCLead Sponsor
Gerald Batist, MDPrincipal InvestigatorMcGill University
8 Previous Clinical Trials
434 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking immunosuppressive drugs for a condition like an autoimmune disease.I am on long-term antibiotics to prevent infections.You have enough infection-fighting white blood cells.You are expected to live for more than 16 weeks.I am fully active and can carry on all pre-disease activities without restriction.My liver function tests are within the required range.Your total bilirubin level should be within a certain range based on the normal levels at the hospital.Your white blood cell count is at least 3,000 per microliter.You have had allergic reactions to drugs that are similar to Saltikva.I have a noticeable buildup of fluid in my abdomen.If you have diabetes or are at risk for high blood sugar, you can still join the trial, but your blood sugar must be well controlled (Hba1c < 7.5).I do not have brain metastases.You must have a disease that can be measured or seen by the doctors.I do not have HIV, active Hepatitis B or C.My pancreatic cancer cannot be removed with surgery and has spread.My kidney function is normal or only slightly above normal.I do not have severe heart problems or recent heart attacks.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.You are currently taking any other experimental medications.Your platelet count is at least 100,000 per microliter.
Research Study Groups:
This trial has the following groups:- Group 1: Saltikva with FOLFIRINOX
- Group 2: Saltikva with Gemcitabine/Abraxane
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.
Are participants being enrolled for this trial at present?
"According to the clinicaltrials.gov listing, this trial is currently seeking volunteers, having been initially posted on October 20th 2020 and most recently updated on May 3rd 2022."
Answered by AI
How does Salmonella-IL2 affect the wellbeing of patients?
"Salmonella-IL2 has yet to be proven effective, so its safety score is 2; however, there are some preliminary data points supporting the drug's security."
Answered by AI
Are there any precedents of Salmonella-IL2 being tested in prior clinical trials?
"Currently, 1113 clinical trials are underway researching the efficacy of Salmonella-IL2. Of those active studies, 321 have reached Phase 3. Although these medical experiments largely occur in China's Shanghai region, there are 59447 other locations conducting research on this therapy."
Answered by AI
What medical conditions has Salmonella-IL2 been utilized to manage?
"Salmonella-IL2 is regularly administered to patients with metastatic neoplasm. In addition, this medication has been known to provide relief for those suffering from locally advanced non-small cell lung cancer, as well as urinary bladder and metastatic bladder cancers."
Answered by AI
What is the maximum number of participants for this investigation?
"Affirmative. Evidence posted on clinicaltrials.gov shows that this medical examination, which was inaugurated on October 20th 2020, is currently enrolling patients. Approximately sixty individuals need to be enrolled from a single research institute."
Answered by AI
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