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Immunomodulator
Immunotherapy + Chemotherapy for Stomach Cancer
Phase 1
Recruiting
Led By Travis E. Grotz, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of study entry to date of death or last follow up, assessed up to 3 years
Awards & highlights
Study Summary
This trial tests combining aldesleukin (immune-stimulator) and nivolumab (immunotherapy) w/ chemotherapy to treat gastric cancer spread to abdomen.
Who is the study for?
Adults with confirmed gastric or gastroesophageal junction adenocarcinoma that has spread to the abdominal lining, who are in relatively good health (ECOG 0-2) and have not shown non-peritoneal metastasis. They must be able to provide blood and tissue samples, return for follow-up, and meet specific blood count and organ function criteria. Pregnant or nursing individuals, those unwilling to use contraception, or those with certain prior treatments or severe concurrent diseases cannot participate.Check my eligibility
What is being tested?
The trial is testing aldesleukin combined with nivolumab (an immune system booster) alongside standard chemotherapy drugs fluorouracil, leucovorin calcium, and oxaliplatin. The goal is to see if this combination is more effective for patients whose stomach cancer has spread to the peritoneum compared to standard treatment alone.See study design
What are the potential side effects?
Possible side effects include typical chemotherapy reactions like nausea, fatigue, hair loss; immune-related issues such as rash or thyroid problems from nivolumab; and flu-like symptoms from aldesleukin such as fever and chills.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of study entry to date of death or last follow up, assessed up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of study entry to date of death or last follow up, assessed up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change of reduction in the peritoneal carcinomatosis index
Incidence of adverse events
Secondary outcome measures
Histological response of the peritoneal metastasis
Overall survival
Progression free survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (aldesleukin, nivolumab, chemotherapy)Experimental Treatment11 Interventions
Patients receive aldesleukin IP on study. Patients also receive standard of care nivolumab IV, leucovorin calcium IV, fluorouracil IV, and oxaliplatin IV on study. Patients also undergo diagnostic laparoscopy with biopsy, PET/CT or PET/MRI, and collection of blood and tissue samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorouracil
2014
Completed Phase 3
~11540
Nivolumab
2014
Completed Phase 3
~4750
Leucovorin Calcium
2011
Completed Phase 3
~12310
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Aldesleukin
2012
Completed Phase 4
~1620
Biospecimen Collection
2004
Completed Phase 2
~1700
Oxaliplatin
2011
Completed Phase 4
~2560
Positron Emission Tomography
2008
Completed Phase 2
~2240
Computed Tomography
2017
Completed Phase 2
~2720
Biopsy
2014
Completed Phase 4
~1090
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,216 Previous Clinical Trials
3,767,473 Total Patients Enrolled
Travis E. Grotz, M.D.Principal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
40 Total Patients Enrolled
Travis E GrotzPrincipal InvestigatorMayo Clinic in Rochester
2 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a heart attack in the last 6 months and don't need ongoing therapy for severe heart rhythm problems.My cancer has spread beyond the peritoneum, found during a laparoscopy.I am not willing to use birth control during the study.I have not had a blockage in my small intestine in the last 15 days.I am currently being treated for another cancer within the last 6 months.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.My cancer is confirmed as stomach or GEJ adenocarcinoma.I have previously been treated with IL-2, chronic corticosteroids, or immunosuppressive drugs.I have previously used immune therapies or been on long-term steroids or immunosuppressants.I had a heart attack less than 6 months ago or have severe heart failure.I am 18 years old or older.My cancer has not spread beyond the peritoneal cavity.I can take care of myself and am up and about more than half of my waking hours.My Peritoneal Carcinomatosis Index score is between 1 and 24, measured within the last 30 days.My blood clotting tests are normal or managed if I'm on blood thinners.My cancer has spread to the lining of my abdomen.I am immunocompromised or HIV positive and on antiretroviral therapy.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I am currently undergoing treatment for cancer.I am currently on or about to start FOLFOX and nivolumab treatment without my cancer getting worse.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (aldesleukin, nivolumab, chemotherapy)
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 there any openings remaining for participants in this research initiative?
"According to clinicaltrials.gov, the current recruitment status of this study is closed and no longer accepting patients. The trial was initially posted on May 5th 2023 before being most recently updated on April 5th 2023. However, there are still 3541 other trials actively recruiting candidates at present."
Answered by AI
Has the FDA granted authorization for aldesleukin, nivolumab, and chemotherapy as treatment options?
"Our team has classified the safety of this treatment (aldesleukin, nivolumab, chemotherapy) as a 1 due to its Phase 1 status; implying only preliminary data exists that supports both efficacy and safety."
Answered by AI
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