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New treatment option for T Cells
Official title A Phase IIa Randomized, Double-Blinded Clinical Trial of Naproxen or Aspirin for Cancer Immune Interception in Lynch Syndrome
ClinicalTrials.gov ID: NCT05411718
What this study is testing
What is Naproxen?
Naproxen is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for t cells.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To learn about the effects of naproxen and aspirin on the normal colon in people with Lynch Syndrome.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have Lynch syndrome defined as meeting any of the following:
- "Mutation-Positive Lynch syndrome": carriers or obligate carriers (by pedigree) of a pathogenic mutation in one of the DNA mismatch repair (MMR)...
- "Mutation-Negative Lynch syndrome": patients with a personal history of a non-sporadic MMR deficient premalignant lesion (i.e., polyp) or a...
- Participants must not have evidence of active/recurrent malignant disease for 6 months.
- Participants must be at least 6 months from any prior cancer-directed treatment (such as surgical resection, chemotherapy, immunotherapy, hormonal...
You likely can't join if
- Individuals with presence of two somatic mutations/loss of heterozygosity (LOH) in one of the four MMR genes (MLH1, MSH2, MSH6, and PMS2) in...
- Individuals who received scheduled NSAIDs or COX-inhibitors of any kind for \>3 days during anytime within the 2 weeks prior to baseline eligibility...
- Individuals who are status post total proctocolectomy (i.e., removal of all colon and rectum).
- Individuals with active gastroduodenal ulcer disease in the preceding 5 years.
- Individuals with any history of transfusion-dependent gastrointestinal bleeding, gastrointestinal perforation or gastrointestinal obstruction. If any...
- Individuals with history of myocardial infarction, stroke, coronary-artery bypass draft, invasive coronary revascularization in the preceding 5 years.
See the full eligibility criteria
Who can join
- Participants must have Lynch syndrome defined as meeting any of the following:
- "Mutation-Positive Lynch syndrome": carriers or obligate carriers (by pedigree) of a pathogenic mutation in one of the DNA mismatch repair (MMR) genes (i.e., MLH1, MSH2/EPCAM, MSH6, or PMS2).
- "Mutation-Negative Lynch syndrome": patients with a personal history of a non-sporadic MMR deficient premalignant lesion (i.e., polyp) or a non-sporadic MMR deficient malignant tumor (where "non-sporadic MMR deficient"...
- Participants must not have evidence of active/recurrent malignant disease for 6 months.
- Participants must be at least 6 months from any prior cancer-directed treatment (such as surgical resection, chemotherapy, immunotherapy, hormonal therapy or radiation).
- Participants must have endoscopically accessible distal colon and/or rectal mucosa (i.e., partici-pants must have at least part of the descending/sigmoid colon and/or rectum intact).
- Participants must consent to one standard of care lower GI endoscopy (flexible sigmoidoscopy or colonoscopy) with biopsies and one flexible sigmoidoscopy with biopsies that will be 12 months (+14 days) apart.
- Participants must consent to refrain from using aspirin or NSAIDs or COX-inhibitors for the du-ration of the trial
- Age ≥18 years. Because no dosing or adverse event data are currently available on the long-term use of naproxen or aspirin in patients \<18 years of age, children are excluded from this study but will be eligible for...
- ECOG performance status ≤1 OR Karnofsky ≥70%; see Appendix A.
- Participants must have normal organ and marrow function as defined below: Hemoglobin \>10 g/dL or Hematocrit \> 30 % Leukocyte count ≥3,000/microliter Platelet count ≥100,000/microliter Absolute neutrophil count...
- The effects of naproxen on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because NSAIDs are known to be teratogenic, women of child-bearing potential must agree to use...
- Ability to understand and the willingness to sign a written informed consent document.
- Willing and able to adhere to the prohibitions and restrictions specified in the final approved pro-tocol.
- Willing to undergo yearly standard of care screening colonoscopy for the duration of the clinical trial.
What rules you out
- Individuals with presence of two somatic mutations/loss of heterozygosity (LOH) in one of the four MMR genes (MLH1, MSH2, MSH6, and PMS2) in MMR-deficient neoplasm (defined as a tumor with MSI-H by PCR analysis or loss...
- Individuals who received scheduled NSAIDs or COX-inhibitors of any kind for \>3 days during anytime within the 2 weeks prior to baseline eligibility screening visit. By exception, individuals receiving cardio-protective...
- Individuals who are status post total proctocolectomy (i.e., removal of all colon and rectum).
- Individuals with active gastroduodenal ulcer disease in the preceding 5 years.
- Individuals with any history of transfusion-dependent gastrointestinal bleeding, gastrointestinal perforation or gastrointestinal obstruction. If any of these events had been due to a malignancy of the GI tract and the...
- Individuals with history of myocardial infarction, stroke, coronary-artery bypass draft, invasive coronary revascularization in the preceding 5 years.
- Individuals taking the drugs listed below may not be assigned by chance unless they are willing to stop the medications (and possibly change to alternative non-excluded medications to treat the same conditions) no less...
- Investigational agents;
- NSAIDs: such as ketorolac, sulindac, ibuprofen, and others;
- COX-2 inhibitors: such as Celecoxib, Rofecoxib and other COX-2;
- Antiplatelet agents: such as aspirin, clopidogrel, ticlopidine, dipyridamole, abciximab, tirofi-ban, eptifibatide and prasugrel;
- Anticoagulants:
- Heparin;
- Heparinoids: such as fondaparinux, danaparoid and other heparinoids;
- Low-molecular weight heparins: such as enoxaparin, dalteparin, parnaparin, reviparin, tinzaparin, ardeparin, certoparin, lepidurin, bivalidurin;
- Other anticoagulants: argatroban, apixaban, dabigatran, rivaroxaban, warfarin, aceno-coumarol, dicumarol, phenindione and other anticoagulants;
- Lithium;
- Selective serotonin and norepinephrine reuptake inhibitors: minalcipran, fluoxetine, paroxe-tine, nefazadine, citalopram, clovoxamine, escitalopram, flesinoxan, femoxitene, duloxetine, venlafaxine, vilazodone...
- Anticonvulsants: phenytoin, parakdehyde, valproic acid, carbamazepine, trimethadione, phenobarbital, diazepam, chlormethiazole, mephenytoin, ethotoin, paramethadione, phenac-emide, mephobarbital, oxcarbazepine...
- Antibiotics and antifungals: o Fluorquinolones: such as ofloxacin, norfloxacin, levofloxacin;
- Other agents: teriflunomide, cyclosporine, tacrolimus, ginkgo, gossypol, meadowsweet, fe-verfew, beta glucan, pentosan, pentoxifylline, cilostazol, erlotinib, pemetrexed, methotrex-ate, pralatrexate.
- Individuals with uncontrolled renal insufficiency or renal failure.
- History of allergic reactions attributed to naproxen or aspirin.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncon-trolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac ar-rhythmia, or...
- Pregnant, breast-feeding, or women of childbearing potential unwilling to use a reliable contra-ceptive method. Pregnant women are excluded from this study because Naproxen/NSAIDs is an agent with the potential for...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.