Mesalamine for Colitis Prevention During Cancer Treatment

(IMPACT 1 Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AHS Cancer Control Alberta

Must not be taking: Immunosuppressants

Disqualifiers: Cardiovascular disease, Hypersensitivity, 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: 8

Duration: 12 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The study team's principal interest is to address the question, "Will prophylactic treatment with mesalamine reduce the incidence and severity of immune-related diarrhea occurring secondarily to treatment with ipi/nivo?"

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot use certain immunosuppressive medications. It's best to discuss your specific medications with the study team.

What data supports the effectiveness of the drug Mesalamine for colitis prevention during cancer treatment?

Mesalamine has been shown to be effective in maintaining remission in ulcerative colitis, a condition similar to colitis, by reducing inflammation in the colon. Additionally, mesalamine has been reported to protect against colorectal cancer related to inflammatory bowel disease, suggesting potential benefits in preventing colitis during cancer treatment. ^{1 2 3 4 5}

Is mesalamine safe for humans?

Mesalamine is generally considered safe for humans and is commonly used to treat ulcerative colitis, with studies comparing different formulations for safety and effectiveness. ^{1 4 6 7 8}

How is the drug mesalamine unique for preventing colitis during cancer treatment?

Mesalamine is unique because it is primarily used to treat ulcerative colitis and has shown potential in preventing colorectal cancer by reducing inflammation, which is a novel approach for colitis prevention during cancer treatment. ^{1 4 8 9 10}

Eligibility Criteria

Adults with advanced melanoma who can consent to treatment, are not pregnant or breastfeeding, agree to use effective birth control, and have no severe health issues that could interfere with the trial. They must have a certain level of blood cells and organ function.

Inclusion Criteria

My blood counts and kidney, liver functions are within required ranges.

My melanoma is at an advanced stage and cannot be surgically removed.

I am 18 years old or older.

Exclusion Criteria

I am not on immunosuppressive medication, except for allowed cases.

I have a serious heart condition.

I don't have any severe health issues that could make the study risky for me.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive prophylactic Mesalamine in combination with Ipilimumab/Nivolumab over 4 cycles

12 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 12, 18, and 24 weeks

24 weeks

3 visits (in-person)

Treatment Details

Interventions

• Mesalamine

Trial Overview The trial is testing if mesalamine can prevent or lessen diarrhea caused by ipi/nivo therapy in melanoma patients. It's seeing whether taking mesalamine before starting cancer treatment makes a difference.

Participant Groups

Group I: Prophylactic Mesalamine in combination of Immunotherapy (Nivolumab/Ipilimumab) Experimental Treatment 1 Intervention

Participants will receive 500mg of Mesalamine QID (four times a day) in combination with standard of care Immunotherapy

Who Is Running the Clinical Trial?

AHS Cancer Control Alberta

Lead Sponsor

Trials

188

Recruited

26,900+

References

1. United States pubmed.ncbi.nlm.nih.gov

Inhibition of colon carcinogenesis by 2-methoxy-5-amino-N-hydroxybenzamide, a novel derivative of mesalamine. [2016]

2. England pubmed.ncbi.nlm.nih.gov

Once daily oral mesalamine compared to conventional dosing for induction and maintenance of remission in ulcerative colitis: a systematic review and meta-analysis. [2018]

3. Australia pubmed.ncbi.nlm.nih.gov

Once-daily versus multiple-daily mesalamine for patients with ulcerative colitis: a meta-analysis. [2014]

4. England pubmed.ncbi.nlm.nih.gov

Direct comparison of two different mesalamine formulations for the induction of remission in patients with ulcerative colitis: a double-blind, randomized study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Extended-release mesalamine granules for ulcerative colitis. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of Long-Term Mesalamine Therapy on Cancer-Associated Gene Expression in Colonic Mucosa of Patients with Ulcerative Colitis. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Mesalamine inhibits epithelial beta-catenin activation in chronic ulcerative colitis. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Chemoprevention of colorectal neoplasia in ulcerative colitis: the effect of 6-mercaptopurine. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Progression to colorectal neoplasia in ulcerative colitis: effect of mesalamine. [2013]

10. England pubmed.ncbi.nlm.nih.gov

Direct comparison of two different mesalamine formulations for the maintenance of remission in patients with ulcerative colitis: a double-blind, randomized study. [2021]