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New treatment option for Clinical Stage 0 Cutaneous Melanoma AJCC v8
Official title Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer
ClinicalTrials.gov ID: NCT03819296
What this study is testing
What is Infliximab?
Infliximab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for clinical stage 0 cutaneous melanoma ajcc v8.
Also referred to as Avakine, cA2.
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
- This trial studies the role of the gut microbiome and effectiveness of a fecal transplant on medication-induced gastrointestinal (GI) complications in patients with melanoma or genitourinary cancer. The gut microbiome (the bacteria and microorganisms that live in the digestive system) may affect whether or not someone develops colitis (inflammation of the intestines) during cancer treatment with immune-checkpoint inhibitor drugs.
- Phase 1: an early, usually small safety study
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
- Diagnosis of any stage melanoma, Non-Small Cell Lung Cancer or genitourinary (GU) malignancies (Project 1).
- Diagnosis of any cancer type (Projects 2 and 3)
- Treatment with any ICPI agent
- Ability to understand and willingness to sign an informed consent form and rate surveys
- Life expectancy \> 4 months (Project 3)
You likely can't join if
- Age younger than 18 years
- History of inflammatory bowel disease, and/or radiation enteritis or colitis with active disease status at the time of study treatment initiation
- Pregnant and breastfeeding women
- Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was \> 1...
- Patients who develop concurrent non- GI toxicity at the time of FMT treatment (project 3)
- Patients with active bacterial or fungal infection (Project 3)
See the full eligibility criteria
- Diagnosis of any stage melanoma, Non-Small Cell Lung Cancer or genitourinary (GU) malignancies (Project 1).
- Diagnosis of any cancer type (Projects 2 and 3)
- Treatment with any ICPI agent
- Ability to understand and willingness to sign an informed consent form and rate surveys
- Life expectancy \> 4 months (Project 3)
- ICPI-related diarrhea and/or colitis of any grade with or without concurrent non- GI toxicity as the toxicity group (project 1)
- Patients with no organ toxicity as the control group (project 1)
- ICPI-related colitis and/or diarrhea of grade ≥ 2 as GI toxicity (initial episode or recurrence) receiving standard treatment of immunosuppressive agents (steroid, infliximab, vedolizumab, or ustekinumab) any time...
- ICPI-related colitis and/or diarrhea of grade ≥ 2 as GI toxicity without involvement of non- GI toxicity within 45 days prior to FMT (Project 3)
- ICPI-related colitis and/or diarrhea of grade ≥ 2 within 45 days prior to FMT with ANY of the following characteristics (project 3): (i) refractory to treatment of steroid and two doses of non-steroidal...
- No concern for active concomitant GI infection for the ICPI diarrhea/colitis work up at the time of protocol therapy initiation as confirmed by stool tests or as per the treating physician based on clinical presentation...
- Patient who has been cleared for enrollment by Infectious Diseases consultant or treating physician if positive infection workup or screening tests (e.g. lifelong positive T-spot due to BCG inoculation, chronic...
- Age younger than 18 years
- History of inflammatory bowel disease, and/or radiation enteritis or colitis with active disease status at the time of study treatment initiation
- Pregnant and breastfeeding women
- Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was \> 1 year prior to consent and/ or clear documentation states that patient...
- Patients who develop concurrent non- GI toxicity at the time of FMT treatment (project 3)
- Patients with active bacterial or fungal infection (Project 3)
- Donors at risk for monkeypox infection and/ or exposure as determined by a questionnaire (Project 3) Withdrawal Criteria
- Patients may withdraw from the trial at any time
- Patients who develop GI perforation or toxic colitis that require surgery from ICPI colitis
- In project 3, if the first 30% of cases fail the fecal transplant treatment, then project 3 will be terminated
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.