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New treatment option for Cancer
Official title Lactulose to Improve Gut Health in Cancer Patients Receiving Immunotherapy
ClinicalTrials.gov ID: NCT07354100
What this study is testing
What is Lactulose?
Lactulose is an investigational medicine, given as an once-daily, being studied as a potential treatment for cancer.
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
- The purpose of this study is to see if lactulose can improve the effectiveness of immunotherapy in patients with advanced cancer.
- Phase 2: a mid-size study of how well it works
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
- Phase I
- Patients must have a histologically confirmed malignancy that is to receive exclusively ICIs (no chemotherapy or RT in combination) per standard of...
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of lactulose in combination with ICIs in patients \<18...
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
- Patients must be able to ingest liquids.
You likely can't join if
- Exclusion Criteria for Phase I
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ICIs or lactulose.
- Current serious concomitant illnesses include cardiovascular diseases (such as uncontrolled congestive heart failure, hypertension, cardiac ischemia...
- The ongoing use of systemic antibiotics or the previous use of antibiotics in the 2 weeks before enrollment.
- Presence of a chronic intestinal disease (for example, celiac, or malabsorption) where the frequency of bowel movements would interfere with study...
- Absence of the large bowel.
See the full eligibility criteria
Who can join
- Phase I
- Patients must have a histologically confirmed malignancy that is to receive exclusively ICIs (no chemotherapy or RT in combination) per standard of care during the time in which lactulose will be administered. This...
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of lactulose in combination with ICIs in patients \<18 years of age, children are excluded from this study.
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
- Patients must be able to ingest liquids.
- Phase II
- Patients must have a histologically confirmed cutaneous or mucosal melanoma. Uveal melanoma is excluded.
- Measurable disease per RECIST 1.1.32
- Documented primary or acquired resistance to anti-PD-1 and anti-CTLA4 therapy per SITC guidelines.21 Primary resistance is defined as disease progression after a minimum of 6 weeks of therapy, provided the patient has...
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- Planned to receive standard ICI therapy (no RT/ICI or chemotherapy/ICI combinations).
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of lactulose in combination with ICIs in patients \<18 years of age, children are excluded from this study.
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
- Patients must be able to ingest liquids.
What rules you out
- Exclusion Criteria for Phase I
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ICIs or lactulose.
- Current serious concomitant illnesses include cardiovascular diseases (such as uncontrolled congestive heart failure, hypertension, cardiac ischemia, myocardial infarction, and severe cardiac arrhythmias), bleeding...
- The ongoing use of systemic antibiotics or the previous use of antibiotics in the 2 weeks before enrollment.
- Presence of a chronic intestinal disease (for example, celiac, or malabsorption) where the frequency of bowel movements would interfere with study assessments.
- Absence of the large bowel.
- The presence of absolute contraindications to lactulose administration includes galactosemia or other conditions that necessitate a low intake of galactose.
- Expected to require any other form of systemic anti-neoplastic therapy while in the study (i.e., chemotherapy or radiation therapy).
- Symptomatic CNS metastases and/or leptomeningeal involvement. Patients with CNS metastases and/or leptomeningeal involvement may participate if they are clinically stable, as judged by the enrolling investigator.
- Has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. Patients with vitiligo, type I diabetes, or resolved childhood...
- A history of immune-related adverse events to ICIs that precludes the investigator from comfortably re-challenging with ICIs.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Exclusion Criteria for Phase II
- Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥...
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ICIs or lactulose.
- Current serious concomitant illnesses include cardiovascular diseases (such as uncontrolled congestive heart failure, hypertension, cardiac ischemia, myocardial infarction, and severe cardiac arrhythmias), bleeding...
- The ongoing use of systemic antibiotics or the previous use of antibiotics in the 2 weeks before enrollment.
- Presence of a chronic intestinal disease (for example, celiac, or malabsorption) where the frequency of bowel movements would interfere with study assessments.
- Absence of the large bowel
- The presence of absolute contraindications to lactulose administration includes galactosemia or other conditions that necessitate a low intake of galactose.
- Expected to require any other form of systemic anti-neoplastic therapy while in the study (i.e., chemotherapy or radiation therapy).
- Symptomatic CNS metastases and/or leptomeningeal involvement. Patients with CNS metastases and/or leptomeningeal involvement may participate if they are clinically stable, as judged by the enrolling investigator.
- Has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. Patients with vitiligo, type I diabetes, or resolved childhood...
- A history of immune-related adverse events to ICIs that precludes the investigator from comfortably re-challenging with ICIs.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, 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 Chicago, Illinois, 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.