Personalized chemotherapy for abdominal cancer treatment
Individualized Response Assessment to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for the Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Primaries
This study is testing a new way to personalize chemotherapy for patients with abdominal cancer by trying different treatments on their tumor samples before using them during surgery.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT04847063 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to enhance the effectiveness of heated intraperitoneal chemotherapy (HIPEC) following cytoreductive surgery (CRS) for patients with peritoneal carcinomatosis. By utilizing the SMART System, researchers will test various chemotherapy agents to determine their efficacy on tumor tissue samples before applying them in actual HIPEC treatments. The study will assess the correlation between ex vivo responses in the SMART System and in vivo outcomes, focusing on tumor necrosis and cell proliferation markers. Participants will undergo a series of screenings to ensure eligibility based on their cancer type and overall health.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed peritoneal carcinomatosis from specific cancer types who can safely undergo complete cytoreduction.
Not a fit: Patients with extra-abdominal metastatic disease or those unable to undergo complete cytoreduction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and personalized chemotherapy treatments for patients with peritoneal carcinomatosis.
How similar studies have performed: While HIPEC has been used in various studies, this specific approach utilizing the SMART System for personalized chemotherapy selection is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: * Confirmation of peritoneal carcinomatosis from peritoneal mesothelioma or atypical mesothelial proliferation, or from appendiceal, colorectal, or ovarian, histologies by the Laboratory of Pathology, NCI. * Measurable or evaluable disease as defined by RECIST v1.1. criteria and/or by peritoneal carcinomatosis index (PCI) score. * Participants must be assessed to be able to undergo optimal cytoreduction (i.e., completeness of cytoreduction score of 1 or 0) with laparoscopically assessed PCI score threshold as indicated below: * Primary Histology: Appendiceal/Colorectal/Ovarian / PCI Cutoff for Eligibility: Total Score \< 20 (out of 39 possible points) * Primary Histology: Mesothelioma or atypical mesothelial proliferation / PCI Cutoff for Eligibility: Total Score \<= 30 (out of 39 possible points) * Age \>= 18 years. * ECOG performance status \<= 1 (Karnofsky \>= 80%). * Participants must have adequate organ and marrow function as defined below: * Absolute neutrophil count \>= 1,000/mcL * Platelets \>= 75,000/mcL * Total bilirubin within \<=1.5x institutional upper limit of normal (ULN) * AST (SGOT)/ ALT (SGPT) \<= 3x institutional upper limit of normal (ULN), or \<= 5.0x ULN in participants with liver metastases (only) * Creatinine within normal institutional limits OR --Creatinine clearance \>= 60 mL/min/1.73 m\^2 for participants with creatinine levels above institutional normal calculated using eGFR. * Because therapeutic agents used in this trial are known to be teratogenic, individuals of child-bearing potential (IOCBP) and individuals who are able to father a child must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 180 days after last study treatment. * Ability of participant to understand and the willingness to sign a written informed consent document. * Ability and willingness of the participant to co-enroll on the tissue collection protocol 13C0176, Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors . EXCLUSION CRITERIA: * Participants with known extra-abdominal metastatic disease from the participant s appendiceal, colorectal, ovarian, or peritoneal mesothelioma primary. * Participants who have received intraperitoneal chemotherapy or other anti-cancer therapy within the last 4 weeks prior to the start of study treatment. * Participants who have undergone major surgery within the last 12 weeks prior to the start of study treatment. * History of allergic reactions attributed to platinum-containing compounds. * History of dihydropyrimidine dehydrogenase deficiency (only participants with appendiceal or colorectal cancer). * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant individuals are excluded from this study because the protocol involves major abdominal surgery and chemotherapeutic agents with the potential for teratogenic or abortifacient effects. Note: Due to an unknown but potential risk for adverse events in nursing infants secondary to treatment of the participant, nursing (including breastfeeding) should be discontinued if the participant is undergoing treatment (i.e., nursing participants must agree to discontinue nursing activities). * HIV-positive participants with detectable viral load despite antiretroviral therapy are ineligible because of participants increased risk of lethal infections when treated with marrow-suppressive therapy. HIV-positive participants who have undetectable viral load on antiretroviral therapy may be considered for this study only after consultation with a NIAID physician.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Andrew M Blakely, M.D. — National Cancer Institute (NCI)
- Study coordinator: Stephanie N Canady, R.N.
- Email: stephanie.canady@nih.gov
- Phone: (240) 858-7573
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.