MicroOrganoSphere Drug Screen Pilot Trial in Colorectal Cancer (CRC)
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 22-007698
- Jacksonville, Florida: 22-007698
- Scottsdale/Phoenix, Arizona: 22-007698
NCT ID: NCT05189171
Sponsor Protocol Number: 146057.60
About this study
The primary objective of this study is to determine the feasibility of generating sufficient MicroOrganpSphere (MOS) from a biopsy of a patient's colorectal cancer liver metastasis to determine sensitivity to standard of care drug used in the treatment of colorectal cancer (oxaliplatin, irinotecan, 5-FU/Xeloda, Bevacizumab, Panitumumab or Cetuximab, Lonsurf, Regorafenib and Pembrolizumab or Nivolumab) in < 14 days.
The secondary objective of this study is to assess the association between standard of care drug sensitivity in MOS to clinical outcome of patient treated with standard of care therapy from which the MOS was derived.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
Subjects may participate in this study if all of the following criteria apply:
- Provide written informed consent.
- Male or female ages 18 or older.
- Evidence of cancer of the colon or rectum that is metastatic to the liver.
- NOTE: patients may enroll prior to receiving clinical biopsy results. If they are not confirmed to have adenocarcinoma of the colon or rectum that is metastatic to the liver, they will not be evaluable.
- Treating physician planning to treat CRC liver metastasis with a standard of care therapy.
- Previous adjuvant or neoadjuvant therapies allowed.
- Biopsy may be obtained prior to starting the 2nd cycle of a new standard of care therapy.
- Measurable disease as measured by RECIST 1.1 criteria.
- Life expectancy of ≥ 12 weeks.
- ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2.
- Adequate coagulation function as evidenced by:
- Absolute neutrophil count ≥ 1.0 x 10^9/L;
- Platelets ≥ 50 x 10^9/L;
- Hemoglobin ≥ 8 g/dL (transfusions are permitted to achieve baseline hemoglobin level);
- ALT/AST (alanine aminotransferase (ALT) / aspartate aminotransferase (AST)) < 2.5 x upper limit of normal (ULN); or
- < 5 x ULN in the presence of liver metastases;
- Total bilirubin < 1.5 x ULN (if total bilirubin ≥ 1.5 x ULN then the subject may participate if the direct bilirubin is ≤ 1.5 x ULN);
- Creatinine clearance > 30 mL/min measured or calculated by Cockcroft-Gault equation or the estimated glomerular filtration rate (GFR) > 30 mL/min/1.73 m^2 using the MDRD;
- INR < 1.5.
Exclusion Criteria:
Subjects may not participate if any of the following criteria apply:
- Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment.
- Clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from day 1 of start of therapy, New York Heart Association Class II, III or IV congestive heart failure, and arrhythmia requiring therapy.
- Presence of significant concurrent, uncontrolled medical condition including but not limited to renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, active infection, non-healing wound, or psychiatric disease that excludes them from receiving chemotherapy.
- Pregnant or actively breastfeeding women (Pregnant or breastfeeding women are not candidates for chemotherapy).
Eligibility last updated 7/20/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Hao Xie, M.D., Ph.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
Jacksonville, Fla.
Mayo Clinic principal investigator Jeremy Jones, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Christina Wu, M.B., B.Ch., M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available