Colon Cancer Clinical Trial

MicroOrganoSphere Drug Screen Pilot Trial in Colorectal Cancer (CRC)

Summary

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.

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Full Description

The purpose of this study is to assess the feasibility of creating patient derived models of cancer (i.e., MOS) from patients with colorectal cancer liver metastasis. The investigators of this study focus on a precision medicine strategy for patients with CRC liver metastasis.

Participating subjects will undergo biopsy of patient's liver lesion and the diagnosis of CRC liver metastasis will be verified by pathology. Patients will be treated with standard of care therapy determined by the treating physician. As part of standard of care therapy, patients will undergo lab work including CEA (carcinoembryonic antigen) and CT of the chest, abdomen and pelvis for staging and measurement of tumor size every two months.

Up to 250 patients will be enrolled to the study. Enrolled subjects are defined as subjects who give informed consent. Screen failures are defined as subjects who give informed consent and do not meet eligibility criteria. Accrued subjects are defined as subjects who give informed consent and meet eligibility criteria. Evaluable subjects are defined as those who accrue, receive the study biopsy and have cytologically or histologically confirmed adenocarcinoma of the colon or rectum that is metastatic to the liver. If the biopsy tissue is not confirmed to be adenocarcinoma of the colon or rectum, the subject will be considered non-evaluable and will be replaced.

MOS will be generated from the study biopsy and a drug screen will be performed to determine sensitivity to standard of care therapy. This method has been proven to have a 75% success rate of generating MOS and testing sensitivity to standard of care therapy from tumor biopsy samples.

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Eligibility Criteria

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. 10 Adequate coagulation function as evidenced by:

Absolute neutrophil count ≥ 1.0 x 109/L
Platelets ≥ 50 x 109/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 m2 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).

Study is for people with:

Colon Cancer

Estimated Enrollment:

180

Study ID:

NCT05189171

Recruitment Status:

Recruiting

Sponsor:

Xilis, Inc.

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There are 9 Locations for this study

See Locations Near You

Mayo Clinic
Scottsdale Arizona, 85259, United States More Info
Christina S Wu, MD
Principal Investigator
MedStar Washington Hospital
Washington District of Columbia, 20010, United States More Info
Anteneh Tesfaye, MD
Principal Investigator
Mayo Clinic
Jacksonville Florida, 32224, United States More Info
Jeremy Jones, MD
Principal Investigator
Louisiana State University Health Sciences Center - New Orleans
New Orleans Louisiana, 70112, United States More Info
John Stewart, MD
Principal Investigator
Mayo Clinic
Rochester Minnesota, 55905, United States More Info
Joleen Hubbard, MD
Principal Investigator
Renown Regional Medical Center
Reno Nevada, 89502, United States More Info
Lee Schwartzberg, MD
Principal Investigator
The University of Tennessee Medical Center
Knoxville Tennessee, 37920, United States More Info
James Mosley, MD
Principal Investigator
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Michael S Lee, MD
Principal Investigator
Intermountain Medical Center
Saint George Utah, 84790, United States More Info
Terence Rhodes, MD, PhD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Estimated Enrollment:

180

Study ID:

NCT05189171

Recruitment Status:

Recruiting

Sponsor:


Xilis, Inc.

How clear is this clinincal trial information?

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