Status:
COMPLETED
Celecoxib, Recombinant Interferon Alfa-2b, and Rintatolimod in Treating Patients With Colorectal Cancer Metastatic to the Liver
Lead Sponsor:
Roswell Park Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Metastatic Carcinoma in the Liver
Recurrent Colorectal Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This early phase IIA trial studies how well celecoxib, recombinant interferon alfa-2b, and rintatolimod work in treating patients with colorectal cancer that as spread to the liver. Celecoxib may stop...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the impact of a chemokine-modulatory regimen on the immune microenvironment of colorectal liver metastases, specifically the changes in the ratio between cytotoxic...
Eligibility Criteria
Inclusion
- Recurrent and/or metastatic unresectable colorectal cancer with hepatic metastases
- Hepatic metastases present which are amenable to biopsy
- Prior treatment with, contra-indication to or refusal of a fluoropyrimidine, irinotecan, oxaliplatin and an anti-EGFR targeted therapy (if RAS wild-type \[wt\]) as well as a PD-1 or PD-L1 targeted drug if MSI-H/dMMR
- No chemotherapy, radiotherapy, major surgery, or biologic therapy within 3 weeks of protocol treatment
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Have measurable disease per RECIST 1.1 criteria present
- Ability to swallow and retain oral medication
- Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- Platelet \>= 75,000/uL
- Hemoglobin \>= 9 g/dL
- Hematocrit \>= 27%
- Absolute neutrophil count (ANC) \>= 1500/uL
- Creatinine \< = institutional upper limit of normal (ULN) OR
- Creatinine clearance \>= 50 mL/min for patients with creatinine levels greater than ULN
- Total bilirubin =\< 1.5 X institutional ULN or for patients with known Gilbert's Syndrome total bilirubin \<= 3 x ULN
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X institutional ULN
- Plasma amylase =\< 1.5 X institutional ULN
- Lipase =\< 1.5 X institutional ULN
- Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion
- Patients currently treated with systemic immunosuppressive agents, including steroids, are ineligible until 3 weeks after removal from immunosuppressive treatment
- Patients with active autoimmune disease, requiring ongoing immunosuppressive therapy or history of transplantation
- Patients who are pregnant or nursing; women of childbearing potential (WOCBP) will have to undergo a urine pregnancy test as part of screening
- Untreated central nervous system (CNS) metastases
- Cardiac risk factors including:
- Patients experiencing cardiac event(s) (acute coronary syndrome, myocardial infarction, or ischemia) within 3 months of signing consent
- Patients with a New York Heart Association classification of III or IV
- History of upper gastrointestinal ulceration, upper gastrointestinal bleeding, or upper gastrointestinal perforation within the past 3 years; patients with ulceration, bleeding or perforation in the lower bowel are not excluded
- Prior allergic reaction or hypersensitivity to celecoxib, or non-steroidal antiinflammatory drugs (NSAIDs) or any study agents which would prevent completion of protocol therapy
- Patients are ineligible if they plan on regular use of NSAIDs at any dose more than 2 times per week (on average) or aspirin at more than 325 mg at least three times per week, on average; low-dose aspirin not exceeding 100 mg/day is permitted; patients who agree to stop regular NSAIDs or higher dose aspirin are eligible and no wash out period is required
- Received an investigational agent within 30 days prior to enrollment
- Unwilling or unable to follow protocol requirements
- Patients with known serious mood disorders
- Any additional condition which in the investigator?s opinion deems the participant an unsuitable candidate to receive the study drugs
Key Trial Info
Start Date :
April 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2021
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03403634
Start Date
April 19 2018
End Date
August 29 2021
Last Update
March 2 2022
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263