Chemokine-Modulatory Regimen for Recurrent Resectable Colorectal Cancer
Randomized Phase 1/2 Evaluation of Neoadjuvant Administration of a Chemokine-Modulatory Regimen in Patients With Recurrent Resectable Colorectal Cancer
1 other identifier
interventional
15
1 country
1
Brief Summary
Determine the safety of a combination of IFN, celecoxib, and rintatolimod for patients with recurrent colorectal cancer. This will also test whether the above combination can help the immune system to fight the tumors. The results will allow the investigators to determine the "preferred" combination for subsequent extended studies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 colorectal-cancer
Started Oct 2012
Typical duration for phase_1 colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 29, 2012
CompletedFirst Posted
Study publicly available on registry
March 6, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 8, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 8, 2017
CompletedResults Posted
Study results publicly available
September 9, 2020
CompletedOctober 27, 2023
October 1, 2023
3.5 years
February 29, 2012
July 14, 2020
October 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the Number of Tumor-infiltrating CD8+ Cells.
This will be assessed by the increase in the total number of tumor-infiltrating CD8+ T cells in the resected, recurrent CRC lesions (measured as the ratio between the CD8 mRNA message and the expression of the housekeeping gene HPRT), comparing Arm A and Arm B.
Day of surgery: day 8-10
Secondary Outcomes (1)
Treatment Related Adverse Events
1 week
Study Arms (4)
Surgery only
NO INTERVENTIONSurgical resection only, performed as standard of care for the disease
Chemokin Modulatory Regimen (5 MU/m2)
EXPERIMENTALChemokine Modulatory Regimen monday through Friday prior to surgery: 400 mg celecoxib for 5 days IFN by intravenous infusion (IV) (Phase 1 dose escalation of 5 MU/m2) for 5 days Rintatolimod 200 mg by IV infusion for 5 days
Chemokin Modulatory Regimen (10 MU/m2)
EXPERIMENTALChemokine Modulatory Regimen monday through Friday prior to surgery: 400 mg celecoxib for 5 days IFN by intravenous infusion (IV) (Phase 1 dose escalation of 10 MU/m2) for 5 days Rintatolimod 200 mg by IV infusion for 5 days
Chemokin Modulatory Regimen (20 MU/m2)
EXPERIMENTALChemokine Modulatory Regimen monday through Friday prior to surgery: 400 mg celecoxib for 5 days IFN by intravenous infusion (IV) (Phase 1 dose escalation of 20 MU/m2) for 5 days Rintatolimod 200 mg by IV infusion for 5 days
Interventions
Celecoxib: 200 mg twice/day M-F of the week prior to scheduled surgery rintatolimod: 200 mg i.v. administration M-F of the week prior to scheduled surgery IFN: i.v. administration, M-F of the week prior to scheduled surgery. Dose escalation evaluating 5, 10, and 20 MU/m2.
Celecoxib: 200 mg twice/day M-F of the week prior to scheduled surgery rintatolimod: 200 mg i.v. administration M-F of the week prior to scheduled surgery
Celecoxib: 200 mg twice/day M-F of the week prior to scheduled surgery rintatolimod: 200 mg i.v. administration M-F of the week prior to scheduled surgery
Eligibility Criteria
You may qualify if:
- Patients with isolated hepatic metastasis must satisfy a Clinical Risk Score of 3 or higher (see Appendix C)
- Eligible patients are expected to have a complete resection based on preoperative imaging. Any patient not found to be able to have complete resection will not be eligible for this study.
- No chemotherapy, radiotherapy, major surgery, or biologic therapy within 3 weeks of protocol treatment
- An ECOG performance status of 0, 1, or 2.
- Age equal to 18 years or older.
- Must have normal organ and marrow function as defined below:
- Platelet ≥ 75,000/µL
- Hemoglobin ≥ 9.0 g/dL
- Hematocrit ≥ 27.0%
- Absolute Neutrophil Count (ANC) ≥ 1500/µL
- Creatinine \< institutional upper limit of normal (ULN) OR
- Creatinine clearance ≥ 50 mL/min/1.73 m2 for patients with creatinine levels greater than ULN
- Total bilirubin ≤ 1.5 X institutional upper limit of normal (ULN)
- AST(SGOT) and ALT(SGPT) ≤ 2.5 X institutional upper limit of normal (ULN)
- Serum amylase and lipase within normal limits.
- +1 more criteria
You may not qualify if:
- Patients currently treated with systemic immunosuppressive agents, including steroids, are ineligible until 3 weeks after removal from immunosuppressive treatment.
- Patients with active autoimmune disease 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.
- Patients with comorbid medical conditions that render them unfit for surgery.
- Metastatic or recurrent disease that is deemed partially resectable or unresectable based on preoperative imaging.
- Metastatic disease outside the confines of the abdomen, pelvis and thorax (e.g bone, brain)
- 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 (Appendix A)
- 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 sulfonamides, celecoxib, or NSAIDs.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Roswell Park Cancer Institutelead
- AIM ImmunoTech Inc.collaborator
Study Sites (1)
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kris Attwood
- Organization
- Roswell Park Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Amer H Zureikat, MD
University of Pittsburgh
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 29, 2012
First Posted
March 6, 2012
Study Start
October 1, 2012
Primary Completion
April 8, 2016
Study Completion
April 8, 2017
Last Updated
October 27, 2023
Results First Posted
September 9, 2020
Record last verified: 2023-10