Chemokine-Modulatory Regimen for Recurrent Resectable Colorectal Cancer

• Status: Terminated
• Trial end date: 2017-04-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pawel Kalinski; Roswell Park Cancer Institute
• Collaborators: AIM ImmunoTech Inc.; Hemispherx Biopharma
• Treatments: Celecoxib; Interferon alpha-2; Interferon-alfa-1b; Interferon-alpha; Interferons; Poly I-C; poly(I).poly(c12,U)

Criteria

Inclusion:

• Recurrent and/or metastatic resectable colorectal cancer, including disease within the abdomen and pelvis with no evidence of extra-abdominal metastases. Isolated resectable pulmonary metastasis are allowable in the absence of intra-abdominal metastasis. Intra-abdominal disease includes: isolated hepatic metastasis/metastases (see next inclusion criteria point), isolated peritoneal metastasis, peritoneal carcinomatosis (including patients undergoing cytoreductive surgery alone or in combination with hyperthermic intraperitoneal chemoperfusion - HIPEC), or a combination of hepatic and extrahepatic metastasis.

• 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.

• Patient must be able to understand and be willing to sign a written informed consent document.

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 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.