Type-1-polarized Dendritic Cell Vaccine, Interferon Alpha-2b, Rintatolimod, and Celecoxib in Treating Patients with Chemo-refractory Metastatic Colorectal Cancer

Inclusion Criteria

• Be able to understand and be willing to sign a written informed consent document
• Be HLA-A2 positive
• Have mCRC that has been treated with currently approved standard therapies, including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) therapy, and, if Kirsten rat sarcoma viral oncogene homolog (KRAS) wild type, an anti-epidermal growth factor receptor (EGFR) therapy
• Have at least 1 of the tumor sites that must be amenable to core needle biopsy and this may not be the site of disease used to measure antitumor response
• Have measurable disease based on immune-related response criteria (irRC)
• Performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1
• Platelet >= 75,000/µL
• Hemoglobin >= 9.0 g/dL
• Absolute neutrophil count (ANC) >= 1500/µL
• Creatinine < 1.5 x institutional upper limit of normal (ULN) OR creatinine clearance (CrCl) >= 50 mL/min/1.73 m^2 for subjects with creatinine levels greater than 1.5 x ULN
• Total bilirubin =< 1.5 X institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal (ULN) OR =< 5 x ULN for subjects with liver metastases
• Serum amylase and lipase within normal limits

Exclusion Criteria

• Is currently treated with systemic immunosuppressive agents, including steroids, are ineligible until 3 weeks after removal from immunosuppressive treatment
• Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to a previously administered agent
• Has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Has active autoimmune disease or history of transplantation
• Is a woman of child bearing potential (WOCBP) who are pregnant or nursing
• Has a history of cardiac event(s) (acute coronary syndrome, myocardial infarction, or ischemia) within 3 months of signing consent; subjects with a New York Heart Association classification of III or IV
• Has a history of upper gastrointestinal ulceration, upper gastrointestinal bleeding, or upper gastrointestinal perforation within the past 3 years; subjects with ulceration, bleeding or perforation in the lower bowel are not excluded
• Has prior allergic reaction or hypersensitivity to celecoxib, or nonsteroidal anti-inflammatory drugs (NSAIDs)
• Has an active infection requiring systemic therapy
• Has significant ascites or pleural effusion requiring drainage for symptom relief
• Has known active hepatitis B or hepatitis C infection
• Has history of asthma, or other allergic-type reactions after taking aspirin or other NSAIDs
• Has known serious hypersensitivity reactions to peg-interferon alfa-2b or interferon alfa-2b
• Has autoimmune hepatitis
• Has hepatic decompensation (Child-Pugh score > 6; = class B and C)