Chemokine-Modulatory Regimen for Recurrent Resectable Colorectal Cancer (NCT01545141) | Clinical Trial Compass
TerminatedPhase 1/2
Chemokine-Modulatory Regimen for Recurrent Resectable Colorectal Cancer
United States15 participantsStarted 2012-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Change in the Number of Tumor-infiltrating CD8+ Cells.