Clinical Trials Directory

Trials / Completed

CompletedNCT03403634

Celecoxib, Recombinant Interferon Alfa-2b, and Rintatolimod in Treating Patients With Colorectal Cancer Metastatic to the Liver

Phase 2a Study Evaluating a Chemokine-Modulatory Regimen in Patients With Colorectal Cancer Metastatic to the Liver

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
19 (actual)
Sponsor
Roswell Park Cancer Institute · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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 the growth of tumor cells by blocking some of the enzymes needed for cell growth. Recombinant interferon alfa-2b is a substance that can improve the body's natural response and may interfere with the growth of tumor cells. Rintatolimod may stimulate the immune system. Giving celecoxib, recombinant interferon alfa-2b, and rintatolimod may work better at treating colorectal cancer that has spread to the liver.

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 T-lymphocyte (CTL) marker (CD8a gene expression) to regulatory T cell (Treg) markers (FoxP3 gene expression). SECONDARY OBJECTIVES: I. Estimate the objective response rate of a chemokine-modulatory regimen in metastatic colorectal cancer (per Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1). II. Examine the safety and tolerability profile of the combination of recombinant interferon alfa-2b (interferon alpha-2b), rintatolimod, and celecoxib when given as chemokine modulation to colorectal cancer patients prior to surgical resection using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.0). TERTIARY OBJECTIVES: * Estimate the median progression free survival of a chemokine-modulatory regimen in metastatic colorectal cancer * Estimate overall survival in participants with recurrent and/or metastatic unresectable colorectal cancer who received the chemokine-modulatory regimen * Comparison (using RT-PCR, immunofluorescence \[IF\] and immunohistochemistry \[IHC\] on serial sections) of the metastatic tissue specimen with regard to total numbers of infiltrating T cells, their CD4/CD8 ratios, frequencies of FoxP3 cells, and the expression of chemokine receptors on CD4+ and CD8+ T cells (CXCR3, CCR5, CCR4, CCR6, and CXCR4) * Evaluate the local expression of effector T cells (Teff)-attracting chemokines (CCR5, CXCL9, CXCL10 and CXCL11) and Treg-favoring chemokines (CCL22 and CXCL12) using IF and RT-PCR. OUTLINE: Patients receive celecoxib orally (PO) twice daily (BID), recombinant interferon alfa-2b intravenously (IV) over 20 minutes, and rintatolimod IV QD on days 1, 2,3,8,9,10,15,16 and 17 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for up to 12 months.

Conditions

Interventions

TypeNameDescription
DRUGCelecoxibGiven PO
OTHERLaboratory Biomarker AnalysisCorrelative studies
BIOLOGICALRecombinant Interferon Alfa-2bGiven IV
DRUGRintatolimodGiven IV

Timeline

Start date
2018-04-19
Primary completion
2020-12-23
Completion
2021-08-29
First posted
2018-01-18
Last updated
2022-03-02
Results posted
2022-03-02

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03403634. Inclusion in this directory is not an endorsement.