Recurrent Colorectal Carcinoma Clinical Trial
Official title:
Phase 2a Study Evaluating a Chemokine-Modulatory Regimen in Patients With Colorectal Cancer Metastatic to the Liver
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00545545 -
Safety/Efficacy Study of Imprime PGG With Cetuximab in Patients With Recurrent/Progressive Colorectal Carcinoma
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT05518032 -
Pembrolizumab and Autologous Dendritic Cells for the Treatment of Refractory Colorectal Cancer (CRC)
|
Phase 2 | |
| Active, not recruiting |
NCT02738606 -
Liver Surgery and Chemotherapy in Treating Patients With Colorectal Cancer With Liver Metastases That Can Be Removed by Surgery and Lung Metastases That Cannot Be Removed by Surgery
|
Phase 2 | |
| Recruiting |
NCT01365169 -
Association Between Health Care Provider (HCP)-Assessed ECOG Performance Status (PS) and Overall Survival, and Objectively Measure of Physical Activity (PA) Levels in Advance-cancer Patients"
|
N/A | |
| Completed |
NCT01522820 -
Vaccine Therapy With or Without Sirolimus in Treating Patients With NY-ESO-1 Expressing Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT04017650 -
Encorafenib, Cetuximab, and Nivolumab in Treating Patients With Microsatellite Stable, BRAFV600E Mutated Unresectable or Metastatic Colorectal Cancer
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT01638533 -
Romidepsin in Treating Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Solid Tumors With Liver Dysfunction
|
Phase 1 | |
| Not yet recruiting |
NCT06307548 -
Fluorescence Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Locally Advanced or Recurrent Colorectal Cancer
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT02873195 -
Capecitabine and Bevacizumab With or Without Atezolizumab in Treating Patients With Refractory Metastatic Colorectal Cancer
|
Phase 2 | |
| Completed |
NCT03095781 -
Pembrolizumab and XL888 in Patients With Advanced Gastrointestinal Cancer
|
Phase 1 | |
| Not yet recruiting |
NCT05883683 -
Molecular Study and Precision Medicine for Colorectal Cancer
|
||
| Completed |
NCT02973672 -
Phase I of SGM-101 in Patients With Cancer of the Colon, Rectum or Pancreas
|
Phase 1/Phase 2 | |
| Terminated |
NCT02650635 -
TLR8 Agonist VTX-2337 and Cyclophosphamide in Treating Patients With Metastatic, Persistent, Recurrent, or Progressive Solid Tumors
|
Phase 1 | |
| Terminated |
NCT02508077 -
FOLFIRI and Panitumumab in Treating Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT03823079 -
Comparison of Interleukin-11 and rhTPO for Recurrent Colorectal Cancer Patients With Thrombocytopenia
|
Phase 2 | |
| Active, not recruiting |
NCT04616183 -
LY3214996 and Cetuximab Alone or in Combination With Abemaciclib for the Treatment of Unresectable or Metastatic Colorectal Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT02713373 -
Cetuximab and Pembrolizumab in Treating Patients With Colorectal Cancer That is Metastatic or Cannot Be Removed by Surgery
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT02188264 -
Selumetinib and Cyclosporine in Treating Patients With Advanced Solid Tumors or Advanced or Metastatic Colorectal Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT02465060 -
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
|
Phase 2 | |
| Completed |
NCT03087591 -
APN401 in Treating Patients With Recurrent or Metastatic Pancreatic Cancer, Colorectal Cancer, or Other Solid Tumors That Cannot Be Removed by Surgery
|
Phase 1 |