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

NCT03403634 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2022-03-02

Study results available
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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.

Conditions

  • Metastatic Carcinoma in the Liver
  • Recurrent Colorectal Carcinoma
  • Stage IV Colorectal Cancer AJCC v7
  • Stage IVA Colorectal Cancer AJCC v7
  • Stage IVB Colorectal Cancer AJCC v7

Interventions

DRUG

Celecoxib

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Recombinant Interferon Alfa-2b

Given IV

DRUG

Rintatolimod

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Roswell Park Cancer Institute

    lead OTHER

Principal Investigators

  • Sarbajit Mukherjee, MD · Roswell Park Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-19
Primary Completion
2020-12-23
Completion
2021-08-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03403634 on ClinicalTrials.gov