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NCT03403634 · ClinicalTrials.gov registry record · Phase 2
Celecoxib, Recombinant Interferon Alfa-2b, and Rintatolimod in Treating Patients With Colorectal Cancer Metastatic to the Liver
A Phase 2 study of Stage IV Colorectal Cancer AJCC v7 and Stage IVA Colorectal Cancer AJCC v7, sponsored by Roswell Park Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT03403634: Completed Phase 2 study of Stage IV Colorectal Cancer AJCC v7 and Stage IVA Colorectal Cancer AJCC v7, sponsored by Roswell Park Cancer Institute.
NCT03403634 is a Phase 2 study of Stage IV Colorectal Cancer AJCC v7 and Stage IVA Colorectal Cancer AJCC v7 that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 19 participants, below the 84-participant average among 7 other Stage IV Colorectal Cancer AJCC v7 trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03403634, a Phase 2 study of Stage IV Colorectal Cancer AJCC v7 and Stage IVA Colorectal Cancer AJCC v7, has completed, sponsored by Roswell Park Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The TILs will be summarized by time-point (pre-/post-treatment) using the mean, median, standard deviation; and graphically using dot-plots. The TIL of interest is CD8a expression, which is reported as the mean fold change from pre-treatment (i.e. post treatment / pre treatment).
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Celecoxib
- BIOLOGICAL Recombinant Interferon Alfa-2b
- DRUG Rintatolimod
Study Locations (1)
New York
- Roswell Park Cancer Institute - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2018-04-19 |
| Est. Completion | 2021-08-29 |
| Phase | Phase 2 |
What the finished NCT03403634 record still lists
NCT03403634 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 84-participant average among 7 other Stage IV Colorectal Cancer AJCC v7 trials with a reported enrollment target (77% lower).
The record links to 5 conditions, with Stage IV Colorectal Cancer AJCC v7 appearing as the primary indexed condition, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT03403634 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03403634 about?
NCT03403634 is a clinical study titled "Celecoxib, Recombinant Interferon Alfa-2b, and Rintatolimod in Treating 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 inter...
What is the current status of trial NCT03403634?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2018-04-19. Estimated completion is 2021-08-29.
What conditions does trial NCT03403634 study?
This clinical trial studies the following conditions: Stage IV Colorectal Cancer AJCC v7, Stage IVA Colorectal Cancer AJCC v7, Stage IVB Colorectal Cancer AJCC v7, Recurrent Colorectal Carcinoma, Metastatic Carcinoma in the Liver.
What interventions are being tested in trial NCT03403634?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Celecoxib (DRUG), Recombinant Interferon Alfa-2b (BIOLOGICAL), Rintatolimod (DRUG).
Who is sponsoring clinical trial NCT03403634?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03403634 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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