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COX-2 Inhibitor

Chemokine Modulation Therapy for Breast Cancer

Phase < 1
Waitlist Available
Led By Shipra Gandhi, MD
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that combines two drugs. The first drug is given to 'unleash' the patient's existing immune response to cancer. The second drug is an antibody that may help prevent the cancer from growing and spreading.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall response rate (ORR) as measured by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) criteria 1.1
Secondary outcome measures
Disease control rate (DCR) as measured by irRECIST 1.1 criteria
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Overall survival (OS) as measured by irRECIST 1.1 criteria
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (chemokine modulation therapy)Experimental Treatment6 Interventions
Participants undergo pre-treatment biopsy. Participants then undergo chemokine modulation therapy consisting of celecoxib PO BID, recombinant interferon alfa-2b IV over 20 minutes, and rintatolimod IV over 30-60 minutes on days -11 to -9, and -4 to -2. Participants then undergo additional biopsy. Following biopsy and chemokine modulation therapy, participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rintatolimod
2019
Completed Phase 2
~120
Pembrolizumab
2017
Completed Phase 2
~2010
Biopsy
2014
Completed Phase 4
~1090
Chemokine Modulation Therapy
2019
Completed Early Phase 1
~10
Celecoxib
2019
Completed Phase 4
~1740
Recombinant Interferon Alfa-2b
2019
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
30,799 Total Patients Enrolled
10 Trials studying Breast Cancer
1,638 Patients Enrolled for Breast Cancer
AIM ImmunoTech Inc.Industry Sponsor
14 Previous Clinical Trials
700 Total Patients Enrolled
Shipra Gandhi, MDPrincipal InvestigatorRoswell Park Cancer Institute
2 Previous Clinical Trials
177 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Chemokine Modulation Therapy and Pembrolizumab in Treating Participants With Metastatic Triple-Negative Breast Cancer
2019. "Chemokine Modulation Therapy and Pembrolizumab in Treating Participants With Metastatic Triple-Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03599453.
~1 spots leftby Apr 2025
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