Clinical Trials Directory

Trials / Completed

CompletedNCT04081389

Chemokine Modulation Therapy and Standard Chemotherapy Before Surgery for the Treatment of Early Stage Triple Negative Breast Cancer

Phase I Clinical Trial Assessing the Combination of Chemokine Modulation With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
9 (actual)
Sponsor
Roswell Park Cancer Institute · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase I trial studies how well chemokine modulation therapy and standard chemotherapy given before surgery work in treating patients with early stage triple negative breast cancer. Chemokine modulation therapy, including celecoxib, recombinant interferon alfa-2b, and rintatolimod, may stimulate the immune system and stop tumor cells from growing. Drugs used in standard chemotherapy, such as paclitaxel, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemokine modulation therapy together with standard chemotherapy may work better than giving either therapy alone in treating patients with triple negative breast cancer.

Detailed description

PRIMARY OBJECTIVE: I. To examine the safety and tolerability profile of the combination of rintatolimod celecoxib +/- interferon alpha-2b, when given as CKM along with chemotherapy in the neoadjuvant setting in early stage triple negative breast cancer. II To identify the appropriate dose level of CKM and paclitaxel for future clinical exploration. SECONDARY OBJECTIVES: II. • Evaluate the effect of neoadjuvant CKM + paclitaxel on pathological response and breast MRI response in early stage triple negative breast cancer patients. III. • Evaluate the overall and recurrence-free survival in early stage triple negative breast cancer patients that received neoadjuvant CKM + paclitaxel. EXPLORATORY OBJECTIVES: I• To evaluate longitudinal changes of blood biomarkers such as peripheral T-cell subsets, myeloid derived suppressor cells (MDSC), expression of chemokine and other immune genes, circulating immune mediators and correlate them with the clinical course post surgery. II• Comparison of response assessment criteria for a prospective analysis using RECIST 1.1. and irRECIST * Evaluate changes in the intratumoral levels of biomarkers, such as, peripheral T-cell subsets, myeloid derived suppressor cells (MDSC), chemokines, and immune-regulatory factors (pre- vs post-CKM + paclitaxel treatment). OUTLINE: This is a phase Ib, dose-escalation study of recombinant interferon alfa-2b. Patients receive celecoxib orally (PO) twice daily (BID), recombinant interferon alfa-2b intravenously (IV) over 20 minutes (omitted in lowest dose level), and rintatolimod IV on days 1-3 of weeks 1-3, as well as paclitaxel IV over 1 hour once weekly on day 1. Treatment continues for a total of 12 weeks in the absence of disease progression or unacceptable toxicity. 1-3 weeks after last dose of paclitaxel, patients receive doxorubicin IV over 10 minutes and cyclophosphamide IV over 30 minutes. Treatment repeats every 2 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. . After completion of study treatment, patients are followed up at 2 weeks.

Conditions

Interventions

TypeNameDescription
DRUGCelecoxibGiven PO
DRUGCyclophosphamideGiven IV
DRUGDoxorubicinGiven IV
DRUGDoxorubicin HydrochlorideGiven IV
DRUGPaclitaxelGiven IV
BIOLOGICALRecombinant Interferon Alfa-2bGiven IV
DRUGRintatolimodGiven IV

Timeline

Start date
2019-12-06
Primary completion
2022-05-24
Completion
2023-02-27
First posted
2019-09-09
Last updated
2023-09-11
Results posted
2023-09-11

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04081389. Inclusion in this directory is not an endorsement.