Publications by authors named "Melinda Downs"
Article Synopsis
- - The study involved 24 women with breast cancer, split evenly between hormone receptor-positive and advanced triple-negative types, treated with a combination of entinostat, nivolumab, and ipilimumab.
- - Results showed no severe side effects and indicated a 25% overall response rate, with better outcomes (40%) in triple-negative patients compared to hormone receptor-positive (10%).
- - The treatment yielded a 40% clinical benefit rate and a 50% progression-free survival rate at 6 months, suggesting further research in a phase II trial is warranted.
Article Synopsis
- The study evaluates the combination of the histone deacetylase inhibitor entinostat with immune checkpoint inhibitors (ICIs) nivolumab and ipilimumab in patients with advanced solid tumors, aiming to enhance treatment efficacy.
- Thirty-three patients participated in the trial, experiencing treatment-related side effects like fatigue and anemia, while the recommended phase II dosing was determined to be 3 mg of entinostat weekly, along with specified doses of nivolumab and ipilimumab.
- Results showed a 16% objective response rate, including a complete response in a case of triple-negative breast cancer, and a significant increase in CD8 effector to FoxP3 regulatory T cell ratios, highlighting the
Purpose: Romidepsin dosing recommendations for patients with malignancy and varying degrees of hepatic dysfunction was lacking at the time of regulatory approval for T-cell lymphoma. We conducted a multicenter phase I clinical trial (ETCTN-9008) via the NCI Organ Dysfunction Working Group to investigate safety, first cycle MTD, and pharmacokinetic profile of romidepsin in this setting.
Patients And Methods: Patients with select advanced solid tumors or hematologic malignancies were stratified according to hepatic function.
Background: Epigenetic abnormalities are manifold in all solid tumors and include changes in chromatin configuration and DNA methylation. The authors designed a phase 1 study to evaluate the oral DNA methyltransferase inhibitor CC-486 combined with the histone deacetylase inhibitor romidepsin in advanced solid tumors with dose expansion to further evaluate pharmacodynamics and possible clinical benefit of the recommended phase 2 dose (RP2D).
Methods: This was a phase 1 study with a 3 + 3 dose-escalation design and an expansion phase for patients with virally mediated cancers.