The combination of temozolomide (TEM) and interferon-alpha (IFN-alpha) previously demonstrated a 30% response rate in metastatic melanoma. A single institution, phase II trial evaluating the efficacy of TEM/IFN in patients with advanced renal cell carcinoma (RCC) was conducted. Safety and tumor response were the main outcomes. Eligible patients received 200 mg/m(2)/day TEM orally on days 1-5 every 28 days, with IFN 2.5 million U/m(2)/day subcutaneously (s.c.) three alternate days/week for days 1-15 first cycle, then 5 million U/m(2)/day s.c. 3 alternate days/week throughout each 28-day cycle. Efficacy was evaluated every 8 weeks, and dose-limiting toxicities (DLTs) were treated with dose reductions of the culprit drug. Sixteen patients (ages 37-67) were initially enrolled. Of the 14 evaluable patients, there was one minor response. Best response was stable disease, with 7 patients remaining on study for > or =6 months. Five were alive for more than 2 years, and 2 remain alive at 45 and 50 months after enrollment. DLTs included TEM-induced myelosuppression and IFN-induced fever/chills. Other toxicities were mild to moderate (grades 1-3). The combination of TEM/IFN proved quite tolerable. This regimen appears inactive in terms of response in this population with poor prognosis, but the patients with stable disease > or =6 months remain of interest.
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http://dx.doi.org/10.1089/107999004772719891 | DOI Listing |
BAY 2413555 is a novel selective and reversible positive allosteric modulator of the type 2 muscarinic acetylcholine (M2) receptor, aimed at enhancing parasympathetic signaling and restoring cardiac autonomic balance for the treatment of heart failure (HF). This study tested the safety, tolerability and pharmacokinetics of this novel therapeutic option. REMOTE-HF was a multicenter, double-blind, randomized, placebo-controlled, phase Ib dose-titration study with two active arms.
View Article and Find Full Text PDFNat Commun
December 2024
Laboratory of Aging Research and Cancer Drug Target, National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University, Chengdu, China.
The immune escape capacities of XBB variants necessitate the authorization of vaccines with these antigens. In this study, we produce three recombinant trimeric proteins from the RBD sequences of Delta, BA.5, and XBB.
View Article and Find Full Text PDFHere we report results of a phase 1 multi-institutional, open-label, dose-escalation trial (NCT02744287) of BPX-601, an investigational autologous PSCA-directed GoCAR-T® cell product containing an inducible MyD88/CD40 ON-switch responsive to the activating dimerizer rimiducid, in patients with metastatic pancreatic (mPDAC) or castration-resistant prostate cancer (mCRPC). Primary objectives were to evaluate safety and tolerability and determine the recommended phase 2 dose/schedule (RP2D). Secondary objectives included the assessment of efficacy and characterization of the pharmacokinetics of rimiducid.
View Article and Find Full Text PDFAndrology
December 2024
Interdisciplinary Department of Medicine, School of Medicine, University of Bari "Aldo Moro", Bari, Italy.
Background: Evidence indicates a wide range of andrological alterations in patients with the Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) infection and Coronavirus Disease 2019 (COVID-19).
Aim: To provide an update on the andrological effects of SARS-CoV-2 infection and COVID-19.
Methods: PubMed/MEDLINE and Institutional websites were searched for randomized clinical trials, non-systematic reviews, systematic reviews, and meta-analyses.
JMIR Form Res
December 2024
Department of Psychiatry & Behavioral Sciences, University of Minnesota, Minneapolis, MN, United States.
Background: Anxiety disorders are common in alcohol use disorder (AUD) treatment patients. Such co-occurring conditions ("comorbidity") have negative prognostic implications for AUD treatment outcomes, yet they commonly go unaddressed in standard AUD care. Over a decade ago, we developed and validated a cognitive behavioral therapy intervention to supplement standard AUD care that, when delivered by trained therapists, improves outcomes in comorbid patients.
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