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Publications (29)
A recent analysis from the MPACT trial supported the use of carbohydrate antigen 19-9 (CA19-9) decrease as a predictive marker for survival in patients receiving nab-paclitaxel plus gemcitabine or gemcitabine alone for metastatic pancreatic cancer; however, CA19-9 cannot be used in this capacity for the 15% to 20% of patients who do not produce ele...
Background:
A phase I/II study and subsequent phase III study (MPACT) reported significant correlations between CA19-9 decreases and prolonged overall survival (OS) with nab-paclitaxel plus gemcitabine (nab-P+Gem) treatment for metastatic pancreatic cancer (MPC). CA19-9 changes at week 8 and potential associations with efficacy were investigated a...
Background
In a phase 1-2 trial of albumin-bound paclitaxel (nab-paclitaxel) plus gemcitabine, substantial clinical activity was noted in patients with advanced pancreatic cancer. We conducted a phase 3 study of the efficacy and safety of the combination versus gemcitabine monotherapy in patients with metastatic pancreatic cancer. Methods
We random...
A hypoxic microenvironment is believed to be a characteristic of solid tumors including pancreatic adenocarcinoma (PAC) and is associated with resistance to chemotherapy. The hypoxia-activated prodrug, TH-302, is designed to specifically target the hypoxic microenvironment. Combining G with TH-302 may enable the targeting of both the normoxic and h...
Background: INK128 is an orally bioavailable potent and selective ATP site kinase inhibitor of mammalian target of rapamycin (mTOR) complexes TORC1 and TORC2 that play a crucial role in regulating tumor cell growth, metabolism and motility. INK128 is structurally and mechanistically distinct from rapamycin and rapalogs. mTOR activity is frequently...
Bosutinib, a potent ATP-competitive, quinolinecarbonitrile Src/Abl kinase inhibitor, was tested in this first-in-human phase I trial in patients with advanced solid tumor malignancies. Patients and Methods: This trial was conducted in 2 parts. In part 1 (dose escalation), increasing oral bosutinib doses were administered using a 3 + 3 design. In pa...
Unlabelled:
Satraplatin is a novel platinum agent with favorable clinical attributes including oral bioavailability and lack of significant treatment-associated neuropathy and nephropathy. Furthermore, preclinical studies have shown that satraplatin is active is cisplatin-resistant tumors. We retrospectively evaluated the activity of satraplatin i...
The objectives of this phase 1, first-in-human study were to determine the dose-limiting toxicities (DLT), maximum tolerated dose (MTD), safety, pharmacokinetics, and preliminary activity of the hypoxia-activated prodrug TH-302 in patients with advanced solid tumors.
TH-302 was administered intravenously over 30 to 60 minutes in two regimens: three...
Immunosuppressive tumor microenvironments can restrain antitumor immunity, particularly in pancreatic ductal adenocarcinoma
(PDA). Because CD40 activation can reverse immune suppression and drive antitumor T cell responses, we tested the combination
of an agonist CD40 antibody with gemcitabine chemotherapy in a small cohort of patients with surgica...
To determine the maximum tolerated dose (MTD), safety, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity of CT-322 (BMS-844203), a VEGFR-2 inhibitor and the first human fibronectin domain-based targeted biologic (Adnectin) to enter clinical studies.
Patients with advanced solid malignancies were treated with esc...
To prospectively evaluate the utility of dynamic contrast material-enhanced magnetic resonance (MR) imaging in predicting the response of locally advanced pancreatic cancer to combined chemotherapy and antiangiogenic therapy.
This prospective, institutional review board-approved, HIPAA-compliant study with informed consent assessed dynamic contrast...
3043 Background: Prior data of dual VEGF-ligand/receptor blockade with B and S showed promising efficacy. P is active against many tumor types, and combined with B improves efficacy in breast and lung cancers. We conducted a phase I study to determine the safety and MTD of P with B and S. Methods: Eligible pts had good organ function, ECOG PS 0-1,...
Hypoxia is a defining feature of solid tumors, including prostate cancer. Metastases also exhibit subregional hypoxia and micrometastases may be severely hypoxic. Hypoxic cells are known to be resistant to standard chemotherapies and thus play a role in treatment failure and disease relapse. TH‐302, a tumor‐selective hypoxia‐activated prodrug of th...
Duodenal adenocarcinoma (DA) is rare, but potentially curable. Prospective data on treatment outcomes is scarce and large retrospective studies show conflicting results on the impact of radical resection, node-status, and adjuvant therapy.
In the past 17 years, 30 patients presented with resectable DA. Data on the aforementioned variables were acqu...
A dose-escalation study of glufosfamide plus gemcitabine showed that the combination could be administered safely at full doses. The purpose of this phase II study was to evaluate the safety and efficacy of this combination in chemotherapy-naive pancreatic adenocarcinoma.
Eligible patients had metastatic and/or locally advanced pancreatic adenocarc...
Learning Objectives
After completing this course, the reader will be able to: Discuss the natural history of locally advanced pancreatic cancer, compared with resectable or metastatic pancreatic cancer.Describe the palliative management of obstruction, celiac plexus pain, and bleeding.Evaluate various combinations of chemotherapy and radiation.Disc...
We studied the effect of donor chimerism level on the outcome of donor lymphocyte infusion (DLI) therapy in 42 patients with persistent or relapsed hematologic malignancies after non-T cell-depleted allogeneic hematopoietic cell transplantation. Seventy-five percent of chronic myelogenous leukemia (CML) and 39% of non-CML patients entered remission...
Trastuzumab as a single agent has activity in metastatic breast cancer; however, the mechanism of action for this clinical activity is uncertain. Whereas interruption of erbB family member signaling occurs, trastuzumab also mediates antibody-dependent cellular cytotoxicity in vitro and in vivo. Based on these data, a clinical trial was performed to...
Natural killer (NK) cells decrease in function during chronic myelogenous leukemia (CML) progression from chronic phase to blast crisis, and they can become BCR/ABL(+) late in the disease course. To study this altered function, NK92 cells were transduced with the BCR/ABL oncogene. In contrast to the parental cells, which died when deprived of inter...
