532 Multicenter, Prospective Randomized Phase IIB Study of Endoscopic Ultrasound Guided Intratumoral Injection of OncoGel™ (Regel™/Paclitaxel) As a Component of Neoadjuvant Chemoradiotherapy for Local or Loco-Regional Operable Esophageal Cancer - Interim Safety Results

DeWitt, John M.; Krishnamurthy, Sairam; Ardhanari, Ramesh; Neoral, C; Nosek, Vladimír; DuVall, G.A.; Kamiński, Marek; Wallner, Grzegorz; Litka, Paul; Daugherty, Claire; Fowers, Kirk D.

doi:10.1016/j.gie.2011.03.078

Cited by 3 publications

(3 citation statements)

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“…Phase 2b clinical trial was conducted by combining OncoGel and chemoradiotherapy for 154 randomized esophageal cancer patients subsequently undergoing surgery, OncoGel/Chemoradiotherapy (CRT) (n = 78) or CRT alone (n = 76). 127 Combination of intratumoral OncoGel injection and CRT was well tolerated, without a notable increase in systemic side effects. However, OncoGel failed to demonstrate enhancement in efficacy of chemoradiotherapy in localized delivery of paclitaxel compared with systemic administration.…”

Section: Degradation Mechanism Of Thermoresponsivementioning

confidence: 93%

“…These promising data spurred clinical development. Phase 2b clinical trial was conducted by combining OncoGel and chemoradiotherapy for 154 randomized esophageal cancer patients subsequently undergoing surgery, OncoGel/Chemoradiotherapy (CRT) ( n = 78) or CRT alone ( n = 76) . Combination of intratumoral OncoGel injection and CRT was well tolerated, without a notable increase in systemic side effects.…”

Section: Introductionmentioning

confidence: 99%

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Thermogels: In Situ Gelling Biomaterial

Liow

Dou

Kai

et al. 2016

ACS Biomater. Sci. Eng.

193

162

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In situ gel delivery systems are preferred over conventional systems due to sustained and prolonged release action of therapeutic payload onto the targeted site. Thermogel, a form of in situ gel-forming polymeric formulation, undergoes sol–gel transition after administration into the body. At room temperature, the system is an aqueous polymer solution that easily entraps therapeutic payload by mixing. Upon injection, the higher physiological temperature causes gelation in situ because of the presence of thermosensitive polymers. The gel degrades gradually over time, allowing sustained release of therapeutics localized to the site of interest. This minimizes systemic toxicity and improved efficacy of drug release to the targeted site. Thermogel properties can be easily altered for specific applications via substitution and modification of components in diblock and triblock copolymer systems. The feasibility of fine-tuning allows modifications to biodegradability, biocompatibility, biological functionalization, mechanical properties, and drug release profile. This review summarized recent development in thermogel research with a focus on synthesis and self-assembly mechanisms, gel biodegradability, and applications for drug delivery, cell encapsulation and tissue engineering. This review also assessed inadequacy of material properties as a stand-alone factor on therapeutic action efficacy in human trials, with a focus on OncoGel, an experimental thermogel that demonstrated excellent individual or synergistic drug delivery system in preclinical trials but lacked therapeutic impact in human trials. Detailed analysis from all aspects must be considered during technology development for a successful thermogel platform in drug delivery and tissue engineering.

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Section: Degradation Mechanism Of Thermoresponsivementioning

confidence: 93%

Section: Introductionmentioning

confidence: 99%

Thermogels: In Situ Gelling Biomaterial

Liow

Dou

Kai

et al. 2016

ACS Biomater. Sci. Eng.

193

162

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“…OncoGel (MacroMed, Sandy, Utah, USA) is a paclitaxel formulation that utilizes a thermosensitive, biodegradable copolymer called ReGel (MacroMed) as a drug delivery system, offering extended paclitaxel release for focused cytotoxicity and continuous radiosensitization without systemic toxicity. In an international multicenter, prospective randomized study [15], patients with local or locoregional adenocarcinoma or squamous cell carcinoma of the esophagus/gastroesophageal junction (Stages IIA, IIB, III, and IVA), who were eligible for neoadjuvant chemoradiotherapy (CRT) and surgery were enrolled. Patients were randomized to receive either CRT or CRT plus EUS-guided OncoGel injection.…”

Section: Eus-guided Fine Needle Injection Of Therapeutic Agents !mentioning

confidence: 99%

The year of improved tissue acquisition, randomized trials, and endoscopic ultrasound-guided therapy

Bhutani

2011

Endoscopy

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Presentations at this year's Digestive Disease Week (DWW; 7-10 May, 2011; Chicago, Illinois, USA) reflected a very active year for endoscopic ultrasound (EUS). There were numerous abstracts on EUS-guided fine-needle aspiration (FNA) and core biopsy to improve tissue acquisition, improve diagnostic accuracy, and indeed go beyond routine cytology and tissue diagnosis. EUS-guided therapy including drainage, anastomoses, injection of therapeutic agents, and ablation were other common themes with a lot of new information presented, much of which was obtained from randomized trials. This review discusses in detail some of the abstracts that followed a common theme. Additional interesting abstracts on this topic are listed at the end of the review.

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