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United States Patent (10) Patent No.: US 7,008,633 B2 Yang Et Al

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United States Patent (10) Patent No.: US 7,008,633 B2 Yang Et Al USOO70O8633B2 (12) United States Patent (10) Patent No.: US 7,008,633 B2 Yang et al. (45) Date of Patent: Mar. 7, 2006 (54) LOCAL REGIONAL CHEMOTHERAPY AND 5,257,970 A 11/1993 Dougherty RADIOTHERAPY USING IN SITU 5,470,843 A 11/1995 Stahl et al. HYDROGEL 5,542.935 A 8/1996 Unger et al. 5,571,797 A 11/1996 Ohno et al. (75) Inventors: David J. Yang, Sugar Land, TX (US); 5,656.272 A 8/1997 Le et al. Dong-Fang Yu, Houston, TX (US); Ali 5,702.717. A 12/1997 Cha et al. Azhdarinia, Houston, TX (US); 5.945,100 A * 8/1999 Fick ........................ 424/93.21 Tommy L. Lee, Spring, TX (US); E. 5,977,163 A 11/1999 Li et al. Edmund Kim, Houston, TX (US) 5,989,215 A * 11/1999 Delmotte et al. ............. 604/82 s s 6,004,573 A 12/1999 Rathi et al. (73) Assignee: Board of Regents, The University of 6,117,949 A 9/2000 Rathi et al. Texas System, Austin, TX (US) FOREIGN PATENT DOCUMENTS (*) Notice: Subject to any disclaimer, the term of this JP 10236984 A2 9/1993 patent is extended or adjusted under 35 (Continued) U.S.C. 154(b) by 254 days. OTHER PUBLICATIONS (21) Appl. No.: 10/024,678 Burris III, Howard A., et al., Intratumoral cisplatin/epineph (22)22) Filled: Dec. 18,9 2001 rine-injectable gel as a palliative treatment for accessible Solid tumors: A multicenter pilot center; Head Neck Surg, (65) Prior Publication Data vol. 118; pp. 496-503; 1998. US 2005/0227910 A1 Oct. 13, 2005 (Continued) Related U.S. Application Data Primary Examiner Thurman K. Page Assistant Examiner-Blessing Fubara (60) Eyal application No. 60/256,514, filed on Dec. (74) Attorney, Agent, or Firm-Fulbright & Jaworski, LLP (51) Int. Cl. (57) ABSTRACT A6IF I3/00 (2006.01) A6 IK 9/14 (2006.01) Methods regarding local regional treatment in Situ for an A6 IK 4800 (2006.01) individual, Such as of a tumor, are provided herein. A (52) U.S. Cl. ...................... 424/422,424/484; 424/488; hydrogel composition is generated in situ in the tumor by s 424.93.21 administering a polymer, Such as a polysaccharide or a (58) Field of Classification Search 424/422 polyamino acid, with a therapeutic agent, Such as a radio 424/48 4.48s. 93.21. 60483 nuclide or a drug, and administering a cross-linking agent. See application file for complete search history The hydrogel/therapeutic agent composition is retained in the tumor for Safe and efficient tumor therapy. Alternatively, (56) References Cited a hvdrogelydrog compositionp is 9.generated in Situ in an artery which nourishes a tumor to occlude the artery. U.S. PATENT DOCUMENTS 4,587,268 A 5/1986 Pfirrmann 61 Claims, 9 Drawing Sheets 20 mer-SACDEoP -- CDDP powder 6 O Time (hours) US 7,008.633 B2 Page 2 FOREIGN PATENT DOCUMENTS Miller, Bruce H., et al.; Nonsurgical treatment of basal cell carcinomas with intralesional 5-fluorouracil/epinephrine JP 70974O1 A2 4/1995 injectable gel, Journal of the American Academy of WO WO-OO/OO222 1/2000 Dermatology; vol. 36 (1); pp. 72-77; 1977. WO WO-OO/38651 7/2000 Jackson, John K., et al.; The Suppression of Human Prostate OTHER PUBLICATIONS Tumor Growth in Mice by the Intratumoral Injection of a Slow-Release Polymeric Paste Formulation of Paclitaxel; Downs, Elizabeth C., et al., Calcium Alginate Beads as a Cancer Research; vol. 60, pp. 4146-4151; 2000. Slow-Release System for Delivering Angiogenic Molecules SPECT abnormalities in Landau-Kleffner syndrome; In Vivo and In Vitro; Journal of Cellular Physiology; vol. Journal of Clinical Neuroscience; vol. 6(1), pp. 9-16; 1999. 152: pp. 422-429; 1991. Kitazawa, Hidenori, et al., Microdialysis ASSessment of Smith, Jill P, et al.; Drug retention and distribution after Fibrin Glue Containing Sodium Alginate for Local Delivery intratumoral chemotherapy with fluorouracil/epinephrine of Doxorubicinin Tumor-Bearing Rats; Biol. Pharm. Bull.; injectable gel in human pancreatic cancer Xenografts, vol. 20. Kraus, Jurgen, et al., Alternative promoter usage and tissue Cancer Themother Pharmacol; vol. 44; pp. 267-274; 1999. Specific expression of the mouse Somatostatin receptor 2 Ning, Shoucheng, et al., RadioSensitization by intratumoral gene, Federation of European Biochemical Societies Let administration of cisplatin in a Sustained-release drug ters; vol. 428; pp. 165-170; 1998. delivery System; Radiotherapy and Oncology, Vol. 50, pp. Kuang, Liren, et al., Percutaneous intratumoral injectino of 215-223; 1999. cisplatin microSpheres in tumor-bearing rats to diminish Monga, Satdarshan P.S., et al.; Intratumoral Therapy of Cisplatin/Epinephrine Injectable Gel for Palliation in acute nephrotoxicity; Anti-Cancer Drugs, Vol. 7, pp. 220 Patients With Obstructive Esophageal Cancer; Am J. Clin. 227; 1996. Oncol.; vol. 23(4); pp. 386-392; 2000. * cited by examiner U.S. Patent Mar. 7, 2006 Sheet 1 of 9 US 7,008,633 B2 f t A. g 6.3. - imO 6 1S l 5 (5Vs g -- C N g t C pa init W. ve ta upeds3 pastaat go 2. U.S. Patent Mar. 7, 2006 Sheet 2 of 9 US 7,008,633 B2 ki & ATai is is a its$ E. he a gas & assists his s'''''*is a sing 3 e K O U.S. Patent Mar. 7, 2006 Sheet 3 of 9 US 7,008,633 B2 3uguesia) utings e w swi 9 U.S. Patent Mar. 7, 2006 Sheet 4 of 9 US 7,008,633 B2 55 mg SnCl 0.5 ml 4% CaCl, 0.5 ml 188ReO, (0.5 mCi) Heat at 100°C for 40 min Remove 10 u, add to Preparation of standard blank test tube, count with gamma counter Remove 100 uL from each Preparation of samples sample, add to 3 blank test tubes (A,B,C) containing 0.4 ml Alginate Add 1 mL cold PBS to wash Decant PBS, add 1 mL fresh PBS Remove 100 uL from each Data at time = 0 sample, add to blank test tubes, count with gamma COunter Add 100 uL of cold PBS to each sample Incubate at 37°C and Assay sample 2X per day collect data at desired time points F. 4 U.S. Patent Mar. 7, 2006 Sheet 5 of 9 US 7,008,633 B2 Accumulated Rhenium-188 Release by Hydrogel 4000 35.00 30.00 25.00 ... -- --L. 2O. OO | 15 OO 1000 5.000.00 U. t - O 2 4. 80 30 100 12O 140 TIME (hours) FIG. 5 U.S. Patent Mar. 7, 2006 Sheet 6 of 9 US 7,008,633 B2 % of Rhenium-188 Dose Released by Hydrogel 10.00 -- --- 9.00 - - 8.00 7.00 6.00 5.00 4.00 —-...- - ------ 3.00 - 2.00 1.00 ------ O 20 40 60 80 100 TIME (hours) FIG. 6 U.S. Patent Mar. 7, 2006 Sheet 7 of 9 US 7,008,633 B2 U.S. Patent Mar. 7, 2006 Sheet 8 of 9 US 7,008,633 B2 U.S. Patent Mar. 7, 2006 Sheet 9 of 9 US 7,008,633 B2 0009 (uus eunow Jouni US 7,008,633 B2 1 2 LOCAL REGIONAL CHEMOTHERAPY AND lateral vessels may continue to Supply the tumor cells. RADIOTHERAPY USING IN SITU Therefore, to overcome the problem of conventional TACE, HYDROGEL a better Strategy to improve cancer therapy by TACE should include complete occlusion of tumor vessels, damaging This application claims priority to U.S. Provisional Patent normal tissue as little as possible, and preventing the for Application Ser. No. 60/256,514 filed Dec. 18, 2000. mation of collaterals. Tumor therapy also includes utilization of irradiation of a BACKGROUND OF THE INVENTION tumor for eradication purposes. Brachytherapy methods utilize Small particles or Seeds of radioactivity implanted 1. Field of the Invention into a tumor and are used often in cervical, breast, endome The present invention is directed to the fields of disease trial, proState, and head and neck cancers. However, current therapy, cancer biology, and cancer therapy. More specifi brachytherapy Seed-dispensing methods dictate less than cally, the present invention is directed to providing local desirable loading yields, are more expensive, are cumber regional treatment in an individual in Situ by administering Some to administer, and render a less than ideal treatment a polymer and a croSS-linking agent. More preferably, the 15 response. local regional treatment in Situ is of a tumor in the indi In another technology requiring Surgical intervention, vidual. patients with operable brain tumors, Such as glioblastoma 2. Description of Related Art multiforme, are Subjected to tumor removal through Surgical Systemic administration of anticancer agents often results means, and GLIADEL(R) (Nova Pharmaceutical Corpora in Severe dose-limiting toxic effects. Therefore, Site-specific tion; Baltimore, Md.) biodegradable wafers made of a delivery of anticancer drugs, Such as in local regional polyanhydride, Such as polifeprosan 20, containing a che therapy, is extremely beneficial for Solid tumors. During motherapeutic are inserted into the remaining cavity. How local regional therapy for treatments of tumors, current ever, this method requires Surgical removal of the tumor, methods include transcatheter arterial chemoembolization which is not always feasible. (TACE), brachytherapy, and peritumor/intralesional injec 25 Peritumor/intralesional injection is another method in the tion. Patients with malignancies which are inoperable or art for administering a chemotherapeutic drug to a tumor. unsuitable for Surgery often have a poor prognosis, and Numerous examples exist in the art wherein a chemothera current palliative treatments have an associated morbidity peutic is administered intratumorally in a gel as a Sustained and mortality. release delivery System, Such as an epinephrine (epi) gel Primary and metastatic tumors may receive their blood (Miller et al., 1997; Burris et al., 1998; Kraus et al., 1998; supply predominantly or entirely from the arteries.
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