Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert
Patent
1994-08-02
1997-05-06
Page, Thurman K.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Implant or insert
424 111, 424425, A61K 31335
Patent
active
056268629
ABSTRACT:
A method and devices for localized delivery of a chemotherapeutic agent to solid tumors, wherein the agent does not cross the blood-brain barrier and is characterized by poor bioavailability and/or short half-lives in vivo, are described. The devices consist of reservoirs which release drug over an extended time period while at the same time preserving the bioactivity and bioavailability of the agent. In the most preferred embodiment, the device consists of biodegradable polymeric matrixes, although reservoirs can also be formulated from non-biodegradable polymers or reservoirs connected to implanted infusion pumps. The devices are implanted within or immediately adjacent the tumors to be treated or the site where they have been surgically removed. The examples demonstrate the efficacy of paclitaxel and camptothecin delivered in polymeric implants prepared by compression molding of biodegradable and non-biodegradable polymers, respectively. The results are highly statistically significant.
REFERENCES:
patent: 4757128 (1988-07-01), Domb et al.
patent: 4789724 (1988-12-01), Domb et al.
patent: 4857311 (1989-08-01), Domb et al.
patent: 4867978 (1989-09-01), Gold
patent: 4888176 (1989-12-01), Langer et al.
patent: 4943579 (1990-07-01), Vishnuvajjala et al.
patent: 5064823 (1991-11-01), Lee et al.
patent: 5145684 (1992-09-01), Liversidge et al.
patent: 5225404 (1993-07-01), Giovannella et al.
patent: 5362831 (1994-11-01), Mongelli et al.
patent: 5380751 (1995-01-01), Chen et al.
patent: 5395850 (1995-03-01), Roth
Walter et al., Chem. Abs. 120(22), 280088 (May 30, 1994).
Kaetsu et al.,Chem. Abs. 108(22) 192636 (May 30, 1988).
Straw et al., Chem. Abs. 121(20), 238234 (Nov. 14, 1994).
Auerbach et al., Chem. Abs. 121(1), 159 (Jul. 4, 1994).
Alkan-Onyuksel, Hayat, et al., "A Mixed Micellar Formulation Suitable for the Parenteral Administration of Taxol," Pharm. Res. 11(2):206-212 (1994).
Beckman, G., et al., "G-6-PD and PGM Phenotypes of 16 Continuous Human Tumor Cell Lines," Hum. Hered. 21:238-241 (1971).
Brem, Henry, et al., "Polymers as Controlled Drug Delivery Devices for the Treatment of Malignant Brain Tumors," Eur. J. Pharm. Biopharm. 39(1):2-7 (1993).
Brem, Henry, et al., "Interstitial chemotherapy with drug polymer implants for the treatment of recurrent gliomas," J. Neurosurg. 74:441-446 (1991).
Brem, Henry, et al., "Intraoperative Chemotherapy using biodegradable polymers: Safety and Effectiveness for Recurrent Glioma Evaluated by a Prospective, Multi-Institutional Placebo-Controlled Clinical Trail," Proc. Amer. Soc. Clin. Oncology May 17, 1994.
Bullard, Dennis E., et al., "Growth and Chemotherapeutic Response in Athymic Mice of Tumors Arising from Human Glioma-derived Cell Lines," J. Neuropathol. Exp. Neurol. 40:410-427 (1981).
Domb, A.J. and R. Langer, "Polyanhydrides. I. Preparation of High Molecular Weight Polyanhydrides," J. Polym. Sci. 25:3373-3386 (1987).
Domb, et al., "In Vitro Release Kinetics Studies," Polym. Prepr. 32(2):219-220 (1991).
Gottlieb, Jeffrey A., and James K. Luce, "Treatment of Malignant Melanoma With Camptothecin (NSC-100880)," Cancer Chemother. Rep. 56(1):103-105 (1972).
Gottlieb, Jeffrey A., et al., "Preliminary Pharmacologic and Clinical Evaluation of Camptothecin Sodium (NSC-100880)," Cancer Chemother. Rep. 54(6):461-470 (1970).
Grossman, Stuart, et al., "The intracerebral distribution of BCNU delivered by surgically implanted biodegradable polymers," J. Neurosurg. 76:640-647 (1992).
Hanauske, Axel-R., et al., "Effects of Taxotere and taxol on in vitro colony formation of freshly explanted human tumor cells," Anticancer Drugs 3:121-124 (1992).
Harrison's Principles of Internal Medicine 431-446, E. Braunwald et al., ed., McGraw-Hill Book Co. (1987).
Horwitz, S.B., et al., "Taxol: Mechanisms of Action and Resistance," Ann. NY Acad. Sci. 466:733-744 (1986).
Jacobsen, P.F., et al., "Establishment of a Human Medulloblastoma Cell Line and Its Heterotransplantation into Nude Mice," J. Neuropathol. Exp. Neurol. 44:472-485 (1985).
Jampel, Henry D., and Paroo Koya, "In Vitro Release of Hydrophobic Drugs From Polyanhydride Disks," Opthalmic Surg. 22,676-680 (1991).
Klecker, R.W., et al., "Distribution and metabolism of .sup.3 H-taxol in the rat," Proc. Am. Assoc. Cancer Res. 43:380 (1993).
Langer, Robert and Judah Folkman, "Polymers for the sustained release of proteins and other macromolecules," Nature (London) 263:797-799 (1976).
Langer, Robert, et al., "Biocompatibility of polymeric delivery systems for macromolecules," J. Biomed. Mater. Res. 15:267-277 (1981).
Leong, K.W., et al., "Bioerodible polyanhydrides as drug-carrier matrices. I: Characterization, degradation, and release characteristics," J. Med. Biomed. Mater. Res. 19:941 (1985).
Leong, K.W., et al. "Bioerodible polyanhydrides as drug-carrier matrices. II. Biocompatibility and chemical reactivity," J. Med. Biomed. Mater. Res. 20:51 (1986).
Moertel, Charles G., et al., "Phase II Study of Camptothecin (NSC-100880) in the Treatment of Advanced Gastrointestinal Cancer," Cancer Chemother. Rep. 56(1):95-101 (1972).
Muggia, Franco M., et al., "Phase I Clinical Trial Weekly and Daily Treatment with Camptothecin (NSC-100880): Correlation with Preclinical Studies," Cancer Chemother. Rep. 56(4):515-521 (1972).
Rhine, William D., et al., "Polymers for Sustained Macromolecule Release: Procedures to Fabricate Reproducible Delivery Systems and Control Release Kinetics," J. Pharm. Sci. 69:265-270 (1980).
Ringel, Israel, and Susan Band Horwitz, "Taxol is Converted to 7-Epitaxol, a Biologically Active Isomer, in Cell Culture Medium," J. Pharmacol. Exp. Ther. 242:692-698 (1987).
Rosen, H.B., et al., "Bioerodible polyanhydrides for controlled drug delivery," Biomaterials 4:131 (1983).
Rosenblum, Mark L., et al., "Development of a Clonogenic Cell Assay for Human Brain Tumors," Cancer 41:2305-2314 (1978).
Roth, B., et al., "Taxol (NSC 125973) in Advanced, Hormone-Refractory Prostrate Cancer: An Ecog Phase II Trail," Pr. Annu. Meet. Am. Soc. Clin. Oncol. 11:A598 (1992).
Rowinsky, Eric K., et al., "Microtubule Chanes and Cytotoxicity in Leukemic Cell Lines Treated with Taxol," Cancer Res. 48:4093-4100 (1988).
Rowinsky, Eric K., et al., "Phase I and Pharmacodynamic Study of Taxol in Refractory Acute Leukemias," Cancer Res. 49:4640-4647 (1989).
Rowinsky, Eric K., et al., "Taxol: A Novel Investigational Antimicrotubule Agent," J. Natl. Cancer Inst. 82:1247-1259 (1990).
Roytta, Matias, et al., "Morphological Studies on the Effect of Taxol on Cultured Human Prostatic Cancer Cells," Prostate 11:95-106 (1987).
Salcman, Michael, et al., "In Vitro Response of Human Glioblastoma and Canine Glioma Cells to Hyperthermia, Radiation, and Chemotherapy," Neurosurgery 29:526-531 (1991).
Sarosy, Gisele and Eddie Reed, "Taxol Dose Intensification and Its Clinical Implications," J. Nat. Med. Assoc. 85(6):427-431 (1993).
Slichenmyer, William J., et al., "New Natural Products in Cancer Chemotherapy," J. Clin. Pharmacol. 30:770-788 (1990).
Tamargo, Rafael J., et al. "Interstitial Chemotherapy of the 9L Gliosarcoma: Controlled Release Polymers for Drug Delivery in the Brain," Cancer Res. 53:329-333 (1993).
Tamita, T., "Interstitial chemotherapy for brain tumors: review" J. Neuro-Oncology 10:57-74 (1991).
Venditti, John M., and Betty J. Abbott, "Studies on Oncolytic Agents from Natural Sources, Correlations of Activity Against Animal Tumors and Clinical Effectiveness," Lloydia 30:332-348 (1967).
Brem Henry
Domb Abraham J.
Langer Robert S.
Howard Sharon
Massachusetts Institute of Technology
Page Thurman K.
The Johns Hopkins University
LandOfFree
Controlled local delivery of chemotherapeutic agents for treatin does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Controlled local delivery of chemotherapeutic agents for treatin, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Controlled local delivery of chemotherapeutic agents for treatin will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2130564