Drug – bio-affecting and body treating compositions – Radionuclide or intended radionuclide containing; adjuvant... – Dissolving or eluting from solid or gel matrix
Utility Patent
1998-11-03
2001-01-02
Dees, Jose′ G. (Department: 1619)
Drug, bio-affecting and body treating compositions
Radionuclide or intended radionuclide containing; adjuvant...
Dissolving or eluting from solid or gel matrix
C424S001330, C424S001290, C424S001370, C424S001650, C424S001610, C600S003000, C600S004000
Utility Patent
active
06168777
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention is directed to methods for treating prostate tumors by use of radioactive compositions. Specifically, these methods entail the in vivo delivery of radioactive compositions which are delivered as a fluid to one or more sites in the prostate of a male mammal including the solid mass tumor(s) located on or in the prostate. Subsequent solidification of this composition in the prostate results in delivery of a controlled amount of radiation to the prostate.
In one embodiment, the fluidic radioactive compositions employed in the methods of this invention comprise a biocompatible polymer, a biocompatible solvent and a radioactive agent which provides therapeutic doses of radiation. In another embodiment, the fluidic radioactive compositions employed in the methods of this invention comprise a biocompatible prepolymer, a radioactive agent and optionally a biocompatible solvent which provides therapeutic doses of radiation to the prostate.
References
The following publications are cited in this application as superscript numbers:
1
Dunn, et al., U.S. Pat. No. 4,938,763 for “Biodegradable In-Situ Forming Implants and Methods of Producing Same”, issued Jul. 3, 1990
2
Kinugasa, et al., “Direct Thrombois of Aneurysms with Cellulose Acetate Polymer”,
J. Neurosurg
., 77:501-507 (1992)
3
“CANCER, Principles & Practice of Oncology”, 4th Ed., Volume 1
, “Cancer Treatment
”, pp. 545-548 (1993)
4
Greff, et al., U.S. Pat. No. 5,667,767, for “Novel Compositions for Use in Embolizing Blood Vessels”, issued Sep. 16, 1997
5
Greff, et al., U.S. Pat. No. 5,580,568 for “Cellulose Diacetate Compositions for Use in Embolizing Blood Vessels”, issued Dec. 3, 1996
6
Kinugasa, et al., “Early Treatment of Subarachnoid Hemorrhage After Preventing Rerupture of an Aneurysm”,
J. Neurosurg
., 83:34-41 (1995)
7
Kinugasa, et al., “Prophylactic Thrombosis to Prevent New Bleeding and to Delay Aneurysm Surgery”,
Neurosurg
., 36:661 (1995)
8
Taki, et al., “Selection and Combination of Various Endovascular Techniques in the Treatment of Giant Aneurysms”,
J Neurosurg
., 77:37-24 (1992)
9
Evans, et al., U.S. patent application Ser. No. 08/802,252 for “Novel Compositions for Use in Embolizing Blood Vessels”, filed Feb. 19, 1997
10
Castaneda-Zuniga, et al., Interventional Radiology, in Vascular Embolotherapy, Part 1, 1:9-32, Williams & Wilkins, Publishers (1992)
11
Rabinowitz, et al., U.S. Pat. No. 3,527,224 for “Method of Surgically Bonding Tissue Together”, issued Sep. 8, 1970
12
Hawkins, et al., U.S. Pat. No. 3,591,676 for “Surgical Adhesive Compositions”, issued Jul. 6, 1971
13
Nori, et al., Current Issues in Techniques of Prostate Brachytherapy, Seminars in Surgical Oncology, 13:444-453 (1997)
14
Anderson, et al., Spacing Nomograph for Interstitial Implants of 125-I Seeds, Med. Phys., 3:48-51 (1976)
All of the above publications are herein incorporated by reference in their entirety to the same extent as if each individual reference was specifically and individually indicated to be incorporated herein by reference in its entirety.
2. State of the Art
Adenocarcinoma of the prostate is the most common malignancy diagnosed among men in the United States. Current therapeutic regimens for treating prostate tumors include external radiation therapy, brachytherapy, surgery, radical prostatectomy, and the like as well as combinations of two or more of the above.
Brachytherapy, or the internal deposition of radioactive particles into the prostate, has superior potency preservation rates as compared to external beam radiation therapy or surgery. Brachytherapy is characterized as temporary (i.e., radioactive seeds are delivered, e.g., by a catheter to the prostate for a short period of time and then removed) or permanent (i.e., radioactive seeds are delivered to the prostate and not removed). Permanent brachytherapy typically involves needle injection of radioactive seeds into the prostate.
13
The radioactive seeds comprise a radioactive agent, e.g.,
192
iridium, typically dimensioned with a length of from 2-4 millimeters. Such seeds are typically injected via a 17 or 18 gage needle into the prostate via stereotactic imaging with the aid of ultrasound or fluoroscopic guidance and the protocol typically entails the delivery of up to 20 or more seeds. Stereotactic imaging allows the clinician to accurately deliver these seeds to the desired location in the prostate and the radiation emitted from these seeds effectively causes necrosis of at least a portion of the tumor over time.
One drawback with such permanent brachytherapy is that the total dose of radiation delivered into the prostate is governed by the size and number of the seeds delivered as well as the radioactive content of the seeds. Typically, the size and radioactive content of the seeds employed is dictated by the commercial availability of the seeds and, accordingly, the clinician typically has control only over the number of seeds delivered as a means to control the total dose of radiation. In certain cases where delivery of a high local dose of radiation to a particular portion of the prostate is desired by the clinician, multiple seed injections in this area will be required.
It is clear, however, that allowing the clinician better control of the radiation dose delivered to the prostate will simplify the protocol and provide greater flexibility in the treatment regimen selected by the clinician.
SUMMARY OF THE INVENTION
This invention is directed to methods for treating prostate tumors by use of radioactive compositions. These compositions are delivered to the prostate as a fluid composition which solidifies in vivo to form a solid, coherent radioactive mass. The methods of this invention permit the clinician to control the total amount of radiation delivered to the prostate during each injection merely by adjusting the quantity of fluid delivered and the concentration of radiation per given volume of fluid. In any event, sufficient amounts of radiation are delivered to the prostate to effect necrosis of at least part of the solid mass tumors located thereon or therein.
Accordingly, in one of its method aspects, this invention is directed to a method for causing necrosis to a portion of a solid mass prostate tumor which method comprises:
(a) selecting a fluidic composition comprising a biocompatible polymer, a biocompatible solvent and a water insoluble radioisotope; and
(b) injecting a sufficient amount of said composition into the prostate of a male mammal under conditions wherein a solid mass is formed
wherein the radioisotope is employed in an amount effective to cause necrosis of at least a portion of said tumor.
Preferably the radioactive fluid composition employed in this aspect of the methods of this invention comprises:
(a) a biocompatible polymer;
(b) a biocompatible solvent; and
(c) from about 0. 1 to about 35 weight percent of a water insoluble radioisotope having a radioactive content of from about 0.50 microcurie to about 200 millicuries.
The biocompatible polymer employed in these compositions and methods can be either a biodegradable polymer or a non-biodegradable polymer but is, preferably, a non-biodegradable polymer.
In another aspect of this invention, the biocompatible polymer can be replaced with a biocompatible prepolymer and, when so used, the presence of the biocompatible solvent becomes optional. In this embodiment, this invention is directed to a method comprising:
(a) selecting a fluidic composition comprising a biocompatible prepolymer, a water insoluble radioisotope and optionally a biocompatible solvent; and
(b) injecting a sufficient amount of said composition into the prostate of a male mammal under conditions wherein a solid mass is formed
wherein the radioisotope is employed in an amount effective to cause necrosis of at least a portion of said tumor.
Preferably the radioactive fluid composition employed in this aspect of the methods of this invention comprises:
(a) a biocompatible prepolymer;
(b) an optional biocompatible solvent; and
(c) from
Greff Richard J.
Wallace George
Burns Doane , Swecker, Mathis LLP
Dees Jose′ G.
Micro Therapeutics Inc.
Sharareh Shahnam
LandOfFree
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