Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Nitrogen containing other than solely as a nitrogen in an...
Reexamination Certificate
2001-10-17
2004-02-10
Goldberg, Jerome D. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Nitrogen containing other than solely as a nitrogen in an...
Reexamination Certificate
active
06689815
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention pertains to the treatment of benign and malignant tumors by injections. Dinitrochlorobenzene (or DNCB) and other dinitrohalogenated compounds are chemicals which, when applied to the skin, act as a haptens with associated skin proteins and elicit immunological responses in individuals with intact immune systems.
DNCB has, in the past, been topically applied to the surface of the skin to areas of actinic damage, or to the surface of some human tumors, primarily superficial skin tumors such as basal cell carcinomas. The current application describes the use of the chemical as an agent for injection, and describes techniques and dosages that optimize its use as an anti-cancer agent against more aggressive malignancies.
Human tumors, benign and malignant, share most of their antigens with the antigens of normal tissues. The antigenicity of a human tumor in its human host is therefore generally low because of the relatively weak antigenic differences between tumors and normal tissues. As a result, tumors frequently become progressive, to the point where the advancing nature of the malignancy threatens the life of the affected individual.
Methodologies which increase the antigenicity of the offending tumor cells, can potentially render the cells susceptible to immunologic destruction by the host. Additionally, a tumor destructive technique that damages or weakens tumor cells may render such cells susceptible to elimination by the host.
Years ago I found that on putting certain chemicals on or into the skin that some immunological changes and other effects were seen. I did not describe how the injections were prepared, or what an ideal injection would contain. I did not describe nor did I know at that time the locations in the body that were uniquely suitable for such an approach. I did not describe the range of conditions for which the approach is applicable. I did not describe the special methodology of the injection process. Described in this application for the first time is the ideal dosing schedule. Effective methodology is described herein for treating sites not previously successfully treated. The combination of DNCB or dinitrofluorobenzene (DNFB) with other products and delivery systems is described, as well.
Malignant melanoma is a cancer that spreads locally through “skip metastases,” or nests of tumor in the skin separated by histologically normal tissue from the site of the primary or original malignancy. As these nests of tumor cells enlarge to a noticeable size they release other cells that form another series of tumor nodules which again may be separated by intervening normal tissues from the originating nodules of malignancy. During such a progression it becomes rapidly apparent that surgical removals are inadequate to control the disease because of microscopic tumor deposits present at a considerable distance from the visible tumor recurrences. The tumors are notoriously resistant to chemotherapy or radiation therapy, the two other mainstays of cancer treatment, besides surgery. It is therefore of particular significance for this subset of patients that the techniques described herein are capable of delaying tumor progression, and in some cases by providing long term survival free of malignancy in a setting where the likelihood of the patient succumbing to the malignancy is otherwise essentially 100%.
BRIEF SUMMARY OF THE INVENTION
There are certain conditions in human cancer care where there has previously been no treatment capable of producing long term cancer control. Malignant melanoma, for example spreads as widely as any human cancer. As it continues to spread locally in the surrounding skin, it becomes unstoppable by repeated surgical excisions. The prognosis for survival at this point drops essentially to zero percent. If the recurrences are in an extremity, such as the leg, the option exists of using heated chemotherapy pumped into the blood vessels of the leg. The procedure is labor intensive, costly and difficult to repeat when the cancer nodules begin to recur. If the melanoma recurs and the nodules of recurrences are on the scalp, there is currently no effective treatment available to patients whose nodules continue to recur. In the case of recurrent scalp melanoma, systemic chemotherapy cannot be delivered into blood vessels running to the scalp, since the brain would be damaged as a side effect. Using methods to be described, DNCB and perhaps other dinitrohalogenated benzene compounds, can arrest and reverse such growth in some patients, on a long term basis, in cases where no other treatment option can control the disease. Details of the preparation method are described. An optimal immunization or preutilization schedule is described. Optimal dosage and techniques of injection are described. Methods of delivery of DNCB and combinations with other techniques are described. Comparison with the prior art is discussed, together with mention of improvements in methodology.
REFERENCES:
patent: 6350451 (2002-02-01), Horn et al.
Cohen et al.; Intralesional Treatment of Recurrent Metastatic Cutaneous Malignant Melanoma; Cancer 41:2456-2463, 1978.*
Lukacs et al.; Immunosurgical approach to the treatment of malignant melanoma using 2,4-dinitrochlorobenzene (DNCB); Neoplasma, 31, 4, 1984, pp 437-445.*
Budzanowaska et al.; An attempt at topical DNCB immunomodulation in advanced malignant melanoma; Tumori, 74: 519-522, 1988.
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