Claims
- 1. A method for prolonging patient survival in an early-stage human cancer patient which comprises internally administering to said human hydrazine sulfate in an effective dosage sufficient in amount and for a duration of from fourteen weeks to four years to prolong patient survival without treating a cancerous tumor per se.
- 2. The method of claim 1 wherein the hydrazine sulfate is administered orally in dosage form.
- 3. The method of claim 2 wherein the dosage form is a gelatin capsule or tablet.
- 4. The method of claim 1 wherein the hydrazine sulfate is administered parenterally.
- 5. The method of claim 1 wherein the dosage of hydrazine sulfate is 1 to 5 mg/kg of body weight daily.
- 6. The method of claim 1 wherein the hydrazine sulfate is administered in a daily regimen of one 60 milligram capsule for three days, then two 60 milligram capsules for the next three days, and three 60 milligram capsules each day thereafter for up to four years.
- 7. The method of claim 1 wherein the hydrazine sulfate is administered to patients weighing less than 100 pounds in a daily regimen of one 30 milligram capsule for three days, then two 30 milligram capsules for the next three days, then two or three 30 milligram capsules each day thereafter for up to four years.
BACKGROUND OF THE INVENTION
This application is a continuation-in-part of pending Ser. No. 201,083, filed June 1, 1988, now abandoned, which is a continuation of Ser. No. 032,051, filed Mar. 27, 1987, now abandoned.
Many different types of chemical compounds have been used in the past to retard or inhibit various tumors in man. More than thirty compounds are approved for use in cancer therapy in various countries, but the achievement of therapeutic benefit has reached a plateau, and the search for antitumor agents continues in various directions.
In 1967, Weitzel and co-workers reported in the Zeitschrift fuer Physiologische Chemie, 348, 433-442 that hydrazine acetate and sulfate inhibit in vivo the growth of ascites carcinoma and sarcoma 180 in the mouse and Walker carcinosarcoma in the rat. It is well known that the results from lower animals cannot be extrapolated in humans. Indeed, the experience at the U.S. National Institutes of Health has been that more than 200 new chemotypes having anticancer activity in animals have failed to show clinically useful anticancer activity in humans, as shown in the following table (Table I was compiled from various reports of the U.S. National Cancer Institute):
In addition, hundreds of analogs of the new and old chemotypes have failed to show anticancer activity in man, in spite of good antitumor activity in animals. In contrast to the above, only about five new chemotype anticancer drugs have reached the market in the last 25 years. Hence, early reports that hydrazine sulfate had antitumor activity in animals did not serve to predict that it might have anticancer activity in humans.
Because of this poor predictability of animal models, the National Cancer Institute of the U.S. National Institutes of Health has now abandoned the mouse model after 25 years of unproductive trial and is instituting a new in vitro program for discovering new antitumor drugs (E. Eckholm, New York Times, Dec. 23, 1986, p. C1).
A total inventory of cancer drugs approved for sale in the United States is set forth in Table II, and it will be seen that most of these are analogs of other drugs. Table III shows that, with one exception, all of the recent New Drug Applications filed for anticancer drugs led to unapprovable ratings by the U.S. Food and Drug Administration. Table IV shows that the last new chemotype which succeeded in the clinic was discovered more than 20 years ago.
A review of the FDA's New Drug Evaluation - Statistical Report (March 1986) shows that no novel anticancer drug is pending approval at the FDA.
Table IV lists the anticancer drugs approved in the United States. The last non-hormonal anticancer agent to be approved in the U.S. was etoposide in 1983.
The following are the years of discovery of the major anticancer drugs on the U.S. market (arbitrarily assumed to be one year before the first publication):
Thus, there have been no new chemotype cytotoxic anticancer drugs discovered in the past twenty years. Consequently, there remains an unfulfilled need for additional cancer drugs for clinical use against tumors in humans.
Up the present time, it has been generally unrecognized that a specific anticachexia agent (by virtue of its ability to interrupt those specific thermodynamic metabolic processes leading to cancer cachexia) possesses antitumor potential, by virtue of a systematic thermodynamic interrelationship between tumor progression (tumor energy gain) and cancer cachexia (host energy loss); this has been taught in the scientific literature since 1974 (J. Gold, Cancer Cachexia and Gluconeogenesis, Ann. N.Y. Acad. Sci., 230, 103-110 (1974)). Thus, while it is true that any antitumor agent may have anticachexia potential, if curative, it is also true that a specific anticachexia agent may have potential for increased patient survival. However, it is not obvious, nor predictable, from the prior art that hydrazine sulfate would possess this potential.
In 1978, the present inventor was issued U.S. Pat. No. 4,110,437 for the treatment of cancer cachexia with hydrazine sulfate. Investigations were also undertaken to ascertain whether hydrazine sulfate could retard tumor growth in humans. However, these early studies were inadequate and failed to statistically demonstrate antitumor activity.
A group at Sloan-Kettering concluded after a trial that: "The clinical observations recorded in this report fail to support a role for hydrazine sulfate as an anticancer agent. We conclude that its clinical utilization is not warranted at present and do not plan further trials."(Ochoa et al., Cancer Chemotherapy Reports, Part 1, Vo. 59, No. 6, Nov./Dec. 1975; pp. 1151-1154).
In addition, a group at the University of Virginia repoted that: "Hydrazine sulfate as administered in this series failed to demonstrate any objective or subjective antitumor activity and no further trials are currently planned."(Lerner and Regelson, Cancer Treatment Reports, Vol. 60, No. 7, July 1976, pp. 959-966). Another later publication by Regelson et al. stated: "In conclusion, we feel that hydrazine sulfate as given in this study is an inactive compound."(Cancer Chemother. Pharmacol., 3, 121-124, 1979).
Thus, the prior art taught that hydrazine sulfate appeared to be inactive against primary tumor growth in man.
This invention is based on the discovery that hydrazine sulfate, when administered parenterally or orally in effective, non-toxic amounts to humans with tumors of the lung, prostate, breast, ovaries, thyroid, pancreas, lymph, cervix, gastrointestinal tract and other sites will significantly prolong survival of early-stage human cancer patients, while improving the patient's quality of life.
US Referenced Citations (1)
| Number |
Name |
Date |
Kind |
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4110437 |
Gold |
Aug 1978 |
|
Continuations (1)
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Number |
Date |
Country |
| Parent |
32051 |
Mar 1987 |
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Continuation in Parts (1)
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Number |
Date |
Country |
| Parent |
201083 |
Jun 1988 |
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Patent Grant
4867978
