A New Cancer Treatment

The Syracuse Cancer Research Institute is involved in research into a totally new approach to cancer treatment. Results of this research have excited the interest of scientists and clinicians everywhere and are currently generating expanded experimentation both in this country and abroad.

The approach to this treatment of cancer taken by the Institute has been concerned with interruption of the prime cause of death in cancer rather than the prime cause of cancer itself. This prime cause of death in cancer is the weight loss and bodily debilitation seen characteristically in advancing disease. This is known medically as cachexia. It was reasoned that if cancer cachexia could be interrupted, the disease itself might be controlled (much as the disease of diabetes is controlled by the daily injection of insulin).

Such an approach holds the potential of not only reversing the devastating symptoms of cancer but—insofar as cancer cachexia and cancer growth are interrelated—reversing cancer growth as well.

Over three decades of research at the Institute and other laboratories and medical centers have gone into the validation of this new approach.


Early Progress

The Syracuse Cancer Research Institute began operations in 1966, founded by its director, Dr. Joseph Gold. At the time cancer cachexia was only a descriptive term, its causes entirely unknown. Research done by Dr. Gold indicated the condition to be largely the result of cancer’s ability to “recycle its wastes” at the energy expense of the body—and thus impose a severe energy drain on the body, eventually resulting in cachexia.

Specifically, it was pointed out that cancer uses glucose (sugar) as its fuel but only incompletely metabolizes (combusts) it. The cancer’s waste product—lactic acid—together with the breakdown products of other tissues of the body, spilling into the blood as a result of the cancer’s metabolism, are taken up by the liver and kidney (normal, non-cancerous tissues) and much energy is expended from these normal “host” tissues to build these waste and breakdown products back up to glucose.

The new glucose formed may then be re-presented to the cancer cell for fuel and the cycle will be repeated. The net result is a loss of energy from normal body energy “pools.” As the cancer grows, its production of lactic acid and other chemical intermediates increases, imposing on the body a condition in which the normal body energy “pools” become more and more depleted. Eventually the body reaches a point where dietary energy intake can no longer keep up with these energy losses and rapid weight loss and debilitation supervene. This is the onset of cachexia.

Dr. Gold theorized by interrupting this process of “host energy loss”—blocking the body’s chemical machinery which converts lactic acid and other breakdown products to glucose in normal tissues—cancer cachexia could be averted. In this regard subsequent experimentation at the Institute found that an entire new class of “gluconeogenic blocking agents” could bring about such “interruption.” One of these—the chemical hydrazine sulfate—was especially able to disrupt cancer’s energy “cycle” and thereby arrest and reverse cachexia.

In 1973 hydrazine sulfate began early clinical studies in human cancer patients. By 1975 it was clear that this drug had a stabilizing effect on patients with very advanced cancers. Its administration resulted in significant bodily and anticancer improvements. The chemical was also found to enhance the effects of other anticancer drugs and treatments in all cases tested.

Collaborative studies with other laboratories, universities and medical centers likewise gave support to the Institute’s early findings, enlarging the scope of application of this new approach to cancer treatment. Such results received wide exposure in the medical journals.


Growth

In 1977 the Institute completed a major expansion program, more than doubling in size. Laboratory facilities and resources increased more than four-fold, research programs escalated. Intensified anticancer testing of many agents took place; much experimental progress was made with the drug hydrazine sulfate, contributing to the groundwork of subsequent double-blind human trials.


Progress

The Institute’s progress in the last three decades devolves about the development and clinical testing of the effectiveness and safety of its drug hydrazine sulfate in our pharmaceutical arsenal against cancer.

In 1975 Russian scientists, under the Joint U.S.-U.S.S.R. Health Agreement of 1972, undertook controlled clinical trials of hydrazine sulfate, which showed marked improvement in late-stage—what they called “factually terminal”—cancer patients with different types of cancer. Increased appetite with weight stabilization and weight gain, improved performance status, decreased pain, diminished weakness, normalization of abnormal laboratory indices, tumor stabilization, tumor regression and an absence of important clinical side effects were reported.

Commencing in 1980 under grant sponsorship from the American Cancer Society and the National Institutes of Health, prospectively-randomized, placebo-controlled, double-blind clinical studies at Harbor-UCLA Medical Center in Los Angeles demonstrated hydrazine sulfate to improve glucose tolerance and reduce glucose turnover (energy-wasting), increase caloric intake and the efficacy of caloric intake, increase or stabilize weight, promote serum albumin maintenance (a prognostic marker of survival in some cancer patients) and induce statistically significant survival increase in patients with lung cancer. Again, no important clinical side effects were reported.

Seventeen years of controlled Russian studies and ten years of Harbor-UCLA randomized clinical trials—published in distinguished American peer-reviewed cancer and scientific journals, as well as respected journals elsewhere—together showed that of every million late-stage, refractory (no longer responsive to usual therapy) cancer patients treated with hydrazine sulfate, more than half a million would obtain measurable symptomatic improvement, 400,000 would demonstrate a halt or regression in tumor growth, and some would go on to long-term (greater than 10 years) survival. The American (Harbor-UCLA) studies characterized hydrazine sulfate as representing a “fundamentally new direction in cancer treatment.”

To date all controlled clinical trials, performed in accordance with internationally accepted scientific principles of study conduct—without exception—have indicated the efficacy and safety of hydrazine sulfate, whether used as a single agent or in conjunction with chemotherapy or radiation therapy.

The only contrary results to the Russian and Harbor-UCLA studies have been three trials sponsored by the National Cancer Institute (NCI), commending in 1990 and ending in 1992. However, these trials were compromised by the use of incompatible agents (medications)—tranquilizers, sleeping pills, alcohol—with the test drug, hydrazine sulfate.

The use of incompatible medications with a test drug is virtually unknown in human biomedical testing, since it can result in the grave illness—or death—of a patient, can cause a negative drug study and is in clear violation of multiple warnings against such use in the medical literature—and in violation of the Helsinki Declaration.

The Helsinki Declaration is a multinational ratification of principles governing human biomedical research studies, to which the United States is a principle signatory, which was put in place to guarantee that no harmful procedures be used in patients undergoing experimental medical treatment. Principle 1 of the Helsinki Declaration states: “Biomedical research involving human subjects must conform to generally accepted scientific principles and be based on a thorough knowledge of the medical literature.” Perhaps most important of generally accepted scientific principles in the conduct of human biomedical research is that no incompatible agents (medications) be used in a drug trial. This document lies at the very heart of internationally accepted standards for biomedical research and is at the very core of all clinical trials and informed consent. As such, the Helsinki Declaration represents the international “law of the land” and requires all human biomedical research to conform to its stated principles.

The Russian and Harbor-UCLA studies of hydrazine sulfate were in full conformity with the Helsinki Declaration.

The NCI-sponsored trials of hydrazine sulfate were out of compliance with the Helsinki Declaration. None of the published NCI-sponsored studies referenced this document.

Despite the NCI-sponsored studies being out of compliance with the Helsinki Declaration and their failure to even reference this document in its protocols or published studies, the NCI is the largest and most influential cancer agency in the world—and its “credentials” are most respected among many in the world medical community. Consequently, NCI’s differing results from the Russian and Harbor-UCLA trials were sufficient to envelop hydrazine sulfate in ongoing “controversy.”

The Syracuse Cancer Research Institute has devoted much energy and many resources to counteracting the controversy that has arisen as a result of the NCI-sponsored studies—and continues to work to make this inexpensive medication available to doctors and patients throughout the world. At present this medication is available by doctor’s prescription in the United States and elsewhere.