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.

 

EFFICACY OF HYDRAZINE SULFATE IN THE TREATMENT OF CANCER

Joseph Gold
Syracuse Cancer Research Institute, Syracuse, N.Y.

April 2, 2013

This is the first official notice of the efficacy of hydrazine sulfate in the treatment of human cancer.

For years the Syracuse Cancer Research Institute has known of and publicized the efficacy and safety of hydrazine sulfate in the treatment of human cancer. Controlled clinical trials of this drug performed from 1976 through 1990 in accordance with internationally accepted standards (the Helsinki Declaration) demonstrated that for every million late-stage, unresponsive cancer patients treated with hydrazine sulfate, the drug developed by the SCRI, a half-million (50%) will respond with measurable symptomatic improvement, 400,000 (40%) will obtain tumor stabilization or regression (either no further tumor growth or tumor shrinkage), and some will go on to long term (>10 years) “complete response,” i.e., survival. These controlled clinical studies included ten years of Phase III randomized, placebo-controlled trials at Harbor-UCLA Cancer Center in Torrance, CA and 17 years of multicentric Phase II equivalent trials headquartered at the N. N. Petrov Research Institute of Oncology in St. Petersburg, Russia. These positive trials were all published in premier American peer-reviewed medical journals.

Only three controlled trials, all sponsored by the National Cancer Institute, have failed to show positive effects. However, all three trials were in violation of Principle 1 (the “generally accepted standards” rule) of the Helsinki Declaration by virtue of their use of incompatible agents (medications) with the test drug and therefore declared by this Declaration to have no scientific standing. Despite this, the NCI has consistently published the negative outcome of its sponsored trials, with the result that the use of this drug has become controversial.

No further controlled studies could be done. For this reason the SCRI felt it necessary to await further news of confirmation of drug effect before being justified in making a formal announcement to the public of drug efficacy.

Over the past 20 years the SCRI has acted as a central headquarters in receiving reports from thousands of doctors, veterinarians and individuals regarding their patients, loved ones and pets with cancer, treated with hydrazine sulfate alone. At this time we can disclose to the public that the results of all these single case reports seem to be identical to the combined controlled clinical studies of Harbor-UCLA and the N. N. Petrov Research Institute of Oncology quoted above: 50% measurable symptomatic improvement, 40% tumor stabilization or regression, 5%-10% long term “complete response,” i.e., survival. And these are in very advanced patients. Even better results have been reported in early or newly diagnosed patients.

Joseph Gold, M.D.