Filov et al. performed a study in 1976 on 95 patients with advanced cancer who were treated with hydrazine sulfate after all other therapies were exhausted. No complete responses were found after 1 to 5 months of treatment but there were 3 partial responses (greater than 50% reduction in tumor size for at least 4 weeks or longer). Reductions ofless than 50% and stabilized disease (no tumor growth for at least 1′h to 2 months) were seen in 16 of 20 patients (80%).
The same investigators published a continuation of their 1976 study in 1981. This study had 225 patients with advanced cancer that had failed all previous therapies. The 95 patients from the 1976 study were included in the 225 patients in this study. Again, no complete responses were noted, but there were 4 partial responses after 1 to 6 months of treatment. Stabilized disease was noted in 95 of 225 patients (42%). Subjective improvements in appetite, weight gain, and mental outlook were reported in 147 of 225 patients (65%).
A prospective, randomized, double-blind, placebo controlled study was performed in 1984 on 38 patients with advanced cancer and weight loss to evaluate the effect of hydrazine sulfate (HS) on carbohydrate metabolism in cancer-related cachexia. All patients had 3-day metabolic evaluations including glucose tolerance test, hormonal studies, and total glucose production by infusion. After 30 days of treatment with either 60 mg HS three times a day or placebo, a repeat evaluation was performed. There were frequent reports of abnormal glucose tolerance tests and impaired glucose production on the initial exam. After 30 days of treatment: there were significant imrovements III glucose tolerance comared to placebo (169 +/- 24 mg/dl initial HS vs. 128 +/- 12 mg/dl final HS; p < 0.05). No improvements in glucose tolerance were seen in patients taking placebo. In addition, the rate of total glucose production was significantly reduced after 30 days compared to placebo (2.46 mg/kg/min HS vs. 3.07 mg/kg/min placebo; P < 0.05). Minimal toxic effects were reported.
Chlebowski et al. performed a prospective, placebo-controlled trial in 1990 comparing the influence of hydrazine sulfate on nutritional status and survival in patients with unresectable non-small cell lung cancer (NSCLC). All 65 patients received the same chemotherapy regimen of cisplatin, vinblastine, and bleomycin. Patients were then randomized to receive 60mg HS 3 times daily or placebo. In comparison with patients taking placebo, patients taking hydrazine sulfate showed significantly higher caloric intake and greater albumin maintenance (P < 0.05). In addition, survival was significantly longer in the hydrazine sulfate group compared to placebo (P < 0.05), while toxicity was comparable in both groups.
Tayek et al. sought to identify the combined metabolic effects of 5-FU and hydrazine sulfate in a 1995 study of 22 patients with advanced colon cancer. The patients had baseline measurements of coounter-regulatory hormones, fasting hepatic glucose production (HGP), glucose tolerance test, plasma leucine appearance (LA), and leucine oxidation. Significant findmgs for the combined therapy include a reduction in fasting glucose levels ;8 +/- 2 mg/dl vs. 94 +/- 2 mg/dl; p< 0.025), and plasma leucine appeaance (63.3 +/- 3 mmol/kg/hrvs. 57.1 +/- 3.9 mmol/kg/hr; P < 0.025). Multiple regression analysis later revealed that plasma LA was directly related to length of survival time, while baseline HGP, CEA, and insulin concentration were inversely related to survival time.
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