YOU ARE NOW CONNECTED TO THE TOXLINE (1981 FORWARD, NON-ROYALTY) FILE. ==HYDRAZINE SULFATE AND CANCERS== 3 AUTHOR Filov VA AUTHOR Gershanovich ML AUTHOR Danova LA AUTHOR Ivin BA TITLE Experience of the treatment with Sehydrin (Hydrazine Sulfate, HS) in the advanced cancer patients. SOURCE Invest New Drugs; VOL 13, ISS 1, 1995, P89-97 ABSTRACT The results of Sehydrin (Hydrazine Sulfate, HS) treatment of 740 patients with the advanced, recurrent or metastatic solid tumours of various localizations or malignant lymphomas, for whom all the methods of specific treatment (surgery, radiation, chemotherapy) had been exhausted are presented in this work. The objective response, symptomatic therapeutic effects and toxicity were estimated. Clinically significant objective responses were registered in patients with the soft tissue sarcomas, including neuroblastomas, and paradoxically--in such semimalignant tumours as desmoids. Although the objective response in patients with the lung cancer (90%--non-small cell) was only 4%, stabilization of long duration was registered in 22% of cases connected with the impressive relief of heavy common symptoms in 38.5% of the treated patients. Such a subjective response was established in 46.6% of all the 740 cases. The drug given per os was well tolerated by patients in primary and subsequent courses and did not induce myelosuppression or other significant side effects. On the basis of observations available, Sehydrin may be assessed as an alternative drug for the treatment and symptomatic therapy of patients with some advanced solid tumours and malignant lymphomas at a disease stage when the other methods of treatment can not be used. A possible mechanism of antitumour and symptomatic action is being discussed. 4 AUTHOR Loprinzi CL AUTHOR Goldberg RM AUTHOR Su JQ AUTHOR Mailliard JA AUTHOR Kuross SA AUTHOR Maksymiuk AW AUTHOR Kugler JW AUTHOR Jett JR AUTHOR Ghosh C AUTHOR Pfeifle DM AUTHOR et al TITLE Placebo-controlled trial of hydrazine sulfate in patients with newly diagnosed non-small-cell lung cancer [see comments] SOURCE J Clin Oncol; VOL 12, ISS 6, 1994, P1126-9 ABSTRACT PURPOSE: Hydrazine sulfate, an agent that appears to inhibit gluconeogenesis, has been studied in cancer patients for approximately 20 years. There was a recent resurgence of interest in this drug when subset analysis of a small placebo-controlled, double-blind, clinical trial reported improved survival among non-small-cell lung cancer patients with a good performance status who were randomized to receive this drug along with standard chemotherapy. PATIENTS AND METHODS: Patients on this trial had newly diagnosed, unresectable non-small-cell lung cancer and were treated with cisplatin and etoposide. In addition, they were randomized to receive hydrazine sulfate or placebo in a double-blind manner. RESULTS: A total of 243 patients were randomized. Response rates were similar in the two treatment arms. There were trends for worse time to progression and survival in the hydrazine sulfate arm. No significant differences were noted in the two study arms with regard to toxicity or quality of life (QL). CONCLUSION: This trial failed to demonstrate any benefit for patients who received hydrazine sulfate. 5 AUTHOR Loprinzi CL AUTHOR Kuross SA AUTHOR O'Fallon JR AUTHOR Gesme DH Jr AUTHOR Gerstner JB AUTHOR Rospond RM AUTHOR Cobau CD AUTHOR Goldberg RM TITLE Randomized placebo-controlled evaluation of hydrazine sulfate in patients with advanced colorectal cancer [see comments] SOURCE J Clin Oncol; VOL 12, ISS 6, 1994, P1121-5 ABSTRACT PURPOSE: Hydrazine sulfate is a controversial agent that was originally studied in cancer patients approximately 20 years ago. Based on a series of recent trials that suggested that this drug might have utility in cancer patients, we conducted this study. PATIENTS AND METHODS: Patients with metastatic colorectal cancer were randomized to receive hydrazine sulfate or placebo in a double-blinded manner. Protocol patients did not concurrently receive any other systemic antineoplastic treatment. RESULTS: There were 127 assessable patients entered onto this clinical trial. Data from the study showed trends both for poorer survival and for poorer quality of life (QL) in the hydrazine group. There were no significant differences in the two study arms with regard to anorexia or weight loss. CONCLUSION: This trial failed to demonstrate any benefit for hydrazine sulfate. 10 AUTHOR Chlebowski RT AUTHOR Bulcavage L AUTHOR Grosvenor M AUTHOR Oktay E AUTHOR Block JB AUTHOR Chlebowski JS AUTHOR Ali I AUTHOR Elashoff R TITLE Hydrazine sulfate influence on nutritional status and survival in non-small-cell lung cancer. SOURCE J Clin Oncol; VOL 8, ISS 1, 1990, P9-15 ABSTRACT This randomized, prospective, placebo-controlled clinical trial compares the influence on nutritional status and survival of hydrazine sulfate with placebo addition to cisplatin-containing combination chemotherapy in patients with unresectable non-small-cell lung cancer (NSCLC). The trial consisted of 65 patients with advanced, unresectable NSCLC who had had no prior chemotherapy, were at least partially ambulatory (Eastern Cooperative Oncology Group [ECOG] performance status [PS] level 0-2), and who had adequate hematologic, renal, and hepatic function. All patients received the same defined combination chemotherapy (cisplatin, vinblastine, and bleomycin) and the same defined dietary counseling with the addition of either three times daily oral hydrazine sulfate (60 mg) or placebo capsules. Hydrazine sulfate compared with placebo addition to chemotherapy resulted in significantly greater caloric intake and albumin maintenance (P less than .05). Considering all patients, survival was greater for the hydrazine sulfate compared with placebo group (median survival, 292 v 187 days), but the difference did not achieve statistical significance. In favorable PS patients (PS 0-1), survival was significantly prolonged (median survival, 328 days v 209 days; P less than .05) for hydrazine sulfate compared with placebo addition. In a multifactor analysis, PS, weight loss, and liver involvement were the final variables. Objective response frequency and toxicity were comparable on both arms. Hydrazine sulfate may favorably influence nutritional status and clinical outcome of patients with NSCLC. Further definitive studies of hydrazine sulfate addition to therapeutic regimens in NSCLC are warranted. 11 AUTHOR Filov VA AUTHOR Danova LA AUTHOR Gershanovich ML AUTHOR Ivin BA AUTHOR Dement'eva NP AUTHOR Breivis PV AUTHOR Ragaishene VP AUTHOR Kas'ianenko IV AUTHOR Lisitsa AM AUTHOR Mindlin SS AUTHOR et al TITLE [The results of a clinical study of the preparation hydrazine sulfate] SOURCE Vopr Onkol; VOL 36, ISS 6, 1990, P721-6 ABSTRACT The paper discusses results of a cooperative study of effectiveness of hydrazine sulfate therapy in 740 patients with primary advanced, recurrent and metastatic solid tumors and malignant lymphomas who had failed all other treatment modalities. Both objective response and symptomatic effect were assessed. Objective response was observed in neuroblastoma, recurrent desmoid, Hodgkin's disease, lung cancer, fibrosarcoma and other tumors. Since hydrazine sulfate provided relief of a wide spectrum of cancer symptoms, it may be recommended for patients with end-stage cancer. 18 AUTHOR Chlebowski RT AUTHOR Bulcavage L AUTHOR Grosvenor M AUTHOR Tsunokai R AUTHOR Block JB AUTHOR Heber D AUTHOR Scrooc M AUTHOR Chlebowski JS AUTHOR Chi J AUTHOR Oktay E AUTHOR et al TITLE Hydrazine sulfate in cancer patients with weight loss. A placebo-controlled clinical experience. SOURCE Cancer; VOL 59, ISS 3, 1987, P406-10 ABSTRACT Hydrazine sulfate was evaluated using 24-hour dietary recalls and body weight determinations before and after 30 days of either placebo or hydrazine (60 mg, 3 times/d) oral administration in 101 heavily pretreated cancer patients with weight loss. After 1 month, 83% of hydrazine and only 53% of placebo patients completing repeat evaluation maintained or increased their weight (P less than 0.05). In addition, appetite improvement was more frequent in the hydrazine group (63% versus 25%, P less than 0.05). Although caloric intake was only slightly greater in hydrazine-treated patients, an increased caloric intake was more commonly associated with weight gain in patients receiving hydrazine compared with those receiving placebo (81% versus 53%, respectively). Hydrazine toxicity was mild, with 71% of patients reporting no toxic effects. Hydrazine sulfate circulatory levels were obtained from a subset of 14 patients who completed 30 days of treatment, with a single sample obtained in the morning at least 9 hours after the last dose. Mean maintenance hydrazine sulfate levels, determined using a spectrofluorometric assay, ranged from 0 to 89 ng/ml (mean 45 +/- 16 ng/ml). These data, which demonstrate an association between 1 month of hydrazine sulfate administration and body weight maintenance in patients with cancer, suggest future clinical trials of hydrazine sulfate are indicated to definitively assess its long-term impact on important clinical outcome parameters in defined cancer populations.