zinostatin and Anorexia

A phase II study of YM 881 (zinostatin stimalamer) to determine the response and safety was conducted in patients with hepatocellular carcinoma by injecting a suspension of the drug into the hepatic artery. Repeated doses of 4 to 6 mg of the drug were given every 4 weeks so that the tumor tissues were filled with the suspension. Of the 195 registered patients, 15 were ineligible for the study, 8 dropped out, and data were missing for 5. A total of 167 patients completed the study. Response was assessed in the 167 patients who completed the study. CR was found in one, PR in 59, MR in 25, NC in 67, and PD in 15, with a response rate of 35.9. The safety of the drug was assessed in 177, excluding ineligible patients and 3 who dropped out because of the concurrent use of other drugs. Adverse reactions were found in 93.2% of the patients, and abnormal values in clinical laboratory tests in 60.5%. Major unwanted symptoms included fever, nausea, vomiting, and anorexia. Major abnormal changes in laboratory tests were elevated total bilirubin and LDH and abnormal hepatic function. About half the patients had malaise and pain related to the intra-arterial infusion therapy. The one year survival rate was 56.9%, and the duration of survival of 50% of the patients was 407 days.

Topics: Adult; Aged; alpha-Fetoproteins; Anorexia; Carcinoma, Hepatocellular; Drug Administration Schedule; Drug Evaluation; Female; Fever; Hepatic Artery; Humans; Infusions, Intra-Arterial; Liver Neoplasms; Male; Maleic Anhydrides; Middle Aged; Nausea; Polystyrenes; Survival Rate; Zinostatin

An early phase II multicentered study of YM 881 (zinostatin stimalamer) was conducted in 36 patients to investigate response and the safety of the drug in malignant tumors. The response could be evaluated in 18 patients, one with brain tumor, 2 with lung cancer, one with breast cancer, one with liver cancer, one with pancreatic cancer, 6 with gastric cancer, and 6 with colon cancer. PR was found in the patient with brain tumor. Major subjective unwanted effects were gastrointestinal symptoms. Objective evidence of hematological changes (thrombocytopenia, decreased hematocrit, and lymphocytopenia) was also obtained.

Topics: Adult; Aged; Anorexia; Brain Neoplasms; Drug Evaluation; Female; Humans; Injections, Intravenous; Lung Neoplasms; Male; Maleic Anhydrides; Middle Aged; Neoplasms; Polystyrenes; Stomach Neoplasms; Thrombocytopenia; Vomiting; Zinostatin

We investigated the possible side effects and efficacy of arterial infusion of SMANCS as compared to Lipiodol + epirubicin TAE for multiple recurrent tumors after hepatic resection. As a result, no significant difference in GOT, GPT, and total bilirubin was observed between the two groups. No significant difference was found in white blood cell count and platelet count, and there was no significant difference in clinical side effects between the two groups. Grade III response rates after arterial infusion of SMANCS were found in 4 patients (66.6%), and these results showed no significant difference as compared to Lipiodol + epirubicin TAE. Proper hepatic arterial infusion of SMANCS appeared to be useful in multiple recurrent tumors from the standpoints of safety and the rate of Lipiodol deposition.

Topics: Adult; Aged; Aged, 80 and over; Anorexia; Antibiotics, Antineoplastic; Antineoplastic Agents; Carcinoma, Hepatocellular; Embolization, Therapeutic; Epirubicin; Female; Hepatectomy; Humans; Infusions, Intra-Arterial; Iodized Oil; Liver Neoplasms; Male; Maleic Anhydrides; Middle Aged; Nausea; Neoplasm Recurrence, Local; Polystyrenes; Zinostatin

A phase I study of YM-881 (zinostatin stimalamer), neocarzinostatin combined with butylesterified styrene maleate, suspended in iodized poppy oil ethyl ester, was conducted in patients with hepatocellular carcinoma by giving single intra-arterial infusions via catheters inserted by Seldinger's method. Four dose levels, 2, 4, 6, and 8 mg, were tested. Major adverse reactions were fever, anorexia, nausea, vomiting, and abnormal hepatic function. Both the incidence and severity of adverse reactions tended to increase with the 8 mg dose. Tumor regression of 50% or more occurred in one receiving 2 mg and one receiving 4 mg. The results of the study suggest that doses of 6 mg or less may be appropriate for the phase II studies.

Topics: Adult; Aged; Anorexia; Carcinoma, Hepatocellular; Drug Administration Schedule; Drug Evaluation; Female; Fever; Hepatic Artery; Humans; Infusions, Intra-Arterial; Liver Neoplasms; Male; Maleic Anhydrides; Middle Aged; Nausea; Polystyrenes; Zinostatin

Topics: Adult; Aged; Anorexia; Antibiotics, Antineoplastic; Carcinoma, Transitional Cell; Fatigue; Humans; Leukopenia; Male; Middle Aged; Neoplasm Recurrence, Local; Urinary Bladder Neoplasms; Zinostatin