Biomaterial Database

Phase I-II trial of a 5-day continuous infusion of vinblastine sulfate. 1984

J Zeffren, and A Yagoda, and D Kelsen, and R Winn

Vinblastine sulfate was administered to 28 patients as a continuous infusion for five consecutive days in doses of 0.75 to 2.0 mg/m2. Pharmacokinetic studies in 4 patients showed that plasma levels increased rapidly after beginning the infusion with a steady state occurring in 10-48 hours at 2 ng/ml for 1.25 mg/m2, and 5-8 ng/ml for 2.0 mg/m2. The T 1/2 b after completion of the infusion was 19 hours. Dose-limiting toxicity was myelosuppression. A partial remission of four months duration was observed in a patient with adenocarcinoma of the gastroesophageal junction. One patient, who had been heavily pretreated, obtained partial remission while three patients with breast cancer had a minor response. There was no response in 10 patients with hypernephroma. The suggested starting dose is 2 mg/m2 for un-pretreated cases and 1.75 mg/m2 daily for 5 consecutive days monthly for prior treated cases.

UI	MeSH Term	Description	Entries
D007263	Infusions, Parenteral	The administration of liquid medication, nutrient, or other fluid through some other route than the alimentary canal, usually over minutes or hours, either by gravity flow or often by infusion pumping.	Intra-Abdominal Infusions,Intraperitoneal Infusions,Parenteral Infusions,Peritoneal Infusions,Infusion, Intra-Abdominal,Infusion, Intraperitoneal,Infusion, Parenteral,Infusion, Peritoneal,Infusions, Intra-Abdominal,Infusions, Intraperitoneal,Infusions, Peritoneal,Intra Abdominal Infusions,Intra-Abdominal Infusion,Intraperitoneal Infusion,Parenteral Infusion,Peritoneal Infusion
D007700	Kinetics	The rate dynamics in chemical or physical systems.
D007970	Leukopenia	A decrease in the number of LEUKOCYTES in a blood sample below the normal range (LEUKOCYTE COUNT less than 4000).	Leukocytopenia,Leukocytopenias,Leukopenias
D008297	Male		Males
D008875	Middle Aged	An adult aged 45 - 64 years.	Middle Age
D009369	Neoplasms	New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.	Benign Neoplasm,Cancer,Malignant Neoplasm,Tumor,Tumors,Benign Neoplasms,Malignancy,Malignant Neoplasms,Neoplasia,Neoplasm,Neoplasms, Benign,Cancers,Malignancies,Neoplasias,Neoplasm, Benign,Neoplasm, Malignant,Neoplasms, Malignant
D004341	Drug Evaluation	Any process by which toxicity, metabolism, absorption, elimination, preferred route of administration, safe dosage range, etc., for a drug or group of drugs is determined through clinical assessment in humans or veterinary animals.	Evaluation Studies, Drug,Drug Evaluation Studies,Drug Evaluation Study,Drug Evaluations,Evaluation Study, Drug,Evaluation, Drug,Evaluations, Drug,Studies, Drug Evaluation,Study, Drug Evaluation
D005260	Female		Females
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000293	Adolescent	A person 13 to 18 years of age.	Adolescence,Youth,Adolescents,Adolescents, Female,Adolescents, Male,Teenagers,Teens,Adolescent, Female,Adolescent, Male,Female Adolescent,Female Adolescents,Male Adolescent,Male Adolescents,Teen,Teenager,Youths