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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
OBJECTIVES: I. Determine the maximum tolerated dose of T138067 sodium that can be given to patients with advanced refractory cancer on a 28-day schedule and establish a dose for further study. II. Evaluate the safety and dose limiting toxicity of T138067 sodium in these patients. III. Determine the pharmacokinetic parameters after a single intravenous dose of this agent in these patients. IV. Obtain safety data and preliminary efficacy information after repetition of single doses of T138067 sodium in these patients.
OUTLINE: This is an open label, dose escalation study. Patients receive T138067 sodium by IV over 3 hours. Patients may be retreated every 4 weeks for up to 6 courses (6 months total) in the absence of disease progression or dose limiting toxicity (DLT). At least 3 patients are treated at each dose level in the absence of DLT. The maximum tolerated dose is defined as the dose level where 2 of 3-6 patients experience DLT.
PROJECTED ACCRUAL: Approximately 3-24 patients will be accrued into this study.
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:58:45-0400
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A solid, unencapsulated tumor of the KIDNEY composed of spindle mesenchymal cells that resemble FIBROBLASTS or muscle cells. The homogeneous mass typically extends into the renal parenchyma and replaces most of the kidney. In most cases, mesoblastic nephroma is benign and occurs in the fetus or newborn, and rarely in the older child or the adult.
A transplantable, poorly differentiated malignant tumor which appeared originally as a spontaneous breast carcinoma in a mouse. It grows in both solid and ascitic forms.
Sodium or sodium compounds used in foods or as a food. The most frequently used compounds are sodium chloride or sodium glutamate.
A subclass of sodium channel blockers that are specific for EPITHELIAL SODIUM CHANNELS.
A malignant cystic or semisolid tumor most often occurring in the ovary. Rarely, one is solid. This tumor may develop from a mucinous cystadenoma, or it may be malignant at the onset. The cysts are lined with tall columnar epithelial cells; in others, the epithelium consists of many layers of cells that have lost normal structure entirely. In the more undifferentiated tumors, one may see sheets and nests of tumor cells that have very little resemblance to the parent structure. (Hughes, Obstetric-Gynecologic Terminology, 1972, p184)
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