S-3304 in Treating Patients With Advanced Solid Tumors
Summary
RATIONALE: S-3304 may stop or slow the growth of solid tumors by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the effectiveness of S-3304 in treating patients who have solid tumors.
Description
OBJECTIVES:
- Determine the maximum tolerated dose and safety profile of S-3304 in patients with advanced solid tumors.
- Determine the pharmacokinetic profile of this drug in these patients.
- Estimate the starting dose of this drug for subsequent phase II efficacy studies.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive oral S-3304 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 6-8 patients receive escalating doses of S-3304 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 3 of 8 patients experience dose-limiting toxicity.
Patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 6-28 patients will be accrued for this study within 1 year.
Study Design
Primary Purpose: Treatment
Conditions
Unspecified Adult Solid Tumor, Protocol Specific
Intervention
S-3304
Location
Roswell Park Cancer Institute
Buffalo
New York
United States
14263-0001
Status
Active, not recruiting
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00033566
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Nephroma, Mesoblastic
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.
Carcinoma, Ehrlich Tumor
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.
Cystadenocarcinoma, Mucinous
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)
Mastocytoma
A solid tumor consisting of a dense infiltration of MAST CELLS. It is generally benign.
Placebos
Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol.
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