KRN5500 in Treating Patients With Solid Tumors
Summary
RATIONALE: Drugs used in chemotherapy, such as KRN5500, work in different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of KRN5500 in treating patients who have solid tumors.
Description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and dose-limiting toxic effects of KRN5500 in patients with solid tumors.
- Assess the safety of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the response, by 3'deoxy- 3'fluorothymidine positron emission tomography scan, of a subset of patients treated with this drug.
Secondary
- Determine, preliminarily, the antitumor activity of this drug in these patients.
- Determine pharmacodynamic relationships for the pharmacological effect of this drug upon surrogate markers of activity and toxicity in these patients.
- Compare the toxicity profiles for the 1-hour and 72-hour infusion administration schedules of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive KRN5500 IV over 24-72 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-3 patients receive KRN5500 at the starting dose over escalating infusion durations. After the longest duration of infusion time is safely reached, cohorts of 3-6 patients receive escalating doses of KRN5500 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive treatment with KRN5500 at the recommended phase II dose.
Patients are followed every 4 weeks until resolution of all toxicity.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 9-12 months.
Study Design
Primary Purpose: Treatment
Conditions
Unspecified Adult Solid Tumor, Protocol Specific
Intervention
KRN5500
Location
Louisiana State University Health Sciences Center - Shreveport
Shreveport
Louisiana
United States
71130-3932
Status
Active, not recruiting
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00017238
- 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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