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Bryostatin 1 Plus Gemcitabine in Treating Patients With Advanced Cancer

2014-08-27 03:58:21 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of bryostatin 1 plus gemcitabine in treating patients who have advanced cancer that has not responded to previous treatment.

Description

OBJECTIVES:

- Determine the maximum tolerated dose of gemcitabine when given concurrently with bryostatin 1 to patients with advanced refractory cancer.

- Access the pattern of toxicity of this drug regimen in this patient population.

- Determine the objective response rate, duration of response, and overall survival in patients treated with this drug regimen.

- Determine the influence of bryostatin 1 on the pharmacokinetics of gemcitabine.

OUTLINE: This is a dose escalation study.

Patients receive gemcitabine IV over 30 minutes, immediately followed by bryostatin 1 IV over 24 hours, weekly for 3 weeks (days 1, 8, and 15). Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of gemcitabine and bryostatin 1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxic effects.

PROJECTED ACCRUAL: Approximately 2-3 patients per month will be accrued for this study.

Study Design

Primary Purpose: Treatment

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Intervention

bryostatin 1, gemcitabine hydrochloride

Location

Barbara Ann Karmanos Cancer Institute
Detroit
Michigan
United States
48201-1379

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:58:21-0400

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Medical and Biotech [MESH] Definitions

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.

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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)

A solid tumor consisting of a dense infiltration of MAST CELLS. It is generally benign.

An adenocarcinoma in which the tumor elements are arranged as finger-like processes or as a solid spherical nodule projecting from an epithelial surface.

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