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Soblidotin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma

2014-08-27 03:55:06 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy such as soblidotin use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of soblidotin in treating patients who have advanced or metastatic soft tissue sarcoma.

Description

OBJECTIVES:

- Determine the objective tumor response rate in patients with advanced or metastatic soft tissue sarcoma with prior exposure to anthracycline-based chemotherapy when treated with soblidotin.

- Determine the duration of response in patients treated with this drug.

- Determine the time to tumor progression in patients treated with this drug.

- Determine the median survival time and 12-month survival rate of patients treated with this drug.

- Determine the quantitative and qualitative toxic effects of this drug in these patients.

- Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive soblidotin IV over 1 hour on days 1 and 8. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for survival.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 12 months.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Sarcoma

Intervention

soblidotin

Location

University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham
Alabama
United States
35294-3300

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:55:06-0400

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PubMed Articles [1 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

An experimental sarcoma of mice.

An experimental sarcoma of mice.

An experimental sarcoma of rats.

Experimentally induced neoplasms of CONNECTIVE TISSUE in animals to provide a model for studying human SARCOMA.

A family of transforming proteins isolated from retroviruses such as MOUSE SARCOMA VIRUSES. They are viral-derived members of the raf-kinase family of serine-theonine kinases.

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