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FR901228 in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors

2014-07-24 14:33:18 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy, such as FR901228, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of FR901228 in treating patients who have locally advanced or metastatic neuroendocrine tumors.

Description

OBJECTIVES:

Primary

- Determine objective response rate in patients with locally advanced or metastatic neuroendocrine tumors treated with FR901288 (depsipeptide).

Secondary

- Determine the toxicity of this drug in these patients.

- Correlate histone acetylation assay results with disease response and immunologic parameters in patients treated with this drug.

OUTLINE: Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete remission (CR) receive 2 additional courses beyond CR.

Patients are followed at 2-4 weeks.

PROJECTED ACCRUAL: A total of 16-25 patients will be accrued for this study within 4-6 months.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Gastrointestinal Carcinoid Tumor

Intervention

romidepsin

Location

Arthur G. James Cancer Hospital at Ohio State University
Columbus
Ohio
United States
43210-1240

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:33:18-0400

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