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PXD101 in Treating Patients With Acute Myeloid Leukemia

2014-08-27 03:43:20 | BioPortfolio

Summary

RATIONALE: PXD101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.

PURPOSE: This phase II trial is studying how well PXD101 works in treating patients with relapsed or refractory acute myeloid leukemia or older patients with newly diagnosed acute myeloid leukemia.

Description

OBJECTIVES:

Primary

- Evaluate the response rate (complete response and partial response) in patients with acute myeloid leukemia treated with PXD101.

Secondary

- Evaluate the overall survival of these patients.

- Evaluate the duration of response in these patients.

- Evaluate the toxicity of this drug in these patients.

Tertiary

- Evaluate molecular response to PXD101.

OUTLINE: This is a multicenter study.

Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.

Blood and bone marrow samples are obtained before and after study treatment for laboratory studies.

After completion of study treatment, patients are followed periodically for 1 year.

PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Leukemia

Intervention

belinostat

Location

Tower Cancer Research Foundation
Beverly Hills
California
United States
90211

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:43:20-0400

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