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Belinostat

Histone Deacetylase Inhibitors

Enzyme Inhibitors

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.

belinostat

laboratory biomarker analysis

Kenneth Foon

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. 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.

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

I. Evaluate the overall survival of these patients. II. Evaluate the duration of response in these patients. III. Evaluate the toxicity of this drug in these patients.

TERTIARY OBJECTIVES:

I. Evaluate molecular response to PXD101.

OUTLINE:

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.

PXD101 in Treating Patients With Acute Myeloid Leukemia

A Phase 2 Study of PXD101 in Patients With Relapsed or Refractory Acute Myelogenous Leukemia or Patients Over 60 With Newly-Diagnosed Acute Myelogenous Leukemia

Clinical responses were measured according to International Working Group criteria. Bone marrow studies were repeated at a minimum of every three cycles. Per International Working Group criteria: Complete Response (CR): Repeat bone marrow show \<5% myeloblasts, and peripheral blood evaluations lasting \>=2 months of hemoglobin(\>110 g/L), neutrophils(\>=1.5x10\^9/L), platelets(\>=100x10\^9/L), blasts (0%) and no dysplasia

Survival endpoints will be summarized by the method of Kaplan-Meier

From time of documented treatment response (CR or PR) until progression of death. Complete Response (CR): Repeat bone marrow show \<5% myeloblasts, and peripheral blood evaluations lasting \>=2 months of hemoglobin(\>110 g/L), neutrophils(\>=1.5x10\^9/L), platelets(\>=100x10\^9/L), blasts (0%) and no dysplasia. Partial Resonse (PR): requires the same hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to a post-treatment value of 5% to 25% in the bone marrow aspirate. (If the pre-treatment blast percentage was 50-100%, this must decrease to a value between 5-25%. If the pre-treatment blast percentage was 20-49%, this must decrease by at least half to a value greater than 5%.) A value ≤ 5% is also considered a PR if Auer rods are present.

Assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 3 and above toxicities possibly, probably or definitely related to treatment.

National Cancer Institute (NCI)

"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

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.

belinostat: Given IV

laboratory biomarker analysis: Correlative studies

Treatment (Belinostat)

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

DCC Project Administrator

Complete Response Rate

Overall Survival

There were no formal CRs or PRs seen among the first cohort of 12 patients, resulting in the study's closure. As a result data were not collected.The study was completed as planned and stopped due to futility as written per protocol. It was not terminated prematurely as accrual proceeded per protocol.

Spots Global Cancer Trial Database for PXD101 in Treating Patients With Acute Myeloid Leukemia

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