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Tetradecanoylphorbol Acetate, Dexamethasone, and Choline Magnesium Trisalicylate in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

2014-08-27 03:18:08 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy, such as tetradecanoylphorbol acetate (TPA), dexamethasone, and choline magnesium trisalicylate, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase II trial is studying the side effects and how well giving tetradecanoylphorbol acetate together with dexamethasone and choline magnesium trisalicylate works in treating patients with relapsed or refractory acute myeloid leukemia.

Description

OBJECTIVES:

- To determine the anti-leukemic effects and toxicities of tetradecanoylphorbol acetate (TPA) when administered with dexamethasone and choline magnesium trisalicylate (CMT) in patients with relapsed or refractory acute myeloid leukemia (AML).

- To determine if response rates are > 20% in these patients.

- To determine if grade 3 and 4 non-hematologic treatment-related toxicity rates are < 25% in these patients.

- To analyze the effects of TPA when administered with dexamethasone and CMT on the immunophenotype, signaling profile, and nuclear NF-kB expression of AML cells.

OUTLINE: This is a multicenter study.

Patients receive tetradecanoylphorbol acetate (TPA) IV over 1 hour on days 1, 8, and 15. Patients also receive oral dexamethasone every 6 hours and oral choline magnesium trisalicylate every 8 hours beginning 24 hours before TPA and continuing until 24 hours after TPA. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Blood samples may be collected for further analysis.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Leukemia

Intervention

choline magnesium trisalicylate, dexamethasone, tetradecanoylphorbol acetate, laboratory biomarker analysis

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick
New Jersey
United States
08903

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:08-0400

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A condition produced by a deficiency of CHOLINE in animals. Choline is known as a lipotropic agent because it has been shown to promote the transport of excess fat from the liver under certain conditions in laboratory animals. Combined deficiency of choline (included in the B vitamin complex) and all other methyl group donors causes liver cirrhosis in some animals. Unlike compounds normally considered as vitamins, choline does not serve as a cofactor in enzymatic reactions. (From Saunders Dictionary & Encyclopedia of Laboratory Medicine and Technology, 1984)

A phorbol ester found in CROTON OIL with very effective tumor promoting activity. It stimulates the synthesis of both DNA and RNA.

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An enzyme that catalyzes the hydrolysis of ACETYLCHOLINE to CHOLINE and acetate. In the CNS, this enzyme plays a role in the function of peripheral neuromuscular junctions. EC 3.1.1.7.

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