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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.
- 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.
Masking: Open Label, Primary Purpose: Treatment
choline magnesium trisalicylate, dexamethasone, tetradecanoylphorbol acetate, laboratory biomarker analysis
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:18:08-0400
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A phorbol ester found in CROTON OIL with very effective tumor promoting activity. It stimulates the synthesis of both DNA and RNA.
Donor of choline in biosynthesis of choline-containing phosphoglycerides.
An enzyme that is active in the first step of choline phosphoglyceride (lecithin) biosynthesis by catalyzing the phosphorylation of choline to phosphorylcholine in the presence of ATP. Ethanolamine and its methyl and ethyl derivatives can also act as acceptors. EC 220.127.116.11.
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 18.104.22.168.
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