Prostate Cancer Clinical Trial
Official title:
Pilot Study of Sodium Phenylbutyrate Plus Azacytidine
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer
cells.
PURPOSE: Phase II trial to study the effectiveness of phenylbutyrate plus azacitidine in
treating patients who have acute myeloid leukemia, myelodysplasia, non-Hodgkin's lymphoma,
multiple myeloma, non-small cell lung cancer, or prostate cancer.
OBJECTIVES:
- Determine the ability of azacytidine in vivo to demethylate selected genes known to be
transcriptionally repressed in patients with acute myeloid leukemia, myelodysplasia,
non-Hodgkin's lymphoma, multiple myeloma, non-small cell lung cancer, or prostate
cancer.
- Determine the ability of phenylbutyrate plus azacytidine to induce transcription of
target genes that are known to be repressed as a consequence of DNA methylation in
these patients.
- Determine the effect of this treatment regimen upon gene methylation and histone
acetylation in target cells in these patients.
- Determine the technical feasibility of serially monitoring transcriptional activity and
methylation status of selected genes in vivo in these patients.
- Determine the safety and potential antitumor efficacy of this treatment regimen in
these patients.
OUTLINE: Patients receive azacytidine subcutaneously on days 1-7 and phenylbutyrate IV over
1-2 hours on days 8-12. Patients with acute myeloid leukemia who respond to therapy may
receive a second course approximately 10 days after the end of the first. Subsequent courses
in these patients, and all additional courses in all other patients, are repeated every 21
to 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
;
Masking: Open Label, Primary Purpose: Treatment
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