Phenylbutyrate Plus Azacitidine in Treating Patients With Acute Myeloid Leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Multiple Myeloma, Non-small Cell Lung Cancer, or Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00006019|
Recruitment Status : Completed
First Posted : August 29, 2003
Last Update Posted : June 24, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lung Cancer Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Prostate Cancer||Drug: azacitidine Drug: sodium phenylbutyrate||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Sodium Phenylbutyrate Plus Azacytidine|
|Study Start Date :||May 2000|
|Actual Study Completion Date :||August 2003|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006019
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Peter Maslak, MD||Memorial Sloan Kettering Cancer Center|