Trials / Completed
CompletedNCT00006019
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
Pilot Study of Sodium Phenylbutyrate Plus Azacytidine
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Leukemia
- Lung Cancer
- Lymphoma
- Multiple Myeloma and Plasma Cell Neoplasm
- Myelodysplastic Syndromes
- Prostate Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | azacitidine | |
| DRUG | sodium phenylbutyrate |
Timeline
- Start date
- 2000-05-01
- Completion
- 2003-08-01
- First posted
- 2003-08-29
- Last updated
- 2013-06-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00006019. Inclusion in this directory is not an endorsement.