Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006019
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2000-07-05
Brief Title:
Phenylbutyrate Plus Azacitidine in Treating Patients With Acute Myeloid Leukemia Myelodysplasia Non-Hodgkins Lymphoma Multiple Myeloma Non-small Cell Lung Cancer or Prostate Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Pilot Study of Sodium Phenylbutyrate Plus Azacytidine
Status:
COMPLETED
Status Verified Date:
2002-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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-Hodgkins lymphoma multiple myeloma non-small cell lung cancer or prostate cancer
PURPOSE Phase II trial to study the effectiveness of phenylbutyrate plus azacitidine in treating patients who have acute myeloid leukemia myelodysplasia non-Hodgkins 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-Hodgkins 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
Determine the ability of azacytidine in vivo to demethylate selected genes known to be transcriptionally repressed in patients with acute myeloid leukemia myelodysplasia non-Hodgkins 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MSKCC-99060 | None | None | None |
| NCI-T99-0091 | None | None | None |