Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006240
Status:
COMPLETED
Last Update Posted:
2015-04-28
First Post:
2000-09-11
Brief Title:
Phenylbutyrate Dexamethasone and Sargramostim in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Pilot Study of Phenylbutyrate Dexamethasone and GM-CSF in Refractory or Relapsed t821 Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2002-11
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 Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of chemotherapy
PURPOSE Phase II trial to study the effectiveness of combining phenylbutyrate dexamethasone and sargramostim in treating patients who have refractory or relapsed acute myeloid leukemia
PURPOSE Phase II trial to study the effectiveness of combining phenylbutyrate dexamethasone and sargramostim in treating patients who have refractory or relapsed acute myeloid leukemia
Detailed Description:
OBJECTIVES
Determine the objective response complete hematologic remission induction of phenylbutyrate dexamethasone and sargramostim GM-CSF in patients with refractory or relapsed t821 acute myeloid leukemia
Determine the correlation between histone acetylation differentiation and apoptosis in bone marrow mononuclear cells with response rate in patients treated with this regimen
Determine the overall survival of patients on this regimen
Determine the correlation between histone acetylation differentiation and apoptosis in bone marrow mononuclear cells with pharmacokinetics of this regimen in these patients
Determine the safety and toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive phenylbutyrate IV continuously and sargramostim GM-CSF subcutaneously on days 1-7 and 15-21 Patients also receive oral dexamethasone on days 1-4 and 15-18 Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity until complete hematologic remission is induced Patients with stable disease at the end of 1 course receive at least 2 additional courses
Patients are followed twice a week for 3 months monthly for 1 year every three months for the next 4 years and then annually thereafter
PROJECTED ACCRUAL A total of 9-24 patients will be accrued for this study in at least 2 years
Determine the objective response complete hematologic remission induction of phenylbutyrate dexamethasone and sargramostim GM-CSF in patients with refractory or relapsed t821 acute myeloid leukemia
Determine the correlation between histone acetylation differentiation and apoptosis in bone marrow mononuclear cells with response rate in patients treated with this regimen
Determine the overall survival of patients on this regimen
Determine the correlation between histone acetylation differentiation and apoptosis in bone marrow mononuclear cells with pharmacokinetics of this regimen in these patients
Determine the safety and toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive phenylbutyrate IV continuously and sargramostim GM-CSF subcutaneously on days 1-7 and 15-21 Patients also receive oral dexamethasone on days 1-4 and 15-18 Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity until complete hematologic remission is induced Patients with stable disease at the end of 1 course receive at least 2 additional courses
Patients are followed twice a week for 3 months monthly for 1 year every three months for the next 4 years and then annually thereafter
PROJECTED ACCRUAL A total of 9-24 patients will be accrued for this study in at least 2 years
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 |
|---|---|---|---|
| NCI-171 | None | None | None |
| NHLBI-00-H-0156 | None | None | None |