Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012376
Status:
COMPLETED
Last Update Posted:
2013-01-09
First Post:
2001-03-03
Brief Title:
Chemotherapy Plus Sargramostim in Treating Patients With Refractory Myeloid Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Dose Finding Study of Bryostatin-1 and GM-CSF in Refractory Myeloid Malignancies
Status:
COMPLETED
Status Verified Date:
2013-01
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:
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 Phase I trial to study the effectiveness of bryostatin 1 combined with sargramostim in treating patients who have refractory myeloid cancer
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximally tolerated dose of continuous intravenous infusion bryostatin-1 when given in combination with GM-CSF
II To describe and quantify the frequency of toxicity of the combination of continuous intravenous infusion bryostatin-1 and subcutaneously administered GM-CSF
SECONDARY OBJECTIVES
I To describe the impact of the combination of bryostatin-1 and GM-CSF on the differentiation and cell cycle distribution of myeloid cells in vivo
II To describe the impact of the combination of bryostatin-1 and GM-CSF on T lymphocyte populations
III To assess the pharmacokinetics of continuous infusion bryostatin-1
OUTLINE This is a dose-escalation study of bryostatin 1
Patients receive bryostatin 1 IV continuously and sargramostim GM-CSF subcutaneously once daily on days 1-21 Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity Patients with disease stabilization or improvement may continue treatment for up to 12 courses
Cohorts of 2 patients receive escalating doses of bryostatin 1 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 30 of patients experience dose-limiting toxicity
PROJECTED ACCRUAL A maximum of 45 patients will be accrued for this study within 12-18 months
I To determine the maximally tolerated dose of continuous intravenous infusion bryostatin-1 when given in combination with GM-CSF
II To describe and quantify the frequency of toxicity of the combination of continuous intravenous infusion bryostatin-1 and subcutaneously administered GM-CSF
SECONDARY OBJECTIVES
I To describe the impact of the combination of bryostatin-1 and GM-CSF on the differentiation and cell cycle distribution of myeloid cells in vivo
II To describe the impact of the combination of bryostatin-1 and GM-CSF on T lymphocyte populations
III To assess the pharmacokinetics of continuous infusion bryostatin-1
OUTLINE This is a dose-escalation study of bryostatin 1
Patients receive bryostatin 1 IV continuously and sargramostim GM-CSF subcutaneously once daily on days 1-21 Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity Patients with disease stabilization or improvement may continue treatment for up to 12 courses
Cohorts of 2 patients receive escalating doses of bryostatin 1 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 30 of patients experience dose-limiting toxicity
PROJECTED ACCRUAL A maximum of 45 patients will be accrued for this study within 12-18 months
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 |
|---|---|---|---|
| P01CA015396 | NIH | None | httpsreporternihgovquickSearchP01CA015396 |
| J0051 | None | None | None |