Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00425477
Status:
COMPLETED
Last Update Posted:
2018-10-05
First Post:
2007-01-19
Brief Title:
Bexarotene and GM-CSF in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
A Phase II Study of Bexarotene Sargromastastin as Agents of Differentiation in MDS and AML
Status:
COMPLETED
Status Verified Date:
2018-09
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 Bexarotene may help cancer or abnormal cells become more like normal cells and to grow and spread more slowly Colony-stimulating factors such as GM-CSF may increase the number of immune cells found in bone marrow or peripheral blood Giving bexarotene together with GM-CSF may be an effective treatment for myelodysplastic syndrome MDS or acute myeloid leukemia
PURPOSE This phase II trial is studying how well giving bexarotene together with GM-CSF works in treating patients with MDS or acute myeloid leukemia
PURPOSE This phase II trial is studying how well giving bexarotene together with GM-CSF works in treating patients with MDS or acute myeloid leukemia
Detailed Description:
OBJECTIVES
Primary
Assess the clinical response in patients with myelodysplastic syndromes or acute myeloid leukemia treated with bexarotene and sargramostim GM-CSF
Secondary
Determine the clinical activity of this regimen in terms of transfusion requirements in these patients
Determine the biological activity of this regimen in terms of biological markers and cytogenetic abnormalities in these patients
Assess the toxicity profile of this regimen in these patients
OUTLINE Patients receive oral bexarotene and sargramostim GM-CSF subcutaneously on days 1-28 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Blood and bone marrow samples are collected at baseline and after 1 or 2 courses of study therapy Samples are examined by flow cytometry for laboratory studies including biological markers and by fluorescent in situ hybridization FISH for cytogenetic changes
After completion of study treatment patients are followed periodically for 6 months
PROJECTED ACCRUAL A total of 18 patients will be accrued for this study
Primary
Assess the clinical response in patients with myelodysplastic syndromes or acute myeloid leukemia treated with bexarotene and sargramostim GM-CSF
Secondary
Determine the clinical activity of this regimen in terms of transfusion requirements in these patients
Determine the biological activity of this regimen in terms of biological markers and cytogenetic abnormalities in these patients
Assess the toxicity profile of this regimen in these patients
OUTLINE Patients receive oral bexarotene and sargramostim GM-CSF subcutaneously on days 1-28 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Blood and bone marrow samples are collected at baseline and after 1 or 2 courses of study therapy Samples are examined by flow cytometry for laboratory studies including biological markers and by fluorescent in situ hybridization FISH for cytogenetic changes
After completion of study treatment patients are followed periodically for 6 months
PROJECTED ACCRUAL A total of 18 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 |
|---|---|---|---|
| JHOC-NA_00003076 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006973 |
| P30CA006973 | NIH | None | None |
| JHOC-J0675 | None | None | None |