Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004245
Status:
COMPLETED
Last Update Posted:
2013-01-18
First Post:
2000-01-28
Brief Title:
Sodium Salicylate in Treating Patients With Advanced Myelodysplastic Syndrome Acute Myelogenous Leukemia or Chronic Lymphocytic Leukemia
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase I Study of Salicylate for Adult Patients With Advanced Myelodysplastic Disorders or Acute Myelogenous Leukemia
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:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
PURPOSE Phase I trial to study the effectiveness of sodium salicylate in treating patients who have advanced myelodysplastic syndrome acute myelogenous leukemia or chronic lymphocytic leukemia
PURPOSE Phase I trial to study the effectiveness of sodium salicylate in treating patients who have advanced myelodysplastic syndrome acute myelogenous leukemia or chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES
Evaluate the safety toxicity and pharmacokinetics of sodium salicylate in patients with advanced myelodysplastic syndrome newly diagnosed relapsed or refractory acute myelogenous leukemia or relapsed or refractory chronic lymphocytic leukemia
Define biologic characteristics that influence the likelihood of a clinical response to this drug in this patient population
OUTLINE Patients receive oral sodium salicylate twice a day Intrapatient dose escalation or de-escalation is permitted Treatment continues for up to 6 weeks in the absence of unacceptable toxicity or disease progression Responding patients may continue to receive sodium salicylate beyond the 6-week period
Patients with acute myelogenous leukemia are followed until the end of therapy Patients with myelodysplastic syndrome are followed until death or progression to leukemia
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study within 1 year
Evaluate the safety toxicity and pharmacokinetics of sodium salicylate in patients with advanced myelodysplastic syndrome newly diagnosed relapsed or refractory acute myelogenous leukemia or relapsed or refractory chronic lymphocytic leukemia
Define biologic characteristics that influence the likelihood of a clinical response to this drug in this patient population
OUTLINE Patients receive oral sodium salicylate twice a day Intrapatient dose escalation or de-escalation is permitted Treatment continues for up to 6 weeks in the absence of unacceptable toxicity or disease progression Responding patients may continue to receive sodium salicylate beyond the 6-week period
Patients with acute myelogenous leukemia are followed until the end of therapy Patients with myelodysplastic syndrome are followed until death or progression to leukemia
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study within 1 year
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G99-1661 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |
| P30CA008748 | NIH | None | None |
| MSKCC-99057 | None | None | None |