Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002980
Status:
COMPLETED
Last Update Posted:
2013-02-15
First Post:
1999-11-01
Brief Title:
Decitabine in Treating Patients With Melanoma or Other Advanced Cancer
Sponsor:
California Cancer Consortium
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of the Biologic and Clinical Effects of 5-AZA-2Deoxycytidine DAC in Patients With Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2007-05
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 tumor cells from dividing so they stop growing or die
PURPOSE Phase I trial to study the effectiveness of decitabine in treating patients with stage III or stage IV melanoma or other advanced cancer that has not responded to previous therapy
PURPOSE Phase I trial to study the effectiveness of decitabine in treating patients with stage III or stage IV melanoma or other advanced cancer that has not responded to previous therapy
Detailed Description:
OBJECTIVES I Identify dosage levels of decitabine DAC that show biologic activity and acceptable side effects II Describe the side effects and toxicity of DAC at the doses studied III Determine the steady state DAC serum levels at the doses studied IV Document any clinical responses to DAC
OUTLINE A dose escalation schedule for the administration of decitabine DAC is being used to determine the MTD and biologically active dose Patients are given two 12 hour continuous infusions per day for 3 days at each dose level A minimum of 3 patients are enrolled at each dose level until dose limiting toxicity DLT or biologic activity is observed If DLT or biologic activity is observed at a particular dose level an additional 3 patients are enrolled for a total of 6 If 2 or more patients experience DLT dose escalation is ceased
PROJECTED ACCRUAL Approximately 24 patients will be accrued for this study
OUTLINE A dose escalation schedule for the administration of decitabine DAC is being used to determine the MTD and biologically active dose Patients are given two 12 hour continuous infusions per day for 3 days at each dose level A minimum of 3 patients are enrolled at each dose level until dose limiting toxicity DLT or biologic activity is observed If DLT or biologic activity is observed at a particular dose level an additional 3 patients are enrolled for a total of 6 If 2 or more patients experience DLT dose escalation is ceased
PROJECTED ACCRUAL Approximately 24 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 |
|---|---|---|---|
| NCI-T95-0070 | None | None | None |
| LAC-USC-0C963 | None | None | None |