Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008320
Status:
COMPLETED
Last Update Posted:
2016-12-06
First Post:
2001-01-06
Brief Title:
Ceramide Cream in Treating Women With Cutaneous Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Study Of Topical Ceramide Lipids As Treatment For Cutaneous Breast Cancer
Status:
COMPLETED
Status Verified Date:
2016-12
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 II trial to study the effectiveness of ceramide cream in treating women who have cutaneous breast cancer
PURPOSE Phase II trial to study the effectiveness of ceramide cream in treating women who have cutaneous breast cancer
Detailed Description:
OBJECTIVES I Determine the objective response rate in women with cutaneous breast cancer treated with topical ceramide cream II Determine the time to progression in patients treated with this regimen III Determine the toxicity of this regimen in these patients IV Assess the quality of life of these patients treated with this regimen
OUTLINE Topical ceramide cream is applied to all cutaneous lesions twice daily Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline and then at 1 and 3 months Patients are followed every 3 months for 1 year and then every 6 months for 4 years
OUTLINE Topical ceramide cream is applied to all cutaneous lesions twice daily Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline and then at 1 and 3 months Patients are followed every 3 months for 1 year and then every 6 months for 4 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 |
|---|---|---|---|
| CDR0000068397 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02368 | REGISTRY | None | None |