Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-03 @ 10:38 AM
Study NCT ID:
NCT01791894
Status:
COMPLETED
Last Update Posted:
2018-06-08
First Post:
2013-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Arsenic Trioxide in Treating Patients With Basal Cell Carcinoma
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
An Open-label, Biomarker Study of Arsenic Trioxide for the Treatment of Patients With Basal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2016-10
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:
ATO
Brief Summary:
This pilot clinical trial studies arsenic trioxide in treating patients with basal cell carcinoma. Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stop them from dividing
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine whether administration of arsenic trioxide (ATO) to patients with basal cell carcinoma is associated with a reduction in Gli messenger ribonucleic acid (mRNA) and protein levels in tumor biopsy samples, when compared to baseline levels.
SECONDARY OBJECTIVES:
I. To determine whether there is evidence of tumor size reduction of ATO against basal cell carcinoma in humans.
OUTLINE:
Patients receive arsenic trioxide intravenously (IV) over 2 hours on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
I. To determine whether administration of arsenic trioxide (ATO) to patients with basal cell carcinoma is associated with a reduction in Gli messenger ribonucleic acid (mRNA) and protein levels in tumor biopsy samples, when compared to baseline levels.
SECONDARY OBJECTIVES:
I. To determine whether there is evidence of tumor size reduction of ATO against basal cell carcinoma in humans.
OUTLINE:
Patients receive arsenic trioxide intravenously (IV) over 2 hours on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| SKIN0015 | OTHER | OnCore | View |