Arsenic Trioxide in Treating Patients With Basal Cell Carcinoma

Phase 1

Completed

• Conditions: Basal Cell Carcinoma of the Skin; Recurrent Skin Cancer
• Interventions: Drug: arsenic trioxide

• Registration Number: NCT01791894
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2013-02-12
• Study First Submitted QC: 2013-02-12
• Study First Posted: 2013-02-15
• Study Start: 2013-04
• Primary Completion: 2013-11
• Study Completion: 2015-11
• Results First Submitted: 2016-04-27
• Results First Submitted QC: 2016-09-09
• Status Verified: 2016-10
• Results First Posted: 2016-10-28
• Last Update Submitted: 2018-05-08
• Last Update Posted: 2018-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (arsenic trioxide)	arsenic trioxide	Patients receive arsenic trioxide IV over 2 hours on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Percent Change in Biomarker (GLI2 Protein) Levels	baseline to day 33

Secondary Outcome Measures

Name	Time	Method
Patients With Stable Disease Post Treatment	After 3 cycles of treatment (approx. 61 days)	Number of patients with stable disease post treatment by RECIST criteria
Patients With Progressive Disease Post Treatment by RECIST Criteria	After 3 treatment cycles (approx. 61 days)	Patients with a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Incidence of Grade 3/4 Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0	Baseline to cycle 3

Trial Locations

Locations (1)

Stanford University Medical Center; 🇺🇸 Stanford, California, United States