Back to results

Arsenic Trioxide in Treating Patients With Basal Cell Carcinoma (ATO)

Primary Purpose

Basal Cell Carcinoma of the Skin, Recurrent Skin Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

arsenic trioxide

About this trial

This is an interventional basic science trial for Basal Cell Carcinoma of the Skin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA

Basal cell carcinoma (BCC)
Ineligible for curative locoregional treatment and have either progressed on, did not tolerate, unwilling to try or ineligible for investigational smoothened antagonist such as vismodegib (GDC 0449), XL 139 (BMS 833923), IPI- 926, LDE225 and PF-04449913
Life expectancy estimate > 3 months
Performance status Eastern Cooperative Oncology Group (ECOG) 0-2
Absolute neutrophil count ≥ 1,500/mcL
Platelets ≥ 100,000/mcL
Total bilirubin within normal institutional limits
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 x institutional upper limit of normal
Creatinine within normal institutional limits
Corrected QT interval (QTC) by 12 lead electrocardiogram (EKG) < 450 msecs
Serum potassium within normal limits
Magnesium within normal limits
Calcium within normal limits
Ability to understand and the willingness to sign a written informed consent document
Evaluable tumor and be potentially eligible for pre and post ATO tumor biopsy
Receiving potassium wasting diuretics or amphotericin, while not excluded, must be noted to have theoretically increased arrhythmia risks with ATO

EXCLUSION CRITERIA

Concurrent use of other Investigational agents
Cardiac arrhythmias
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, recurrent seizure history or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant or lactating

Sites / Locations

Stanford University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (arsenic trioxide)

Arm Description

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.

Outcomes

Primary Outcome Measures

Percent Change in Biomarker (GLI2 Protein) Levels

Secondary Outcome Measures

Patients With Stable Disease Post Treatment

Number of patients with stable disease post treatment by RECIST criteria

Patients With Progressive Disease Post Treatment by RECIST Criteria

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

Full Information

NCT ID

NCT01791894

First Posted

February 12, 2013

Last Updated

May 8, 2018

Sponsor

Stanford University

Collaborators

The V Foundation for Cancer Research

1. Study Identification

Unique Protocol Identification Number

NCT01791894

Brief Title

Arsenic Trioxide in Treating Patients With Basal Cell Carcinoma

Acronym

ATO

Official Title

An Open-label, Biomarker Study of Arsenic Trioxide for the Treatment of Patients With Basal Cell Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

The V Foundation for Cancer Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Basal Cell Carcinoma of the Skin, Recurrent Skin Cancer

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment (arsenic trioxide)

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

arsenic trioxide

Other Intervention Name(s)

Arsenic (III) Oxide, Arsenic Sesquioxide, Arsenous Acid Anhydride, AS2O3, Trisenox

Intervention Description

Given IV

Primary Outcome Measure Information:

Title

Percent Change in Biomarker (GLI2 Protein) Levels

Time Frame

baseline to day 33

Secondary Outcome Measure Information:

Title

Patients With Stable Disease Post Treatment

Description

Number of patients with stable disease post treatment by RECIST criteria

Time Frame

After 3 cycles of treatment (approx. 61 days)

Title

Patients With Progressive Disease Post Treatment by RECIST Criteria

Description

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

Time Frame

After 3 treatment cycles (approx. 61 days)

Title

Incidence of Grade 3/4 Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0

Time Frame

Baseline to cycle 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

INCLUSION CRITERIA Basal cell carcinoma (BCC) Ineligible for curative locoregional treatment and have either progressed on, did not tolerate, unwilling to try or ineligible for investigational smoothened antagonist such as vismodegib (GDC 0449), XL 139 (BMS 833923), IPI- 926, LDE225 and PF-04449913 Life expectancy estimate > 3 months Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 Absolute neutrophil count ≥ 1,500/mcL Platelets ≥ 100,000/mcL Total bilirubin within normal institutional limits Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 x institutional upper limit of normal Creatinine within normal institutional limits Corrected QT interval (QTC) by 12 lead electrocardiogram (EKG) < 450 msecs Serum potassium within normal limits Magnesium within normal limits Calcium within normal limits Ability to understand and the willingness to sign a written informed consent document Evaluable tumor and be potentially eligible for pre and post ATO tumor biopsy Receiving potassium wasting diuretics or amphotericin, while not excluded, must be noted to have theoretically increased arrhythmia risks with ATO EXCLUSION CRITERIA Concurrent use of other Investigational agents Cardiac arrhythmias Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, recurrent seizure history or psychiatric illness/social situations that would limit compliance with study requirements Pregnant or lactating

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean Tang, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University Medical Center

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Results will be submitted to scientific journal for publication and shared at scientific meetings

Learn more about this trial

Arsenic Trioxide in Treating Patients With Basal Cell Carcinoma

We'll reach out to this number within 24 hrs