Arsenic Trioxide in Treating Patients With Basal Cell Carcinoma

NCT01791894 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: IRB-26400SKIN0015
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Conditions

Basal Cell Carcinoma of the Skin; Recurrent Skin Cancer

Outcome Measures

Primary Outcomes (1)

• Percent Change in Biomarker (GLI2 Protein) Levels

  baseline to day 33

Secondary Outcomes (3)

• Patients With Stable Disease Post Treatment

  After 3 cycles of treatment (approx. 61 days)

• Patients With Progressive Disease Post Treatment by RECIST Criteria

  After 3 treatment cycles (approx. 61 days)

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

  Baseline to cycle 3

Study Arms (1)

Treatment (arsenic trioxide)

EXPERIMENTAL

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.

Drug: arsenic trioxide

Interventions

arsenic trioxide DRUG

Given IV

Also known as: Arsenic (III) Oxide, Arsenic Sesquioxide, Arsenous Acid Anhydride, AS2O3, Trisenox

Treatment (arsenic trioxide)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• The V Foundation for Cancer Research: collaborator

Study Sites (1)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell; Skin Neoplasms

Interventions

Arsenic Trioxide

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Arsenicals; Inorganic Chemicals; Oxides; Oxygen Compounds

Results Point of Contact

• Title: Jean Y Tang MD PhD
• Organization: Stanford University School of Medicine, Department of Dermatology

baileyhi@stanford.edu

650-721-7149

Study Officials

• Jean Tang, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Dermatology

Study Record Dates

• First Submitted: February 12, 2013
• First Posted: February 15, 2013
• Study Start: April 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2015
• Last Updated: June 8, 2018
• Results First Posted: October 28, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)