Arsenic Trioxide in Treating Patients With Basal Cell Carcinoma
This study is currently recruiting participants.
Verified April 2013 by Stanford University
Sponsor:
Stanford University
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01791894
First received: February 12, 2013
Last updated: April 16, 2013
Last verified: April 2013
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Purpose
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
| Condition | Intervention |
|---|---|
|
Basal Cell Carcinoma of the Skin Recurrent Skin Cancer |
Drug: arsenic trioxide Other: laboratory biomarker analysis |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | An Open-label, Biomarker Study of Arsenic Trioxide for the Treatment of Patients With Basal Cell Carcinoma |
Resource links provided by NLM:
Further study details as provided by Stanford University:
Primary Outcome Measures:
- Percent decrease in GLI2 protein levels [ Time Frame: From baseline to day 5 of course 2 ] [ Designated as safety issue: No ]Analyzed using nonparametric methods (Wilcoxon sign rank test).
Secondary Outcome Measures:
- Change in tumor GLI1 protein or mRNA levels [ Time Frame: From baseline to day 5 of course 2 ] [ Designated as safety issue: No ]Analyzed using Wilcoxon sign rank test.
- Tumor size change in the longest diameter, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: From baseline to 1 year ] [ Designated as safety issue: No ]Analyzed using Wilcoxon sign rank test.
- Proportion of subjects with complete response, partial response, stable disease, or disease progression by RECIST criteria [ Time Frame: At 3 months ] [ Designated as safety issue: No ]
- Incidence of adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]Adverse events (AEs) attributable to arsenic trioxide will be collected and tabulated for cumulative evaluation.
| Estimated Enrollment: | 5 |
| Study Start Date: | April 2013 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (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.
|
Drug: arsenic trioxide
Given IV
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with basal cell carcinoma (BCC)
- Patients 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
- Include the following: ability to understand and the willingness to sign a written informed consent document
- Patients must have evaluable tumor and be potentially eligible for pre and post ATO tumor biopsy
Exclusion Criteria:
- Concurrent use of other Investigational agents is prohibited
- Patients with cardiac arrhythmias are excluded
- Patients receiving potassium wasting diuretics or amphotericin, while not excluded, must be noted to have theoretically increased arrhythmia risks with ATO
- 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 women and breastfeeding women are excluded from this study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01791894
Locations
| United States, California | |
| Stanford University | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Irene Bailey-Healy 408-892-7261 baileyhi@stanford.edu | |
| Principal Investigator: Jean Tang | |
Sponsors and Collaborators
Stanford University
Investigators
| Principal Investigator: | Jean Tang | Stanford University |
More Information
No publications provided
| Responsible Party: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT01791894 History of Changes |
| Other Study ID Numbers: | SKIN0015, NCI-2013-00387 |
| Study First Received: | February 12, 2013 |
| Last Updated: | April 16, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Carcinoma, Basal Cell Carcinoma Skin Neoplasms Carcinoma, Basosquamous Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms by Site Skin Diseases Neoplasms, Basal Cell Neoplasms, Squamous Cell Arsenic trioxide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013