Clinical trial · Interventional
Arsenic Trioxide in Treating Patients With Basal Cell Carcinoma
An Open-label, Biomarker Study of Arsenic Trioxide for the Treatment of Patients With Basal Cell Carcinoma
NCT01791894CI-TRIAL-00033252ATOcompletedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma of the Skin | Skin Basal Cell Carcinoma | ALIAS | 0.90 |
| Recurrent Skin Cancer | Malignant Skin Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| arsenic trioxide | Drug | Arsenic Trioxide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (arsenic trioxide)
- 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.
- interventionNames
- Drug: arsenic trioxide
Primary outcomes (1)
- measure
- Percent Change in Biomarker (GLI2 Protein) Levels
- timeFrame
- baseline to day 33
Secondary outcomes (3)
- measure
- Patients With Stable Disease Post Treatment
- timeFrame
- After 3 cycles of treatment (approx. 61 days)
- description
- Number of patients with stable disease post treatment by RECIST criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.