Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SKIN0015 | Other Identifier | OnCore |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The V Foundation for Cancer Research | OTHER |
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| arsenic trioxide | Drug | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Biomarker (GLI2 Protein) Levels | baseline to day 33 |
| Measure | Description | Time Frame |
|---|---|---|
| Patients With Stable Disease Post Treatment | Number of patients with stable disease post treatment by RECIST criteria | After 3 cycles of treatment (approx. 61 days) |
| Patients With Progressive Disease Post Treatment by RECIST Criteria |
Not provided
INCLUSION CRITERIA
EXCLUSION CRITERIA
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jean Tang, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Stanford | California | 94305 | United States |
Results will be submitted to scientific journal for publication and shared at scientific meetings
Not provided
Not provided
Not provided
Not provided
Not provided
We will recruit from medical clinic and other physicians who treat metastatic BCC
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | IV ATO | 5 subjects will be treated with arsenic trioxide at 0.3 mg/kg daily via a 2 hour intravenous infusion for 5 days every 28 days (+/- 5 days) for a total of 3 cycles. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
5 patients with BCC who are not eligible for curative loco-regional treatment and have either progressed on, did not tolerate, unwilling to try or ineligible for investigational smoothened antagonist such as GDC 0449, XL 139 (BMS 833923), IPI- 926, LDE225 and PF-04449913 and fit the inclusion/exclusion criteria
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Arsenic Trioxide) | arsenic trioxide IV over 2 hours on days 1-5. Courses repeat every 28 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Biomarker (GLI2 Protein) Levels | We recruited patients with biopsy-confirmed metastatic basal cell carcinoma who were had progressed on SMO inhibitors such as vismodegib (GDC 0449), IPI- 926, LEQ506 and LDE225. | Posted | Mean | Standard Deviation | percentage decrease | baseline to day 33 |
|
|
13 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. arsenic trioxide: Given IV |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| grade 3 infection | Blood and lymphatic system disorders | CTCAE V3 | Non-systematic Assessment | Patient had a grade 3 infection after the cycle 3 arsenic trioxide infusion. Patient recovered after hospital admission and IV antibiotic treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| grade 1 asymptomatic atrial flutter | Cardiac disorders | CTCAE V3 | Non-systematic Assessment | Patient 5discontinued treatment after the first cycle owing to grade 1 asymptomatic atrial flutter. He underwent repeated electrocardiography during a 1-week period, and the arrhythmia spontaneously resolved. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jean Y Tang MD PhD | Stanford University School of Medicine, Department of Dermatology | 650-721-7149 | baileyhi@stanford.edu |
Not provided
| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077237 | Arsenic Trioxide |
| ID | Term |
|---|---|
| D001152 | Arsenicals |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
| 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 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Patients With Stable Disease Post Treatment | Number of patients with stable disease post treatment by RECIST criteria | 4 patients completed 3 cycles of treatment | Posted | Number | participants | After 3 cycles of treatment (approx. 61 days) |
|
|
|
| Secondary | 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 | Posted | Number | participants | After 3 treatment cycles (approx. 61 days) |
|
|
|
| Secondary | Incidence of Grade 3/4 Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Posted | Number | number of occurrences | Baseline to cycle 3 |
|
|
|
| 1 |
| 5 |
| 1 |
| 5 |
|
| grade 4 leukopenia | Blood and lymphatic system disorders | CTCAE V3 | Non-systematic Assessment | grade 4 leukopenia after the cycle 3 arsenic trioxide infusion. Patient recovered after hospital admission and IV antibiotic treatment |
|
|
| transaminitis | Investigations | CTCAE V3 | Non-systematic Assessment | grade 2 transaminitis |
|
Not provided
Not provided
| D018295 |
| Neoplasms, Basal Cell |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |