Trial Outcomes & Findings for Arsenic Trioxide in Treating Patients With Basal Cell Carcinoma (NCT NCT01791894)

NCT ID: NCT01791894

Last Updated: 2018-06-08

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: baseline to day 33
• Results posted on: 2018-06-08

Participant Flow

We will recruit from medical clinic and other physicians who treat metastatic BCC

Participant milestones

Measure	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.
Overall Study STARTED	5
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	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.
Overall Study Adverse Event	1

Baseline Characteristics

Arsenic Trioxide in Treating Patients With Basal Cell Carcinoma

Baseline characteristics by cohort

Measure	Treatment (Arsenic Trioxide) n=5 Participants arsenic trioxide IV over 2 hours on days 1-5. Courses repeat every 28 days
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to day 33

Population: 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.

Outcome measures

Measure	Treatment (Arsenic Trioxide) n=5 Participants 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 laboratory biomarker analysis: Correlative studies
Percent Change in Biomarker (GLI2 Protein) Levels	75 percentage decrease Standard Deviation 11

SECONDARY outcome

Timeframe: After 3 cycles of treatment (approx. 61 days)

Population: 4 patients completed 3 cycles of treatment

Number of patients with stable disease post treatment by RECIST criteria

Outcome measures

Measure	Treatment (Arsenic Trioxide) n=4 Participants 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 laboratory biomarker analysis: Correlative studies
Patients With Stable Disease Post Treatment	3 participants

SECONDARY outcome

Timeframe: After 3 treatment cycles (approx. 61 days)

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

Outcome measures

Measure	Treatment (Arsenic Trioxide) n=4 Participants 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 laboratory biomarker analysis: Correlative studies
Patients With Progressive Disease Post Treatment by RECIST Criteria	1 participants

SECONDARY outcome

Timeframe: Baseline to cycle 3

Outcome measures

Measure	Treatment (Arsenic Trioxide) n=5 Participants 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 laboratory biomarker analysis: Correlative studies
Incidence of Grade 3/4 Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0	2 number of occurrences

Adverse Events

Treatment (Arsenic Trioxide)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment (Arsenic Trioxide) n=5 participants at risk 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
Blood and lymphatic system disorders grade 3 infection	20.0% 1/5 • Number of events 1 • 13 weeks
Blood and lymphatic system disorders grade 4 leukopenia	20.0% 1/5 • Number of events 1 • 13 weeks

Other adverse events

Measure	Treatment (Arsenic Trioxide) n=5 participants at risk 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
Cardiac disorders grade 1 asymptomatic atrial flutter	20.0% 1/5 • Number of events 1 • 13 weeks
Investigations transaminitis	20.0% 1/5 • Number of events 1 • 13 weeks

Additional Information

Jean Y Tang MD PhD

Stanford University School of Medicine, Department of Dermatology

Phone: 650-721-7149

Email: baileyhi@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place