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A phase II trial of arsenic trioxide in patients with metastatic melanoma
Kevin B Kim1, Agop Y Bedikian, Luis H Camacho
1Department of Melanoma Medical Oncology, University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030, USA.
Background:
Arsenic trioxide induces growth inhibition and apoptosis in human melanoma cell lines. Therefore, a Phase II trial was conducted to evaluate the efficacy and toxicity of single-agent arsenic trioxide in patients with Stage IV melanoma.
Methods:
Twenty patients, 10 with metastatic melanoma of cutaneous origin and 10 with metastatic melanoma of choroidal origin, received arsenic trioxide 0.25 mg/kg/day for 5 days, followed by a maintenance dose of 0.35 mg/kg/day twice a week. All patients with melanoma of cutaneous origin and four patients with melanoma of choroidal origin had received prior therapy.
Results:
Single-agent arsenic trioxide did not induce clinical response in this patient population. Eight patients (five with melanoma of cutaneous origin, and three with melanoma of choroidal origin) had disease stabilization for at least six weeks. The median overall survival duration for patients with melanoma of cutaneous origin was 7.9 months, and that of patients with melanoma of choroidal origin has not been reached at a median follow-up duration of 11.8 months. Grade 3 toxicity included neutropenia, fatigue, abdominal pain, and arthralgia. Grade 4 toxicity did not occur.
Conclusions:
Single-agent arsenic trioxide was generally well tolerated; however, no tumor regression was observed in this patient population. Future clinical trials should evaluate arsenic trioxide in combination with other anticancer drugs that may improve its clinical activity in melanoma.
Insights
Single-agent arsenic trioxide did not show efficacy in treating advanced melanoma patients. While generally well-tolerated, it did not induce tumor regression, suggesting combination therapies may be needed for this cancer.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Arsenic trioxide demonstrates anti-cancer properties, inhibiting growth and inducing apoptosis in melanoma cell lines.
- Phase II clinical trials are crucial for evaluating novel cancer therapies in patient populations.
Purpose of the Study:
- To assess the efficacy and toxicity of single-agent arsenic trioxide in patients with Stage IV melanoma.
- To determine the clinical response and survival outcomes in melanoma patients treated with arsenic trioxide.
Main Methods:
- A Phase II trial involving 20 patients with Stage IV melanoma (cutaneous and choroidal origins).
- Patients received arsenic trioxide at a dose of 0.25 mg/kg/day for 5 days, followed by maintenance doses.
- Prior therapy status was documented for all patients.
Main Results:
- Single-agent arsenic trioxide did not achieve clinical response in the studied melanoma patients.
- Disease stabilization was observed in eight patients for at least six weeks.
- Median survival for cutaneous melanoma was 7.9 months; choroidal melanoma median survival was not reached.
Conclusions:
- Single-agent arsenic trioxide was well-tolerated but lacked tumor regression activity in Stage IV melanoma.
- Future research should explore arsenic trioxide in combination with other agents to enhance anti-melanoma effects.
