The prognosis for patients who have primary cutaneous melanomas that are larger than 4 mm in thickness, are ulcerated and larger than 2 mm in thickness, or are diagnosed with nodal micrometastases is poor and limited treatment options are currently available.
Recently, research has indicated that vitamin D may delay the recurrence of melanoma and improve a patient’s rate of overall survival. Researchers from the Melanoma Institute Australia in North Sydney, Australia, are conducting a pilot placebo-controlled phase II trial that randomly assigns patients into groups to assess the safety, feasibility, and toxicity of on oral loading dose of vitamin D (500,000 IU) followed by a monthly oral dose of vitamin D (50,000 IU) for 2 years.
The study is confined to patients who were treated with a wide excision of the primary for their cutaneous melanoma. Enrollment is open to patients between the ages of 18 and 79 years whose disease is stage IIb, IIc, IIIa (N1a, N2a), or IIIb (N1a, N2a) and have completed primary surgical treatment. Patients will be randomly assigned 2:1 to receive vitamin D treatment or placebo.
The primary endpoints are safety, adherence, and sufficiency of dose. Secondary endpoints of the clinical trial are progression-free survival and participation. If favorable outcomes are measured, this study will become the basis for a multicenter phase III trial.
Patients with primary cutaneous melanomas that are ulcerated and >2 mm in thickness, >4 mm in thickness and those with nodal micrometastases at diagnosis, have few options for adjuvant treatment.
Recent studies have suggested a role for vitamin D to delay melanoma recurrence and improve overall prognosis.