Assessing the feasibility, safety and toxicity of vitamin D following primary treatment of melanoma at high risk of recurrence: A pilot placebo controlled randomised phase II trial

Melanoma and Skin Cancer Trial0 个研究点目标入组 75 人开始时间: 2009年5月25日最近更新: 2021年12月27日

适应症

试验速览

暂无简介。

•i) Primary, histologically confirmed resected stage IIb, IIc, IIIa (N1a) and IIIb (N1a, N2a) cutaneous melanoma
•ii) Wide excision or if there is no wide excision, excision of the primary lesion with clear pathological marigins <90 days prior to randomisation
•iii) Serum corrected calcium and urinary calcium to creatinine ratio within normal range for testing laboratory
•iv) Serum creatinine <=1.5 times the institutional upper limit of normal and estimated Glomerular Filtration Rate (eGFR) within normal range for testing laboratory.
•v) Serum Low-density Lipoprotein <1.5 upper limit of normal (ULN)
•vi) Able to provide written informed consent
•vii) Geographically accessible and willing and able to attend 4 monthly folllow-up visits at Sydney Melanoma Unit (SMU) for 2 years
•viii) Performance status - Eastern Cooperative Oncology Group (ECOG) score between 0 and 2

•i) Patients with a known history of renal calculi
•ii) Patients with a known history of hyperthyroidism
•iii) Patients who have a concomitant invasive cancer other than basal cell carcinoma of the skin or localised squamous cell carcinoma of the skin or a previous such cancer and have been cancer free for less than 5 years
•iv) Any of the following laboratory results (tests must not have been carried out more than 4 weeks prior to randomisation)
•Absolute neutrophil count (ANC) <1.5 x 10 (to the power of 9)/l
•Platelet count <100 x 10 (to the power of 9)/l
•Total bilirubin >1.5 upper limit of normal (ULN)
•Aspartate Amino Transferase (AST), Alanine Amino Transferase (ALT), Alkaline Phosphate (Alk Phos) >2.5 upper limit of normal (ULN)
•v) Patients who are pregnant or lacatating. Women of child bearing potential must have a confirmed negative pregnancy test at study entry
•vi) Patients with a medical or psychological problem which, in the investigators' opinion, would interfere with treatment or follow-up
•vii) Patients with either ocular or mucosal melanoma
•viii) Patients who are currently enrolled in other concurrent experimental treatments or alternative therapies
•ix) Patients cannot have received any other investigational agents or treatment (i.e. chemo, immuno, vaccine or radio therapy) within 30 days of commencing study
•x) Patients should not be taking other agents known to interact with the study drug such as anti-convulsants

发起方

Melanoma and Skin Cancer Trial