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 sites75 target enrollmentMay 25, 2009

Overview

No summary available.

Registry

who.int

Start Date

May 25, 2009

End Date

October 10, 2016

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

Melanoma and Skin Cancer Trial

•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