Vitamin D following primary treatment of melanoma at high risk of recurrence

Phase 2

Completed

• Conditions: Cutaneous malignant melanoma; Cancer - Malignant melanoma

• Registration Number: ACTRN12609000351213
• Lead Sponsor: Melanoma and Skin Cancer Trial

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-25
• Study Completion: 2016-10-10
• Last Update Posted: 27 December 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified