melanoma MedDRA version: 12.0 Level: HLT Classification code 10027156 Term: Skin melanomas (excl ocular)
Conditions
Interventions
Trade Name: DIBASE*IM OS 6F 1ML 100000UI/M
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Colecalciferol
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concent
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 18-75 years of age with newly diagnosed histologically proven resected melanoma; stage: IIa (T2b, T3a), IIb (T3b T4a) and IIc (T4b), N0, M0; signed informed consent; willingness to provide blood samples; performance Status of 0-1 (ECOG); hematopoietic functionality at the entry of the study: leukocytes, platelets, haemoglobin and neutrophiles within the normal limits of laboratory references; hepatic and renal functionality at the entry of the study: LDH, bilirubin, AST, ALT, alkaline phosphatase, BUN and serum creatinine in the normal range of each laboratory; serum and urinary calcium within the upper limit of laboratory references. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: primary not cutaneous melanoma; clinical/radiological evidence or laboratory/pathology report of not completely resected melanoma; history of cancer (other than CIN and NMSC); current daily use of at least 600 IU/day of supplemental vitamin D or calcitriol or high dose of calcium therapy (e.g. calcium citrate with vitamin D) within the prior 6 months and supplemental calcium greater than 600 mg calcium per day during study; history of recurrent renal calculi or hypercalcemia (>10mg/dl), current and chronic use of oral corticosteroids; history of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, Crohn disease, or tropical sprue) history of small intestinal resection > 50% (e.g., ileal bypass surgery for treatment of morbid obesity) hypersensitivity to cholecalciferol or one of its components pre-existing parathyroid conditions (including hyperparathyroidism), sarcoidosis chronic liver disease, chronic renal disease, or renal dialysis history of parathyroid disease pregnancy or breast feeding or planning on becoming pregnant chronic alcoholism any medical condition that in the physician?s opinion would potentially interfere with vitamin D absorption, such as celiac sprue, ulcerative colitis, Crohn disease, patients treated pharmacologically for obesity; logistic problems that do not allow follow-up of the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the effect of Vitamin D supplementation (100.000 IU/ml every 50 days vs placebo) on Disease Free Survival (DFS) for resected stage II melanoma patients.;Secondary Objective: to verify whether Vitamin D3 receptors polymorphisms and serum level of 25(OH)D are associated to melanoma prognostic factors; to evaluate vitamin D biology and metabolisms, investigating changes in 25(OH)D by genetic variants and PTH; to evaluate the association between 25(OH)D serum levels and anthropometric measures (such as BMI, waist-to-hip ratio, waist-to-stature ratio), dietary intakes (vitamin D, calcium and fat intake), occupation and different patterns of sun exposures; to determine the percentages of patients who will reach, during the first year of treatment, the desired serum level of 25(OH)D and mean time to reach that level (30 ng/ml); to evaluate safety and toxicity in this cohort of patients; to evaluate compliance with a dose given every 50 days po; to develop a biorepository of blood samples, collected at several time points. This will create a large biological database for future research (e.g., molecular characteristics of intervention effica;Primary end point(s): Disease free survival | — |
Countries
Italy
Outcome results
None listed