MelaViD: A Trial on Vitamin D Supplementation for Resected Stage II Melanoma Patients

NCT01264874 | Terminated Phase 3

• 2 other identifiers: S480/2092009-012049-46
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to assess the effect of vitamin D supplementation on recurrence in resected stage II melanoma patients.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• Disease free survival and Overall Survival

  Disease free survival (DFS) will be the primary end-point of efficacy in this Phase III trial. It will be measured from the date of randomization to the date of progression or death, whatever the cause. Overall Survival will be also evaluated and it is defined as the time from the date of randomization to the date of death from any cause or to the date of last follow-up.

  3 years of treatment and 2 of follow up

Secondary Outcomes (1)

• Evaluation of Vitamin D receptors and 25(OH)D by Breslow thickness.

  baseline and after 1 year of treatment

Study Arms (2)

Vitamin D3

EXPERIMENTAL

Vitamin D3 administration

Drug: Vitamin D3 ( Colecalciferol)

placebo

PLACEBO COMPARATOR

matched placebo

Other: placebo

Interventions

Vitamin D3 ( Colecalciferol) DRUG

100000 IU every 50 days for 3 years

Also known as: dibase

Vitamin D3

placebo OTHER

For 3 years IU every 50 days

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old 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
• 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 within the normal range of each laboratory
• Serum and urinary calcium within the upper limit of laboratory references.

You may not qualify if:

• Primary not cutaneous melanoma
• Clinical/radiological evidence or laboratory/pathology report of not completely resected melanoma
• History of cancer (other than Carcinoma in situ (CIN) and non melanoma skin cancere (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 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 (e.g., ileal bypass surgery for treatment of morbid obesity resection \> 50 % of slim bowel)
• Hypersensitivity to cholecalciferol or one of its components
• Chronic liver disease, chronic renal disease, or renal dialysis
• History of parathyroid disease and sarcoidosis
• Pregnancy or breast feeding or planning on becoming pregnant during the 3 years of treatment
• Chronic alcoholism
• Any medical condition that in the physician's opinion would potentially interfere with vitamin D absorption, such as celiac sprue, ulcerative colitis, patients treated pharmacologically for obesity
• Any logistic condition that do not allow follow-up of the disease of the patient.

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, 20141, Italy

Location

MeSH Terms

Conditions

Melanoma

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Alessandro Testori, MD

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2010
• First Posted: December 22, 2010
• Study Start: May 1, 2010
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: January 31, 2018

Record last verified: 2017-12

Locations

IT (1)