VMCL Melanoma Vaccine Treatment Phase II Study for Therapy of Patients with Advanced Stage IV Melanoma

Phase 1

Active, not recruiting

• Conditions: Advanced Stage IV Melanoma; Cancer - Malignant melanoma

• Registration Number: ACTRN12605000425695
• Lead Sponsor: Royal Adelaide Hospital/University of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Stage IV advanced melanoma with soft tissue/organ metastases; Absence of Brain Metastases; Absence of ocular melanoma associated retinopathy /iritis; Willingness to attend all scheduled clinical visits, tests and blood sampling.

Exclusion Criteria

Solitary bone metastases; Large volume metastatic disease; Poor performance status; Pregnancy; Other malignancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy, measured by performance status (ECOG score).[Evaluated at regular time-points according to the schedule of clinical visits initially 2-weekly, then monthly, then 3-monthly.];Overall survival, measured by performance status (ECOG score).[Evaluated at regular time-points according to the schedule of clinical visits initially 2-weekly, then monthly, then 3-monthly.]

Secondary Outcome Measures

Name	Time	Method
A range of immunological measures that will be correlated with clinical outcome. The aim is to determine any associations between clinical responses and immunological parameters, in order to better predict who might respond to VMCL therapy.[These will be evaluated at regular time-points according to the schedule of clinical visits and blood tests initially 2-weekly, then monthly, then 3-monthly. A further aim is to design better therapy.]