RADVAN

A randomised double blind phase 2 trial of whole brain radiotherapy with or without vandetanib in metastatic melanoma with brain metastases

The aim is to compare whole brain radiotherapy (WBRT) with or without vandetanib in the treatment of patients with brain metastases from melanoma, in terms of progression free survival, cognitive function, overall survival and safety and tolerability of vandetanib in combination with radiotherapy.

STUDY STATUS

INCLUSION CRITERIA

• ≥ 18 years of age, written informed consent
• Histological confirmation of malignant melanoma
• Unresectable Stage III or IV metastatic melanoma with brain metastases
• Karnofsky Performance Score >70%
• RTOG RPA score 1 or 2
• Measurable disease as defined by RECIST version 1.1
• Adequate haematological, hepatic and renal function
• Adequate cardiac function
  
• QTc <480msec

EXCLUSION CRITERIA

• Radiotherapy or systemic melanoma therapy within 28 days prior to starting treatment.
• Prior whole brain irradiation
• CNS melanoma where all detectable disease has been treated by neurosurgery or stereotactic irradiation
• Presence of leptomeningeal disease
• More than 3 extra-cranial organ sites involved with melanoma
• Pregnancy or breastfeeding women
• Significant cardiovascular disease
• Uncontrolled hypertension
• Serum calcium, magnesium or potassium below the normal range despite supplementation
• Requirement for medication that increases QTc and/or the risk of torsades de point
• Requirement for medication that is a potent inducer of CYP3A4 function
• Ocular malignant melanoma
• Another active malignancy within the past five years
• Any clinically significant and uncontrolled major medical conditions.
• Any condition that would preclude adequate absorption of vandetanib.

OBJECTIVES

Primary:

• To assess the efficacy of vandetanib in combination with radiotherapy, compared with radiotherapy alone, in the treatment of patients with brain metastases from melanoma.

Secondary:

• To assess the safety and tolerability of vandetanib in combination with radiotherapy, compared with radiotherapy alone.

OpenClinica

Data submission for this trial is via electronic submission of data in OpenClinica. OpenClinica is the world's leading open source clinical trial software for electronic data capture and clinical data management.  Information on how to use OpenClinica can be found on the OpenClinica Training page using the link below. It contains a user guide and instructional videos to show you how to use OpenClinica.  After reviewing these if you have any other queries please contact a member of the trial team at OCTO.

 

Oncology Clinical Trials Office (OCTO)

Randomisation Service Mon-Fri 9-5 (UK Time):

UK Tel: 0800 389 1635, UK Fax: 0800 389 1629 (24hrs)

Non UK Tel: +44 (0)1865 617 014, Non UK Fax: +44 (0)1865 617 015 (24hrs)

 

General Enquiries: Tel: +44 (0)1865 617 000, Fax: +44 (0)1865 617 010

Email: RADVAN@octo-oxford.org.uk

Website: www.octo-oxford.org.uk