Title

RADVAN

Chief Investigator: 

EudraCT number: 2011-000661-12 
Sponsor: University of Oxford

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, overall survival and safety and tolerability of vandetanib in combination with radiotherapy.

Study Status

Target recruitment: 6 patients in a safety cohort plus 80 patients in the randomised trial.

Current status: Closed to recruitment. All patients are now off trial.

Unfortunately research teams across the country found it more difficult than expected to find patients who are suitable for the study and for whom the trial is the best treatment option for their cancer. After 13 months of recruitment the Trial Steering Committee who oversee the trial reviewed the study’s progress carefully and agreed to close recruitment to the RADVAN trial in April 2014, before the total number of patients needed to finish the study was recruited.

A substantial amendment has been submitted to the ethics committee and regulator to close the study earlier than planned - the trial is now expected to close in December 2014. Follow up of participants in the study will continue as planned under the original study protocol until the study ends.

The researchers intend to publish the study results that we have in a medical journal for other doctors to read so that they can learn from our experience of the study.

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
  • 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.

Data Submission

Data submission for this trial is via electronic submission of data in OpenClinica. 

OpenClinica Training

OpenClinica is the world's leading open source clinical trial software for electronic data capture and clinical data management. 

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