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

Phase 2

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Melanoma; Disease: Melanoma; Cancer; Malignant melanoma of skin

• Registration Number: ISRCTN20253034
• Lead Sponsor: Oxford University (UK)

Brief Summary

2016 Results article in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5104891/ results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-17
• Study Completion: 2014-11-28
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

1. More than or equal to 18 years of age, written informed consent
2. Histological confirmation of malignant melanoma
3. Unresectable Stage III or IV metastatic melanoma with brain metastases
4. Karnofsky Performance Score > 70%
5. Radiation Therapy Oncology Group recursive partitioning analysis (RTOG RPA) score 1 or 2
6. Measurable disease as defined by RECIST version 1.1
7. Adequate haematological, hepatic and renal function
8. Adequate cardiac function New York Heart Association (NHYA) 0-1
9. QTc < 480msec
Target Gender: Male & Female ; Lower Age Limit 18 years

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of vandetanib in combination with radiotherapy, compared with radiotherapy; Timepoint(s): Progression free survival in brain (as assessed by MRI scan)

Secondary Outcome Measures

Name	Time	Method
<br> 1. Safety and tolerability of vandetanib in combination with radiotherapy; Timepoint(s): Adverse events using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0<br> 2. Vital signs and weight<br> 3. Biochemistry, haematology<br> 4. Efficacy of vandetanib in combination with radiotherapy, compared with radiotherapy; Timepoint(s): Maintenance of cognitive function (as assessed by Wide Range Achievement Test)<br>