eoadjuvant intraviTreal ranibizumab treatment in high-risk ocular melanoma patients

Phase 2

• Conditions: Topic: National Cancer Research Network; Subtopic: Melanoma; Disease: Melanoma; Cancer; Malignant neoplasm of eye and adnexa

• Registration Number: ISRCTN35236442
• Lead Sponsor: Royal Liverpool and Broadgreen University Hospitals NHS Trust (UK)

Brief Summary

2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31425478 results (added 07/11/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-16
• Study Completion: 2013-08-01
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

1. Confirmed diagnosis of uveal melanoma requiring enucleation
2. Must have ultrasonographically documented measurable disease within 4 weeks of treatment according to the WHO criteria
3. Prior treatments with chemotherapeutic or antiangiogenic agents for other malignancies are allowed after 6 months of discontinuation
4. Age >=18 years
5. Eastern Cooperative Oncology Group (ECOG) Performance Status = 2
6. Platelets =100,000mm3
7. White cell count (WCC) = 3.0 x 109/L
8. Absolute neutrophil count (ANC) = 1.0 x 109/L
9. Bilirubin < twice normal, Alkaline Phosphatase < 5 x normal
10. International Normalized Ratio (INR) < 2
11. Cr =1.5 ULN
12. Normal blood pressure or controlled hypertension
13. No recent major surgical procedures (laparotomy or thoracotomy) within 4weeks
14. No thromboembolic event within 6 months
15. No known coagulopathy disorder
16. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and followup
schedule; those conditions should be discussed with the patient before registration in the trial
17. Before patient registration, written informed consent must be given according to ICH/GCP, and national regulations
18. Previous or present vascular intraocular diseases not requiring use of antiangiogenic agents will be allowed
19. Hb = 10g/dl

Exclusion Criteria

1. Serious underlying medical condition according to the judgement of the Principal Investigator
2. Pregnant or nursing patients
3. Inability to provide adequate informed consent
4. Hypersensitivity to the active substance or to any of the excipients
5. Active or suspected ocular or periocular infections
6. Active severe intraocular inflammation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response Rate; Timepoint(s): Response will be measured per patient every 28 days after treatment. Maximum of 6 treatments.

Secondary Outcome Measures

Name	Time	Method
To explore relationships between ultrasonographic response, serum and intravitreous VEGF levels