Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma

NCT00765921 | Completed Phase 1

• 2 other identifiers: 07-06-040FVF4384s
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to investigate the safety and tolerability of the anti-VEGF (vascular endothelial cell growth factor) treatment, ranibizumab, in combination with proton beam irradiation for the treatment of choroidal melanoma by determining the incidence and severity of ocular adverse events. Systemic adverse events will also be evaluated. A secondary objective is to assess the efficacy of ranibizumab in reducing ocular complications that can occur after irradiation.

Conditions

Choroidal Melanoma

Keywords

glaucoma, neovascular; macular edema; eye enucleation; antibodies, monoclonal; radiation oncology

Outcome Measures

Primary Outcomes (1)

• incidence and severity of ocular adverse events and systemic adverse events

  12 months and 24 months after initial treatment

Secondary Outcomes (1)

• incidence of radiation-induced complications, vision loss and eye loss

  12 months and 24 months after initial treatment

Study Arms (2)

1.0 mg ranibizumab

EXPERIMENTAL

1.0 mg intravitreal injection given bi-monthly for 22 months

Drug: ranibizumab

0.5 mg ranibizumab

EXPERIMENTAL

0.5 mg intravitreal injection given bi-monthly for 22 months

Drug: ranibizumab

Interventions

ranibizumab DRUG

Ranibizumab dose of 0.5mg or 1.0 mg will be administered intravitreally at the time of surgery for tumor localization and then bimonthly for 22 months (total of 12 injections).

Also known as: rhuFab, Lucentis

0.5 mg ranibizumab; 1.0 mg ranibizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with newly diagnosed choroidal melanoma undergoing proton therapy
• Tumors \>15 mm in largest diameter and/or \>5 mm in height
• Tumors ≤ 15 mm in largest diameter and ≤ 5 mm in height located ≤ 3 mm from optic disc and/or macula, with best-corrected visual acuity 20/100 or better in study eye

You may not qualify if:

• History of prior treatment for choroidal melanoma
• Pregnancy or lactation
• Presence of diabetic retinopathy
• History of retinal vascular occlusion or other retinal vascular disease
• Active ocular inflammation or history of uveitis in either eye
• History of uncontrolled glaucoma (defined as intraocular pressure \>30mmHg despite treatment with anti-glaucoma medication) or filtering surgery in the study eye
• Previous intravitreal injections of Avastin® in the study eye or in the non-study eye within 30 days.
• Concurrent use of systemic anti-VEGF therapy

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Massachusetts Eye & Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Uveal Melanoma; Glaucoma, Neovascular; Macular Edema

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases; Glaucoma; Ocular Hypertension; Macular Degeneration; Retinal Degeneration; Retinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ivana Kim, M.D.

  Massachusetts Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2008
• First Posted: October 3, 2008
• Study Start: June 1, 2008
• Primary Completion: February 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 2, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)