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Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma

Primary Purpose

Choroidal Melanoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ranibizumab
Sponsored by
Massachusetts Eye and Ear Infirmary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Choroidal Melanoma focused on measuring glaucoma, neovascular, macular edema, eye enucleation, antibodies, monoclonal, radiation oncology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Massachusetts Eye & Ear Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1.0 mg ranibizumab

0.5 mg ranibizumab

Arm Description

1.0 mg intravitreal injection given bi-monthly for 22 months

0.5 mg intravitreal injection given bi-monthly for 22 months

Outcomes

Primary Outcome Measures

incidence and severity of ocular adverse events and systemic adverse events

Secondary Outcome Measures

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

Full Information

First Posted
October 2, 2008
Last Updated
December 1, 2016
Sponsor
Massachusetts Eye and Ear Infirmary
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00765921
Brief Title
Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma
Official Title
A Phase I Single Center Study of Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Massachusetts Eye and Ear Infirmary
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choroidal Melanoma
Keywords
glaucoma, neovascular, macular edema, eye enucleation, antibodies, monoclonal, radiation oncology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1.0 mg ranibizumab
Arm Type
Experimental
Arm Description
1.0 mg intravitreal injection given bi-monthly for 22 months
Arm Title
0.5 mg ranibizumab
Arm Type
Experimental
Arm Description
0.5 mg intravitreal injection given bi-monthly for 22 months
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
rhuFab, Lucentis
Intervention Description
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).
Primary Outcome Measure Information:
Title
incidence and severity of ocular adverse events and systemic adverse events
Time Frame
12 months and 24 months after initial treatment
Secondary Outcome Measure Information:
Title
incidence of radiation-induced complications, vision loss and eye loss
Time Frame
12 months and 24 months after initial treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivana Kim, M.D.
Organizational Affiliation
Massachusetts Eye and Ear Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts Eye & Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma

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