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Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma

This study is currently recruiting participants.
Verified December 2012 by Massachusetts Eye and Ear Infirmary
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT00765921
First received: October 2, 2008
Last updated: December 18, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Choroidal Melanoma
 Drug: ranibizumab
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Phase I Single Center Study of Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Melanoma
Drug Information available for: Ranibizumab
U.S. FDA Resources

Further study details as provided by Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:
  • incidence and severity of ocular adverse events and systemic adverse events [ Time Frame: 12 months and 24 months after initial treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • incidence of radiation-induced complications, vision loss and eye loss [ Time Frame: 12 months and 24 months after initial treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1.0 mg ranibizumab
1.0 mg intravitreal injection given bi-monthly for 22 months
 Drug: ranibizumab
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).
Other Names:
  • rhuFab
  • Lucentis
Experimental: 0.5 mg ranibizumab
0.5 mg intravitreal injection given bi-monthly for 22 months
 Drug: ranibizumab
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).
Other Names:
  • rhuFab
  • Lucentis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with newly diagnosed choroidal melanoma undergoing proton therapy
  • Tumors >15 mm in largest diameter and/or >5 mm in height (recruitment complete)
  • Tumors ≤ 15 mm in largest diameter and ≤ 5 mm in height located ≤ 3 mm from optic disc and/or macula
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765921

Contacts
Contact: Edward Miretsky, B.A. 617-573-4382 edward_miretsky@meei.harvard.edu

Locations
United States, Massachusetts
Massachusetts Eye & Ear Infirmary Recruiting
Boston, Massachusetts, United States, 02114
Contact: Edward Miretsky, B.A.     617-573-4382     edward_miretsky@meei.harvard.edu    
Principal Investigator: Ivana Kim, M.D.            
Sub-Investigator: Evangelos Gragoudas, M.D.            
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Genentech
Investigators
Principal Investigator: Ivana Kim, M.D. Massachusetts Eye and Ear Infirmary
  More Information

No publications provided

Responsible Party: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT00765921     History of Changes
Other Study ID Numbers: 07-06-040, FVF4384s
Study First Received: October 2, 2008
Last Updated: December 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts Eye and Ear Infirmary:
glaucoma, neovascular
macular edema
eye enucleation
antibodies, monoclonal
radiation oncology

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on June 18, 2013