NCT00079417

Neoadjuvant Carboplatin and Vincristine and Standard Local Ophthalmic Therapy in Treating Patients With Intraocular Retinoblastoma

Trial of Systemic Neoadjuvant Chemotherapy for Group B Intraocular Retinoblastoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

This phase III trial is studying how well giving carboplatin and vincristine together with standard local ophthalmic therapy works in treating children with intraocular retinoblastoma. Drugs used in chemotherapy, such as carboplatin and vincristine, work in different ways to stop tumor from dividing so they stop growing or die. It is not yet known whether neoadjuvant chemotherapy combined with standard local ophthalmic therapy is effective in treating intraocular retinoblastoma.

Detailed description

PRIMARY OBJECTIVES: I. Determine the 2-year event-free survival of patients with Group B intraocular retinoblastoma treated with neoadjuvant chemoreduction comprising carboplatin and vincristine and standardized local ophthalmic therapy. SECONDARY OBJECTIVES: I. Determine the response rate after one course of chemoreduction (before standardized local ophthalmic therapy) in these patients. II. Correlate response rate with event-free survival in patients treated with this regimen. III. Determine the incidence of toxic effects in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive chemoreduction comprising carboplatin IV over 60 minutes followed by vincristine IV over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local laser therapy, cryotherapy, and/or radioactive plaque comprising iodine I 125 or ruthenium Ru 106. Patients are followed every 3-4 weeks until there is no active tumor seen on a minimum of 3 ophthalmic exams under anesthesia, every 6-8 weeks until 3 years of age, every 4-6 months until 10 years of age, and then annually thereafter.

Conditions

• Intraocular Retinoblastoma

Interventions

Type	Name	Description
DRUG	Carboplatin	Given IV
PROCEDURE	Cryosurgery
PROCEDURE	Infrared Laser Therapy
RADIATION	Iodine I-125	Undergo radioactive therapy
RADIATION	Radiation Therapy	Undergo radioactive therapy
RADIATION	Ruthenium Ru-106	Undergo radioactive therapy
DRUG	Vincristine Sulfate	Given IV

Timeline

• Start date: 2005-12-26
• Primary completion: 2010-01-01
• Completion: 2017-03-31
• First posted: 2004-03-10
• Last updated: 2023-03-13
• Results posted: 2014-02-14

Locations

10 sites across 1 country: United States