Neoadjuvant Carboplatin and Vincristine and Standard Local Ophthalmic Therapy in Treating Patients With Intraocular Retinoblastoma
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 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.
Procedure: infrared laser therapy
Radiation: iodine I 125
Radiation: ruthenium Ru 106
Drug: vincristine sulfate
Radiation: radiation therapy
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Trial of Systemic Neoadjuvant Chemotherapy for Group B Intraocular Retinoblastoma|
- Event-free survival [ Time Frame: At 2 years ] [ Designated as safety issue: No ]Observed survival experience to the expected distribution using a method adapted from Woolson will be used. The difference between the number of observed and expected failures is approximately normally distributed with independent increments and may be used for interim monitoring using standard group sequential boundaries. Outcome data will be formally reviewed, using the Lan-DeMets α-spending function implementation of sequential boundaries, after every expected failure, corresponding approximately to 33%, 66% and 100% of the expected information.
- Use of nonprotocol chemotherapy [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]Use of nonprotocol chemotherapy at the patient level and enucleation and EBRT will be descriptively summarized at the patient and eye levels.
- Response rate (RR) at patient and eye levels after the first course [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]RR will be estimated. The response after 1 course of chemotherapy will be used to better define response to this neoadjuvant systemic chemotherapy, prior to the use of local ophthalmic therapy. Response to subsequent courses will help define response to combined systemic chemotherapy and local ophthalmic therapy.
- Event-free survival rate (EFSR) defined as the need for non-protocol chemotherapy, enucleation, or EBRT at the patient level [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]EFSR will be estimated for patients who respond to vincristine and carboplatin after an initial 1 cycle of chemoreduction
- Toxicity as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 [ Time Frame: From the beginning of treatment, assessed up to 10 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2005|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Experimental: Vincrisitne Sulfate and Carboplatin and surgery
Patients receive chemoreduction comprising carboplatin IV (Pts < 36 months: 18.6 mg/kg Pts ≥ 36 months: 560 mg/m2) over 60 minutes followed by vincristine sulfate IV (Pts < 36 months: 0.05 mg/kg Pts ≥36 months: 1.5 mg/m2) 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 infrared laser therapy, cryosurgery, and/or radiation therapy (radioactive) plaque comprising iodine I 125 or ruthenium Ru 106.
Application of extreme cold to destroy abnormal or diseased tissue.
Other Names:Procedure: infrared laser therapy
Laser therapy or "photobiomodulation" is the use of specific wavelength of light (red and near-infrared) to create therapeutic effectsRadiation: iodine I 125
Undergo radioactive therapy
Other Names:Radiation: ruthenium Ru 106
Undergo radioactive therapy
Other Names:Drug: carboplatin
Other Names:Drug: vincristine sulfate
Other Names:Radiation: radiation therapy
Undergo radioactive therapy
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.
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.
|United States, California|
|Children's Oncology Group|
|Arcadia, California, United States, 91006-3776|
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Debra Friedman||Children's Oncology Group|