| Original Study ID : CDR0000355721 |
| Secondary ID : COG-ARET0331 |
| NCT ID : NCT00079417 |
| Brief Title : Neoadjuvant Carboplatin and Vincristine and Standard Local Ophthalmic Therapy in Treating Patients With Intraocular Retinoblastoma |
| Official Title : Trial of Systemic Neoadjuvant Chemotherapy for Group B Intraocular Retinoblastoma |
| Brief Summary : RATIONALE: 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. PURPOSE: 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. |
| Source : National Cancer Institute (NCI) |
| Detailed Description : OBJECTIVES: Primary - 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 - Determine the response rate after one course of chemoreduction (before standardized local ophthalmic therapy) in these patients. - Correlate response rate with event-free survival in patients treated with this regimen. - 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. PROJECTED ACCRUAL: A total of 85 patients will be accrued for this study within 3.5 years. |
| Overall Status : Recruiting |
| Start Date : December 2005 |
| Official Title : Phase 3 |
| Phase : Interventional |
| Study Design : Treatment, Open Label |
| Enrollment : 85 |
| Verification Date : May 2009 |
| First Received Date : March 8, 2004 |
| Trial Eligibility |
| Criteria : DISEASE CHARACTERISTICS: - Newly diagnosed Group B intraocular retinoblastoma meeting 1 of the following criteria: - Group B tumor(s) in 1 eye - Group B tumor(s) in both eyes - Group A tumor in 1 eye and Group B tumor(s) in the other eye - Group E tumor in 1 eye that has been enucleated and Group B tumor(s) in the remaining eye at the time of enucleation of the Group E tumor - Defined by the International Classification System for Intraocular Retinoblastoma as follows: - Group A: Small tumors (≤ 3 mm in greatest dimension) confined to the retina, away from foveola and disc meeting the following criteria: - More than 3 mm from fovea - More than 1.5 mm from optic disk - Group B: Tumors more than 3 mm meeting the following criteria: - Confined to the retina in any location not in Group A - Tumor associated subretinal fluid < 3 mm from the tumor margin with no subretinal seeding - Group E: Must have ≥ 1 of the following present: - Tumor touching the lens - Tumor anterior to anterior vitreous face involving ciliary body or anterior segment - Diffuse infiltrating retinoblastoma - Neovascular glaucoma - Opaque media from hemorrhage - Tumor necrosis with aseptic orbital cellulites - Phthisis bulbi - Confirmation of diagnosis by CT scan or MRI of the brain and orbits AND an ophthalmologic evaluation under anesthesia within the past 3 weeks - No choroidal and/or optic nerve invasion past the lamina cribosa - No evidence of extraocular retinoblastoma clinically or by head and orbital MRI and/or CT scan - No tumor present on histological exam at the cut end of the optic nerve for any Group E eye enucleated before study entry PATIENT CHARACTERISTICS: Age - 5 and under Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age - AST or ALT < 2.5 times ULN for age Renal - Creatinine clearance (based on Schwartz formula) or radioisotope glomerular filtration rate ≥ 70mL/min/1.73 m^2 PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy - No other concurrent radiotherapy, including intensity-modulated stereotactic, or proton beam radiotherapy Surgery - Prior enucleation of one eye allowed provided the remaining eye is Group B - No concurrent enucleation Other - No prior local ophthalmic therapy for retinoblastoma - No other prior therapy for retinoblastoma - No local therapy during chemotherapy course 1 |
| Gender : Both |
| Minimum Age : N/A |
| Maximum Age : 5 Years |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : Childrens Hospital Los Angeles |
| Status : Recruiting |
| City : Los Angeles |
| State : California |
| Zip Code : 90027 |
| Country : United States |
| Facility Name : UCSF Helen Diller Family Comprehensive Cancer Center |
| Status : Recruiting |
| City : San Francisco |
| State : California |
| Zip Code : 94115 |
| Country : United States |
| Facility Name : University of Miami Sylvester Comprehensive Cancer Center - Miami |
| Status : Recruiting |
| City : Miami |
| State : Florida |
| Zip Code : 33136 |
| Country : United States |
| Facility Name : Winship Cancer Institute of Emory University |
| Status : Recruiting |
| City : Atlanta |
| State : Georgia |
| Zip Code : 30322 |
| Country : United States |
| Facility Name : Children's Memorial Hospital - Chicago |
| Status : Recruiting |
| City : Chicago |
| State : Illinois |
| Zip Code : 60614 |
| Country : United States |
| Facility Name : University of Illinois Cancer Center |
| Status : Recruiting |
| City : Chicago |
| State : Illinois |
| Zip Code : 60612-7243 |
| Country : United States |
| Facility Name : Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute |
| Status : Recruiting |
| City : Boston |
| State : Massachusetts |
| Zip Code : 02115 |
| Country : United States |
| Facility Name : Massachusetts General Hospital |
| Status : Recruiting |
| City : Boston |
| State : Massachusetts |
| Zip Code : 02114 |
| Country : United States |
| Facility Name : Barbara Ann Karmanos Cancer Institute |
| Status : Recruiting |
| City : Detroit |
| State : Michigan |
| Zip Code : 48201-1379 |
| Country : United States |
| Facility Name : Duke Comprehensive Cancer Center |
| Status : Recruiting |
| City : Durham |
| State : North Carolina |
| Zip Code : 27710 |
| Country : United States |
| Facility Name : Cincinnati Children's Hospital Medical Center |
| Status : Recruiting |
| City : Cincinnati |
| State : Ohio |
| Zip Code : 45229-3039 |
| Country : United States |
| Facility Name : Children's Hospital of Philadelphia |
| Status : Recruiting |
| City : Philadelphia |
| State : Pennsylvania |
| Zip Code : 19104-9786 |
| Country : United States |
| Facility Name : Baylor University Medical Center - Houston |
| Status : Recruiting |
| City : Houston |
| State : Texas |
| Zip Code : 77030-2399 |
| Country : United States |
| Facility Name : M. D. Anderson Cancer Center at University of Texas |
| Status : Recruiting |
| City : Houston |
| State : Texas |
| Zip Code : 77030-4009 |
| Country : United States |
| Facility Name : Children's Hospital and Regional Medical Center - Seattle |
| Status : Recruiting |
| City : Seattle |
| State : Washington |
| Zip Code : 98105 |
| Country : United States |
| OutComes |
| Primary OutComes |
| Measure : Event-free survival at 2 years |
| Safety issue : No |
| Secondary OutComes |
| Measure : Use of nonprotocol chemotherapy at the patient level |
| Safety issue : No |
| Measure : Enucleation and external beam radiotherapy (EBRT) at the patient and eye levels |
| Safety issue : No |
| Measure : Response rate at patient and eye levels after the first course |
| Safety issue : No |
| Measure : Event-free survival rate |
| Safety issue : No |
| Measure : Toxicity |
| Safety issue : Yes |
| Interventions |
| Type : Drug |
| Name : carboplatin |
| Type : Drug |
| Name : vincristine sulfate |
| Type : Procedure |
| Name : cryosurgery |
| Type : Procedure |
| Name : laser therapy |
| Type : Procedure |
| Name : neoadjuvant therapy |
| Type : Radiation |
| Name : iodine I 125 |
| Type : Radiation |
| Name : ruthenium Ru 106 |
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