Systemic Vincristine, Carboplatin, and Etoposide, Subtenon Carboplatin, and Local Ophthalmic Therapy in Treating Children With Intraocular Retinoblastoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00072384|
Recruitment Status : Completed
First Posted : November 6, 2003
Last Update Posted : June 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|Intraocular Retinoblastoma||Drug: liposomal vincristine sulfate Procedure: cryosurgery Procedure: laser surgery Drug: carboplatin Drug: etoposide Biological: filgrastim||Phase 3|
I. Determine the event-free survival at 12 months of pediatric patients' eyes with group D intraocular retinoblastoma treated with systemic chemotherapy comprising vincristine, carboplatin, and etoposide, subtenon carboplatin, and local ophthalmic therapy. (Event defined for each eye individually as needed for nonprotocol therapy including nonprotocol chemotherapy, enucleation or any external-beam radiation)
I. Determine the event-free survival at 12 months of pediatric patients' eyes with group C retinoblastoma treated with systemic chemotherapy comprising carboplatin, etoposide, vincristine, subtenon carboplatin, and local ophthalmic therapy.
II. Determine the acute and long-term toxic effects of these regimens in these patients, including visual outcome and incidence of secondary malignancies.
III. Determine the patterns of failure in patients treated with these regimens, in terms of vitreous vs retinal vs both as sites of recurrence.
IV. Determine predictors of failure including findings at the on study examination under anesthesia and response status after six courses of chemotherapy.
V. Determine the percentage of group C and D eyes separately that can be preserved without enucleation after failing protocol therapy.
OUTLINE: This is a multicenter study.
Patients receive vincristine IV over 1 minute on day 1 and carboplatin IV over 1 hour and etoposide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 3 and continuing until blood counts recover. Patients receive subtenon carboplatin to each group C or D eye on day 0 or 1 prior of courses 2-4 only. Treatment repeats every 28 days for 6 courses in the absence of occurrence of extraocular retinoblastoma or a second malignancy. Beginning with course 3 of systemic chemotherapy, patients undergo local ophthalmic therapy comprising local laser and/or cryotherapy on day 1.
Patients are followed with ophthalmology exams every 4-12 weeks until 3 years of age, every 6 months until 5 years of age, and then annually for up to 10 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm Trial of Systemic And Subtenon Chemotherapy For Groups C And D Intraocular Retinoblastoma|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||February 2013|
Experimental: Treatment (chemotherapy, surgery)
Patients receive liposomal vincristine sulfate IV over 1 minute on day 1 and carboplatin IV over 1 hour and etoposide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 3 and continuing until blood counts recover. Patients receive subtenon carboplatin to each group C or D eye on day 0 or 1prior of courses 2-4 only. Treatment repeats every 28 days for 6 courses in the absence of occurrence of extraocular retinoblastoma or a second malignancy. Beginning with course 3 of systemic chemotherapy, patients undergo local ophthalmic therapy comprising local laser surgery and/or cryosurgery on day 1.
Drug: liposomal vincristine sulfate
Application of extreme cold to destroy abnormal or diseased tissue.
Procedure: laser surgery
Surgery using a laser (instead of a scalpel) to cut tissue
- Proportion of failure-free survival of patients with group C and/or D retinoblastoma [ Time Frame: At 1 year ]The observed failure proportion for group D eyes will be compared to the historical proportion of 0.70 using a method suggested by Rosner. The proportion of group C eyes that fail will be compared to the historical probability of 0.40 using the same method.
- Failure-free survival rate [ Time Frame: At 1 year ]Patient-level analyses will be performed using the Kaplan-Meier method to summarize the patient-level failure-free survival experience and the method suggested by Woolson 14 for comparisons to an historical control patient-level failure-free survival rate, where a failure is defined as the need for non-protocol therapy for either eye of a patient, the development of a second malignancy, and/or metastatic disease.
- Acute and long-term toxicities as assessed by Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 10 years ]The occurrence of acute and long-term toxicities will be descriptively summarized.
- Patterns of failure for group C and group D in terms of vitreous vs retinal vs both as sites of recurrence [ Time Frame: At 1 year ]The patterns of failure for group C and group D eyes will be descriptively summarized. The type of therapy given to failing eyes at the time of protocol failure and the use of enucleation at any point after protocol failure will be descriptively summarized. The association between the probability of eye failure at 12 months and eye characteristics including findings at the on study EUA and response status after 6 cycles will be analyzed using generalized estimating equations to account for the paired eyes within patients with bilateral disease.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00072384
|United States, California|
|Children's Oncology Group|
|Arcadia, California, United States, 91006-3776|
|Southern California Permanente Medical Group|
|Downey, California, United States, 90242|
|Children's Hospital Los Angeles|
|Los Angeles, California, United States, 90027|
|United States, Connecticut|
|New Haven, Connecticut, United States, 06520-8032|
|United States, District of Columbia|
|Lombardi Comprehensive Cancer Center at Georgetown University|
|Washington, District of Columbia, United States, 20057|
|United States, Georgia|
|Children's Healthcare of Atlanta - Egleston|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|University of Illinois|
|Chicago, Illinois, United States, 60612|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Rima Jubran||Children's Oncology Group|