Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00186888
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2005-09-12
Brief Title:
Study of Treatment for Patients With Cancer of the Eye -Retinoblastoma
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
Protocol for the Study and Treatment of Patients With Intraocular Retinoblastoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Retinoblastoma is a childhood cancer which affects the retina of the eye The retina is the light sensitive layer of tissue that lines the back of the eyeball sends visual messages through the optic nerve to the brain When only one eye is affected this is known as unilateral retinoblastoma and when both eyes are affected it is called bilateral retinoblastoma Treatment for retinoblastoma is individualized for each patient and is based on the form and the stage of the disease inside the eye or has moved outside The main goal is always to cure the cancer and save the life of the child Treatments are also designed with the hope of saving the vision while completely destroying the tumor Therapies may involve surgery chemotherapy radiation and other treatments called focal treatments Focal treatments may be laser therapy freezing or heat treatments meant to shrink and kill the tumor
In this study researchers want to investigate how different participants respond to different therapies that are individualized specifically for them Participants will be divided into three main groups depending on whether the disease is unilateral or bilateral and the stage of the disease One of the main objectives of the study is to investigate how advanced tumors in children with bilateral disease respond to a new combination of chemotherapy with topotecan and vincristine with G-CSF support In order to improve results some children with very advanced disease may receive carboplatin chemotherapy given around the eye at the same time that they receive topotecan by vein Also because children with retinoblastoma are diagnosed so early in life and the vision may be significantly impaired this study will investigate how children develop and how the brain adjusts and compensates for the visual deficits Finally this study also investigates the biology of retinoblastoma in order to understand better how this cancer develops
In this study researchers want to investigate how different participants respond to different therapies that are individualized specifically for them Participants will be divided into three main groups depending on whether the disease is unilateral or bilateral and the stage of the disease One of the main objectives of the study is to investigate how advanced tumors in children with bilateral disease respond to a new combination of chemotherapy with topotecan and vincristine with G-CSF support In order to improve results some children with very advanced disease may receive carboplatin chemotherapy given around the eye at the same time that they receive topotecan by vein Also because children with retinoblastoma are diagnosed so early in life and the vision may be significantly impaired this study will investigate how children develop and how the brain adjusts and compensates for the visual deficits Finally this study also investigates the biology of retinoblastoma in order to understand better how this cancer develops
Detailed Description:
This study will determine the following
PRIMARY OBJECTIVE
To estimate the ocular survival and event-free survival of bilateral disease patients with advanced intraocular retinoblastoma in either eye R-E IV-V responding to the vincristinetopotecan window with alternating cycles of vincristine and carboplatin with vincristine topotecan and periocular carboplatin with intensive focal treatments
SECONDARY OBJECTIVES
To estimate the ocular survival of eye and event-free survival of eye of bilateral disease patients with advanced intraocular retinoblastoma in either eye R-E IV-V responding to the vincristinetopotecan window with alternating cycles of vincristine and carboplatin with vincristine topotecan and periocular carboplatin with intensive focal treatments
To estimate the ocular survival and event free survival of patients with advanced intraocular retinoblastoma R-E IV-V not responding to the vincristinetopotecan window with a combination of vincristine carboplatin etoposide and periocular carboplatin with intensive focal treatments
To estimate the ocular survival and event free survival of eye of patients with advanced intraocular retinoblastoma R-E IV-V not responding to the vincristinetopotecan window with a combination of vincristine carboplatin etoposide and periocular carboplatin with intensive focal treatments
To estimate the ocular survival and event-free survival of patients with early stage intraocular retinoblastoma R-E I-III with vincristine and carboplatin with intensive focal treatments
To estimate the ocular survival of eye and event-free survival of eye of patients with early stage intraocular retinoblastoma R-E I-III with vincristine and carboplatin with intensive focal treatments
To estimate the response rate of early stage eyes R-E I-III in patients with contralateral advanced disease treated with vincristine and topotecan
To estimate the ocular survival and event-free survival of early stage eyes R-E I-III of patients with contralateral advanced disease treated with vincristine and topotecan
To describe the outcome of intraocular retinoblastoma with respect to the new International Classification for Intraocular Retinoblastoma and the AJCC
To describe primary visual cortex function in patients with unilateral and bilateral retinoblastoma
To describe the cognitive adaptive and socialemotional development of children with retinoblastoma
To describe changes in the pineal gland during treatment in patients with bilateral retinoblastoma
To assess the relation between CYP3A45 genotype and the pharmacokinetics and pharmacodynamics of topotecan
To assess the relation between ABCG2 genotype and the pharmacokinetics and pharmacodynamics of topotecan
To determine if carboplatin can produce changes in cochlear function that are detectable with measurement of otoacoustic emissions
To evaluate the need for and feasibility of starting early intervention support during the first year after the diagnosis of retinoblastoma
EXPLORATORY OBJECTIVES
To provide insight into molecular pathogenesis of retinoblastoma
To describe the incidence and type of germline mutations of the RB gene in patients with retinoblastoma
PRIMARY OBJECTIVE
To estimate the ocular survival and event-free survival of bilateral disease patients with advanced intraocular retinoblastoma in either eye R-E IV-V responding to the vincristinetopotecan window with alternating cycles of vincristine and carboplatin with vincristine topotecan and periocular carboplatin with intensive focal treatments
SECONDARY OBJECTIVES
To estimate the ocular survival of eye and event-free survival of eye of bilateral disease patients with advanced intraocular retinoblastoma in either eye R-E IV-V responding to the vincristinetopotecan window with alternating cycles of vincristine and carboplatin with vincristine topotecan and periocular carboplatin with intensive focal treatments
To estimate the ocular survival and event free survival of patients with advanced intraocular retinoblastoma R-E IV-V not responding to the vincristinetopotecan window with a combination of vincristine carboplatin etoposide and periocular carboplatin with intensive focal treatments
To estimate the ocular survival and event free survival of eye of patients with advanced intraocular retinoblastoma R-E IV-V not responding to the vincristinetopotecan window with a combination of vincristine carboplatin etoposide and periocular carboplatin with intensive focal treatments
To estimate the ocular survival and event-free survival of patients with early stage intraocular retinoblastoma R-E I-III with vincristine and carboplatin with intensive focal treatments
To estimate the ocular survival of eye and event-free survival of eye of patients with early stage intraocular retinoblastoma R-E I-III with vincristine and carboplatin with intensive focal treatments
To estimate the response rate of early stage eyes R-E I-III in patients with contralateral advanced disease treated with vincristine and topotecan
To estimate the ocular survival and event-free survival of early stage eyes R-E I-III of patients with contralateral advanced disease treated with vincristine and topotecan
To describe the outcome of intraocular retinoblastoma with respect to the new International Classification for Intraocular Retinoblastoma and the AJCC
To describe primary visual cortex function in patients with unilateral and bilateral retinoblastoma
To describe the cognitive adaptive and socialemotional development of children with retinoblastoma
To describe changes in the pineal gland during treatment in patients with bilateral retinoblastoma
To assess the relation between CYP3A45 genotype and the pharmacokinetics and pharmacodynamics of topotecan
To assess the relation between ABCG2 genotype and the pharmacokinetics and pharmacodynamics of topotecan
To determine if carboplatin can produce changes in cochlear function that are detectable with measurement of otoacoustic emissions
To evaluate the need for and feasibility of starting early intervention support during the first year after the diagnosis of retinoblastoma
EXPLORATORY OBJECTIVES
To provide insight into molecular pathogenesis of retinoblastoma
To describe the incidence and type of germline mutations of the RB gene in patients with retinoblastoma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P01CA023099 | NIH | None | None |
| NCI-2011-01186 | REGISTRY | NCI Clinical Trial Registration Program | httpsreporternihgovquickSearchP01CA023099 |