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NCT01783535 · ClinicalTrials.gov registry record · Phase 2
Protocol for the Study and Treatment of Participants With Intraocular Retinoblastoma
A Phase 2 study of Retinoblastoma, sponsored by St. Jude Children's Research Hospital.
- Active
- Registry status
- Phase 2
- Development phase
- 174
- Enrollment target
- 1
- Study location
NCT01783535 is a Phase 2 study of Retinoblastoma that is active but no longer recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 174 participants, below the 581-participant average among 15 other Retinoblastoma trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01783535, a Phase 2 study of Retinoblastoma, is active but no longer recruiting, sponsored by St. Jude Children's Research Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 174 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of this protocol is to evaluate the response rate of bilateral disease participants who have at least one eye with advanced intra-ocular retinoblastoma (stratum B) using upfront therapy with chemotherapy delivered directly to the eye. The main biology objective is to improve our understanding of the biology and tumorigenesis (how tumor develops) of retinoblastoma when biology specimens are available. As clinicians, the primary goal of the investigators for children with retinoblastoma is to provide optimal therapy using multiple treatment approaches \[chemotherapy (into the vein and directly into membrane of eyeball), cryotherapy (freeze and destroy tumor), thermotherapy (laser or heat to destroy tumor), radiation therapy, and surgical removal of eye if needed) in an attempt to preserve the eye and vision whenever possible, while still curing the disease. Therefore, all children with non-metastatic retinoblastoma at St. Jude will be offered enrollment on this study. PRIMARY OBJECTIVE: * To evaluate the response (complete + partial response) rate of bilateral disease participants who have at least one eye with advanced intraocular retinoblastoma (Stratum B) to two upfront courses of therapy consisting of subconjunctival carboplatin and systemic topotecan. SECONDARY OBJECTIVES: * To evaluate the ocular survival of eyes and event-free survival of participants by strata. * To prospectively analyze intraocular disease tissue for participants with at least one eye undergoing enucleation in order to identify the mechanism of RB1 bi-allelic inactivation. Participants may undergo upfront enucleation (due to advanced disease at diagnosis) or may receive enucleation due to progressive disease during protocol therapy.
Conditions Studied
Interventions
- DRUG carboplatin
- DRUG topotecan
- DRUG vincristine
- DRUG filgrastim
- DRUG PEG-filgrastim
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 174 participants |
| Start Date | 2013-06-19 |
| Est. Completion | 2028-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01783535
The ClinicalTrials.gov registry entry for NCT01783535 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 174 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 581-participant average among 15 other Retinoblastoma trials with a reported enrollment target (70% lower). The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Retinoblastoma appearing as the primary indexed condition, and to 5 interventions - of which carboplatin is the first listed.
NCT01783535 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT01783535 about?
NCT01783535 is a clinical study titled "Protocol for the Study and Treatment of Participants With Intraocular Retinoblastoma". The primary objective of this protocol is to evaluate the response rate of bilateral disease participants who have at least one eye with advanced intra-ocular retinoblastoma (stratum B) using upfront therapy with chemotherapy delivered directly to the eye. The main biology objective is to improve ou...
What is the current status of trial NCT01783535?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 174 participants. The study started on 2013-06-19. Estimated completion is 2028-01.
What conditions does trial NCT01783535 study?
This clinical trial studies the following conditions: Retinoblastoma.
What interventions are being tested in trial NCT01783535?
The interventions under investigation include: carboplatin (DRUG), topotecan (DRUG), vincristine (DRUG), filgrastim (DRUG), PEG-filgrastim (DRUG).
Who is sponsoring clinical trial NCT01783535?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01783535 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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