Retinoblastoma Phase II Expanded Access Clinical Trial

Part of paid clinical trials in New York, New York.

Sponsor
Targeted Therapy Technologies, LLC
Study ID
NCT06679634
Phase
PHASE2
Status
Recruiting
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Conditions

  • Retinoblastoma

Eligibility Criteria

Sex
ALL
Age
N/A - 8 Years
Healthy Volunteers
Not accepted

Interventions

  • Chemoplaque also referred to as Episcleral Topotecan — DRUG
    Sustained Release Episcleral Topotecan

Study Details

In this research study investigators want to learn more about treatment of advanced or recurrent retinoblastoma. For children with retinoblastoma that have an advanced stage of presentation in one eye or if they have failed all conventional treatment, eye removal is considered. This study will investigate the utility of a chemoplaque(s) to salvage eyes involved with retinoblastoma. The goal of the study is to further determine/assess the safety and efficacy and optimal chemotherapy dose for retinoblastoma.

Key Dates

Start date
Feb 21, 2025
Status verified
May 2026
Primary completion
Nov 30, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Chemoplaque
    Chemoplaque (also referred to as Episcleral Topotecan) treatment will involve single application of the Episcleral Topotecan 1.2 mg dose that delivers sustained delivery for 8 weeks.

Primary Outcome Measure

To determine the safety and tolerability of Episcleral Topotecan in participants with retinoblastoma by measuring the rate and severity of treatment related adverse events in study participants as assessed by CTCAE version 5.0 criteria. [ Time Frame: 12 weeks and follow up ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
NewYork Presbyterian Morgan Stanley Children's HospitalNew YorkNew York10032
Brian Marr, MD
610-6594664
Lauren Yeager, MD
847-840-1082
Children's WisconsinMilwaukeeWisconsin53226
Aparna Ramasubramanian, MD
[email protected]
414-266-2020
Kimberly Mayer, RN
[email protected]
414-477-5336
Aparna Ramasubramanian, MD (PRINCIPAL_INVESTIGATOR)

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NewYork Presbyterian Morgan Stanley Children's Hospital· New York, NYChildren's Wisconsin· Milwaukee, WI

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