Topotecan Episcleral Plaque for Treatment of Retinoblastoma (STEP-RB)
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|ClinicalTrials.gov Identifier: NCT04428879|
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : June 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Retinoblastoma||Drug: Topotecan Episcleral Plaque||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Sustained-Release Topotecan Episcleral Plaque (Chemoplaque) for Retinoblastoma|
|Estimated Study Start Date :||June 15, 2020|
|Estimated Primary Completion Date :||October 15, 2025|
|Estimated Study Completion Date :||October 15, 2030|
|Experimental: Phase I single arm trial||
Drug: Topotecan Episcleral Plaque
Sustained Release Episcleral Topotecan Plaques (Chemoplaques) are glued to bare, dry sclera of the eye under conjunctiva and Tenon's capsule. A rolling six dose interpatient escalation schema will be employed. Chemoplaques with 0.6 mg and 0.9 mg of topotecan HCl formulation are available. Patients will receive 1 or 2 Chemoplaques per eye, to deliver 5 escalating doses: 0.6, 0.9, 1.2 [2x0.6], 1.5 [0.6+0.9] or 1.8 [2x0.9] mg. The prescribed dose will escalate or de-escalate by 0.3 mg at each level, and no patient will receive more than 1.8 mg of topotecan hydrochloride due to the physical limitations if the devices available. The planned removal is 42 days ± 7, unless dose limiting toxicity is observed, in which case the plaque is removed as soon as possible. The observation period for the purposes of dose-escalation will be 63 days (i.e. 21 days following Chemoplaque removal on day 42).
- Maximum Tolerated Dose and Recommended Phase 2 Dose of topotecan hydrochloride administered as a Chemoplaque to pediatric patients with active Retinoblastoma. [ Time Frame: 9 weeks ]Inter-Patient Escalation in the rolling six phase 1 trial design will determine Maximum Tolerated Dose and Recommended Phase 2 Dose. Dose level assignment is based on the number of participants currently enrolled in the cohort, the number of dose limiting toxicities observed, and the number of participants at risk for developing a dose limiting toxicity (i.e., participants enrolled but who are not yet assessable for toxicity).
- Tumor response to the Chemoplaque as secondary therapy in eye(s) with active retinoblastoma after completion of primary standard of care treatment. [ Time Frame: 9 weeks ]Tumor response will be characterized as (i) complete regression, (ii) very good (iii) partial regression, (iv) partial regression, (v) stable disease or (vi) progressive disease determined by evaluating number of tumour sites, appearance and tumour size.
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): NCT04428879
|Contact: Kaitlyn Flegg||416-813-7654 ext firstname.lastname@example.org|
|Contact: Entela Zaffino||416-813-7654 ext email@example.com|
|The Hospital for Sick Children||Recruiting|
|Toronto, Ontario, Canada, M5G1X8|
|Contact: Brenda Gallie, MD, FRCSC|
|Principal Investigator:||Brenda Gallie||The Hospital for Sick Children|