Topotecan Episcleral Plaque for Retinoblastoma

Recruiting in Palo Alto (17 mi)

+1 other location

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Targeted Therapy Technologies, LLC

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing a new way to treat eye cancer in children using a small device that slowly releases a cancer drug directly onto the eye. It targets kids whose cancer didn't respond to other treatments. The goal is to see if this method is safe and works well without causing too many side effects.

Eligibility Criteria

This trial is for children and young adults under 21 with retinoblastoma in at least one eye, who have completed first-line therapy. They must have potential vision in the affected eye and meet specific health criteria including adequate bone marrow, kidney, and liver function. Females of childbearing age must use effective contraception.

Inclusion Criteria

My bone marrow is working well.

One of my eyes, the one more affected by retinoblastoma or with better vision potential, will be treated in the study.

SGPT (ALT) less than or equal 110 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L.

+26 more

Exclusion Criteria

There is evidence that the cancer has spread beyond the eyes.

I am not pregnant or breastfeeding, or I have stopped breastfeeding to join the study.

My scans show possible or confirmed spread of eye cancer to the optic nerve or beyond.

+8 more

Participant Groups

The safety and effectiveness of a treatment called episcleral topotecan are being tested on patients with active de novo or recurrent intraocular retinoblastoma. It's a phase I trial where doses will be increased to find the safest dose that can also potentially help treat the cancer.

1Treatment groups

Experimental Treatment

Group I: Phase I Open Label StudyExperimental Treatment1 Intervention

Phase I Single Arm

Topotecan is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Hycamtin for: