Topotecan Episcleral Plaque for Retinoblastoma
(STEP-RB Trial)

Recruiting in Palo Alto (17 mi)

Overseen byBrenda Gallie

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: The Hospital for Sick Children

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new treatment for children with eye cancer that hasn't fully responded to other treatments. It uses a small device placed on the eye to slowly release a cancer-fighting drug directly where it's needed.

Research Team

Brenda Gallie

Principal Investigator

The Hospital for Sick Children

Eligibility Criteria

Children under 18 with active residual or recurrent retinoblastoma in one eye after first-line therapy, or those newly diagnosed with certain types of retinoblastoma without prior treatment. They must have good organ function and performance status, and girls able to have children must use effective birth control. Kids can't join if they have cancer spread outside the eye, allergies to topotecan, other treatments within 3 weeks before the trial starts, uncontrolled illnesses, or are pregnant/breastfeeding.

Inclusion Criteria

My study eye can potentially see and doesn't show signs of cancer spreading outside the eye.

My kidneys are working well.

My blood tests show my bone marrow and platelets are functioning well.

See 7 more

Exclusion Criteria

I am allergic to topotecan, camptothecin, or similar drugs.

I am not pregnant and will stop breastfeeding to start the treatment.

I haven't had chemotherapy or other specific treatments for retinoblastoma within the last 3 weeks.

See 5 more

Treatment Details

Interventions

Topotecan Episcleral Plaque (Topoisomerase I inhibitor)

Trial OverviewThe safety and effectiveness of a new treatment called Topotecan Episcleral Plaque is being tested for kids with a type of eye cancer called retinoblastoma. This study involves gradually increasing doses to find out how much medicine can be given safely while checking how well it works against the cancer.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Phase I single arm trialExperimental Treatment1 Intervention