Phase II Study on Chemoplaque Treatment for Advanced Retinoblastoma
Sponsor: Targeted Therapy Technologies, LLC
ClinicalTrials ID:NCT06679634
This clinical trial is exploring a new treatment method using a chemoplaque to help save eyes affected by advanced or returning retinoblastoma, a type of eye cancer in children. The study aims to find the safest and most effective chemotherapy dose for this condition.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study is investigating a new way to treat advanced or recurrent retinoblastoma, a serious eye cancer in children. For cases where the cancer is advanced in one eye or hasn't responded to standard treatments, removing the eye is often considered. This trial will test the use of a chemoplaque, a device that delivers chemotherapy directly to the eye, to see if it can help save the affected eye. The main goal is to determine the safety and effectiveness of this treatment and find the best chemotherapy dose.
Description
In this study, a chemoplaque will be placed on the eye during a procedure under anesthesia. This involves a small surgery where a reservoir that releases chemotherapy medication is placed under the eye's surface lining and attached to the eye's outer coating. The chemoplaque stays on the eye until day 56, when it will be removed. Eye exams under anesthesia will be done on Day 0, Day 28, Day 56 (before removing the chemoplaque), and Day 84 (final visit). Blood tests will be done regularly to check blood health and any side effects of the medication. Participants will be followed until Day 84, when the study treatment is completed.
Eligibility Criteria
Inclusion Criteria
- Children under 8 years old.
- Diagnosed with advanced retinoblastoma in one eye where eye removal is recommended, or cancer that has returned after initial treatment.
- If both eyes need treatment, each will be treated separately. The non-study eye will receive standard care.
- Must show calcium in the tumor-containing eye through ultrasound or imaging.
- The affected eye must have some vision potential and no signs of cancer spreading outside the eye.
- Must meet certain health criteria, including:
- Adequate bone marrow function with specific blood cell counts.
- Adequate kidney function based on age-specific creatinine levels.
- Adequate liver function with specific enzyme and protein levels.
- Females of childbearing potential must use effective birth control during the study and for 40 days after treatment.
- Must be able to understand and sign informed consent, with assent from children when appropriate.
Exclusion Criteria
- Cancer involving the optic nerve or signs of spreading outside the eye.
- Allergy to the study medication or similar drugs.
- Recent chemotherapy or other retinoblastoma treatments within 3 weeks of starting the study treatment.
- Uncontrolled illnesses that could increase risk or affect study participation.
- Significant fever within one week before starting treatment.
- Pregnant or breastfeeding women, as the treatment could affect the baby. A negative pregnancy test is required before starting treatment.
- Any condition that could interfere with following the study instructions or affect the study results.
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.