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NCT02097134 · ClinicalTrials.gov registry record · Phase 1
Intra-arterial Melphalan in Treating Younger Patients With Unilateral Retinoblastoma
A Phase 1 study of Unilateral Retinoblastoma, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 12
- Study locations
NCT02097134: Completed Phase 1 study of Unilateral Retinoblastoma, sponsored by Children's Oncology Group.
NCT02097134 is a Phase 1 study of Unilateral Retinoblastoma that has completed, run by Children's Oncology Group. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). The trial reports 12 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02097134, a Phase 1 study of Unilateral Retinoblastoma, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 12
- Study locations
Study Summary
This pilot clinical trial studies whether unilateral group D retinoblastoma, or retinoblastoma affecting one eye that has spread to the inner jelly like part of the eye, can be treated with a new technique for delivering chemotherapy directly into the blood vessel that supplies the affected eye. This new technique is called intra-arterial injection. Giving melphalan via intra-arterial injection may make it less likely that children will need surgery to remove the eye and may reduce the amount of treatment side effects.
Primary Outcome
Feasibility failure is defined as a) interventional radiologist is unable to access the ophthalmic artery for the 1st chemotherapy administration for any reason; b) patient develops central retinal artery occlusion after the 1st or 2nd course that does not reopen by the time the next injection is due; or c) the patient cannot receive all three treatments because of Common Terminology Criteria for Adverse Events (CTCAE) complications grade III or IV that are considered possibly, probably or likel
Conditions Studied
Interventions
- DRUG Melphalan
Study Locations (12)
California
- Children's Hospital Los Angeles - Los Angeles
- UCSF Medical Center-Parnassus - San Francisco
- UCSF Medical Center-Mission Bay - San Francisco
Texas
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center - Houston
- M D Anderson Cancer Center - Houston
Connecticut
- Yale University - New Haven
Florida
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
Georgia
- Children's Healthcare of Atlanta - Egleston - Atlanta
Massachusetts
- Dana-Farber Cancer Institute - Boston
North Carolina
- Duke University Medical Center - Durham
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2014-10-31 |
| Est. Completion | 2023-09-30 |
| Phase | Phase 1 |
What the finished NCT02097134 record still lists
NCT02097134 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Unilateral Retinoblastoma appearing as the primary indexed condition, and to 1 intervention - of which Melphalan is the first listed.
NCT02097134 lists 12 locations in 9 states (California, Texas, Connecticut).
Frequently Asked Questions
What is clinical trial NCT02097134 about?
NCT02097134 is a clinical study titled "Intra-arterial Melphalan in Treating Younger Patients With Unilateral Retinoblastoma". This pilot clinical trial studies whether unilateral group D retinoblastoma, or retinoblastoma affecting one eye that has spread to the inner jelly like part of the eye, can be treated with a new technique for delivering chemotherapy directly into the blood vessel that supplies the affected eye. Thi...
What is the current status of trial NCT02097134?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2014-10-31. Estimated completion is 2023-09-30.
What conditions does trial NCT02097134 study?
This clinical trial studies the following conditions: Unilateral Retinoblastoma.
What interventions are being tested in trial NCT02097134?
The interventions under investigation include: Melphalan (DRUG).
Who is sponsoring clinical trial NCT02097134?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02097134 being conducted?
This trial has 12 study locations across California, Connecticut, Florida, Georgia, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02097134's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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