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Alkylating agents

Intraocular Chemotherapy for Retinoblastoma

Phase 2

Recruiting

Led By Rachel C Brennan

Research Sponsored by Children's Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial tests the safety of adding a drug (melphalan) to standard chemotherapy to treat retinoblastoma (a type of cancer of the eye). It may help treat harder-to-treat cases and improve the ability to treat vitreous seeds.

Who is the study for?

This trial is for children under 18 with newly diagnosed retinoblastoma, a cancer of the retina. It's specifically for those with certain types of tumor spread within the eye but no cancer outside it. Kids must have good performance status and adequate organ function, as measured by blood counts and liver/kidney tests.Check my eligibility

What is being tested?

The study is testing if injecting melphalan into the eye, along with standard chemo drugs like carboplatin, vincristine, and etoposide can better treat retinoblastoma. The focus is on improving treatment for tumors that have spread to the vitreous humor (the jelly-like fluid inside the eye).See study design

What are the potential side effects?

Possible side effects include damage to healthy cells in the eye leading to vision problems or loss, general chemotherapy side effects like nausea, hair loss, fatigue, increased risk of infections due to low blood cell counts, and potential kidney or liver issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility success rate of intravitreal melphalan injection in combination with systemic chemotherapy

Secondary outcome measures

Event-free survival (EFS)

Percentage of patients with grade 3 or higher toxicities

Other outcome measures

Highly-recurrent RB somatic copy number alterations (SCNAs) tumor fraction

Long-term visual potential

Proportion of enucleated eyes with particular histopathological characteristics that are known or suspected to affect prognosis adversely

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (CVE, melphalan)Experimental Treatment7 Interventions

See Detailed Description

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1730

Vincristine

2003

Completed Phase 4

~2910

Etoposide

2010

Completed Phase 3

~2440

Melphalan

2008

Completed Phase 3

~1500

Carboplatin

2014

Completed Phase 3

~6670

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor

454 Previous Clinical Trials

237,912 Total Patients Enrolled

8 Trials studying Retinoblastoma

932 Patients Enrolled for Retinoblastoma

Rachel C BrennanPrincipal InvestigatorChildren's Oncology Group

Rachana ShahPrincipal InvestigatorChildren's Oncology Group

Media Library

Melphalan (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05504291 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the combination of CVE and melphalan been approved by regulatory bodies?

"As the trial has only reached Phase 2, our team at Power considers Treatment (CVE and Melphalan) to be of moderate safety, earning it a score of 2. Safety data is present but efficacy still needs to be established."

Answered by AI

How many people are enrolled in this experiment?

"Affirmative. The information found on clinicaltrials.gov reveals that this research is actively enrolling participants, having first been posted on October 19th 2022 and last updated November 28th 2022. 28 individuals have to be recruited from 2 medical facilities for the study’s completion."

Answered by AI

Are there still openings for participation in this clinical trial?

"Affirmative. The information located on clinicaltrials.gov reveals that this study is recruiting patients, having been posted to the website on October 19th 2022 and last updated November 28th 2022. In total, 2 medical sites are attempting to recruit a combined 28 participants for the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Give Treatment Inside the Eye to Treat Retinoblastoma

2022. "A Study to Give Treatment Inside the Eye to Treat Retinoblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05504291.

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