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Alkylating agents

Melphalan for Retinoblastoma

Phase 1
Waitlist Available
Led By Murali Chintagumpala
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing a new way to give chemotherapy to children with retinoblastoma in one eye that has spread to the inside of the eye. This new method may help kids avoid surgery and reduce side effects.

Eligible Conditions
  • Unilateral Retinoblastoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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
Number of Patients Experiencing Feasibility Failure
Secondary outcome measures
Incidence of Grade 3 or Higher CTCAE Adverse Events Associated With Multiple Doses of IA Chemotherapy
Probability of Ocular Salvage
Rate of Metastases of Retinoblastoma
+1 more

Side effects data

From 2021 Phase 3 trial • 30 Patients • NCT01877837
36%
Infection (grade 3 and above)
24%
Graft versus host disease
8%
Renal insufficiency
4%
SupraVentricular Tachycardia
4%
Alerted mental status
4%
Posterior Reversible Encephalopathy Syndrome
4%
Gastrointestinal bleed
4%
Respiratory failure
4%
Hypokalemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Patients With Sickle Cell Anemia

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (melphalan)Experimental Treatment1 Intervention
Patients receive melphalan IA on day 1. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melphalan
2008
Completed Phase 3
~1500

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,655 Previous Clinical Trials
40,933,205 Total Patients Enrolled
23 Trials studying Retinoblastoma
11,655 Patients Enrolled for Retinoblastoma
Children's Oncology GroupLead Sponsor
453 Previous Clinical Trials
237,686 Total Patients Enrolled
8 Trials studying Retinoblastoma
946 Patients Enrolled for Retinoblastoma
Murali ChintagumpalaPrincipal InvestigatorChildren's Oncology Group

Media Library

Melphalan (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02097134 — Phase 1
Retinoblastoma Research Study Groups: Treatment (melphalan)
Retinoblastoma Clinical Trial 2023: Melphalan Highlights & Side Effects. Trial Name: NCT02097134 — Phase 1
Melphalan (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02097134 — Phase 1

Frequently Asked Questions

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

How many centers are currently hosting the research project?

"This clinical trial is running at 12 distinct medical centres, comprising of Boston, New Haven and San Francisco. To reduce travel needed for participation in the study, it is recommended to select a site near your current location."

Answered by AI

What health conditions typically warrant a prescription of Melphalan?

"Melphalan is traditionally used to treat malignant effusion, however it can be a viable course of action for combating mycosis fungoides (mf), chronic lymphocytic leukemia (CLL), and Stage I Mycosis Fungoides."

Answered by AI

Are investigators presently recruiting participants for this research?

"This clinical trial is not currently accepting participants. It was first posted on April 16th 2014 with the last update occurring on May 19th 2022. If you are looking for alternatives, there are 28 studies involving retinoblastoma and 32 trials administering Melphalan that are actively recruiting volunteers."

Answered by AI

What is the total participant pool for this research endeavor?

"This research has concluded its patient recruitment. The posting was first published on April 16th, 2014 and the last update was made in May 19th, 2022. There are currently 28 studies researching retinoblastoma with open enrollment and 32 trials involving Melphalan welcoming participants."

Answered by AI

Could you expound on the research conducted regarding Melphalan?

"Melphalan was first researched at Providence Medical Center in 2004. Since then, 130 clinical trials have been run their conclusion and 32 are currently active across multiple sites within the state of Massachusetts, notably Boston."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Intra-arterial Melphalan in Treating Younger Patients With Unilateral Retinoblastoma
2014. "Intra-arterial Melphalan in Treating Younger Patients With Unilateral Retinoblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02097134.
~1 spots leftby Apr 2025
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