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Alkylating agents
Intra-arterial Chemotherapy for Retinoblastoma (IAC Trial)
Phase 1
Waitlist Available
Led By Margaret Reynolds, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients whose other treatment options would require systemic chemotherapy, radiotherapy, or enucleation
Patients who have bilateral COG stage B, C, D, or E retinoblastoma who have undergone systemic chemotherapy without resolution and would have specific treatment options remaining
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years post-treatment
Awards & highlights
IAC Trial Summary
This trial is testing a new way to give chemotherapy to children with retinoblastoma, a cancer of the eye. Up to 3 doses of melphalan will be given through a small tube in the artery. Doctors will check if it is safe and effective.
Who is the study for?
This trial is for children over 4 months old with retinoblastoma, a type of eye cancer. It's specifically for those who haven't responded to systemic chemotherapy and are facing limited treatment options like eye removal or radiation. Patients need consent from a parent or guardian. Those with allergies to melphalan, pregnant/breastfeeding individuals, HIV patients with low CD4+ counts or recent opportunistic infections, and cases where the cancer has spread significantly are excluded.Check my eligibility
What is being tested?
The trial tests intra-arterial chemotherapy using melphalan in children with retinoblastoma. Participants will receive up to three doses of this drug directly into the artery supplying the eye tumor. The study aims to evaluate how feasible and toxic this approach is and how well it works in shrinking the tumors.See study design
What are the potential side effects?
Melphalan may cause side effects such as damage to blood cells leading to increased infection risk, bleeding problems, allergic reactions similar to other drugs in its class, nausea, vomiting, mouth sores, and potential impact on fertility later in life.
IAC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My next treatment options include chemotherapy, radiotherapy, or eye removal.
Select...
I have advanced retinoblastoma in both eyes and chemotherapy hasn't worked.
Select...
I have a type of eye cancer in one eye that is not inherited.
Select...
I was diagnosed with retinoblastoma when I was older than 4 months.
IAC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of intra-arterial chemotherapy as measured by the number of participants who receive 3 intra-arterial injections of melphalan
Secondary outcome measures
Rate of metastatic disease
Rate of ocular salvage
Rate of procedure-related complications
+1 moreSide effects data
From 2021 Phase 3 trial • 30 Patients • NCT0187783736%
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
IAC Trial Design
1Treatment groups
Experimental Treatment
Group I: Intra-arterial injections of melphalanExperimental Treatment1 Intervention
-Participants will receive intra-arterial injections of melphalan Q4W for 3 cycles.
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?
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,704 Total Patients Enrolled
1 Trials studying Retinoblastoma
14 Patients Enrolled for Retinoblastoma
Margaret Reynolds, M.D.Principal InvestigatorWashington University School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My next treatment options include chemotherapy, radiotherapy, or eye removal.I do not have any uncontrolled illnesses or heart problems.My child has advanced eye cancer in one eye with a poor outlook for vision.I need chemotherapy for my condition.My retinoblastoma can be managed with less invasive treatments.I have HIV but my CD4+ T-cell count is above 350 and I haven't had an AIDS-related infection in the last year.I have advanced retinoblastoma in both eyes and chemotherapy hasn't worked.My tests suggest my eye cancer may have spread to critical areas.I have a type of eye cancer in one eye that is not inherited.I was diagnosed with retinoblastoma when I was older than 4 months.
Research Study Groups:
This trial has the following groups:- Group 1: Intra-arterial injections of melphalan
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Melphalan a risk-free medication for patients?
"There is minimal prior clinical data available to support the safety of Melphalan, so it has been assigned a score of 1."
Answered by AI
Are new participants being welcomed into this research endeavor?
"Affirmative. Clinicaltrials.gov provides evidence that this study is currently enrolling patients, with the initial listing being uploaded on August 11th 2020 and the most recent update occurring November 16th 2022. The research team is seeking 5 volunteers at one site for their investigation."
Answered by AI
What conditions are usually treated with Melphalan?
"Melphalan is a commonly prescribed medication to treat multiple myeloma, as well as other hematopoietic stem cell diseases, forms of carcinomas, and foundations for stem cell transplantation."
Answered by AI
What is the overall participant count for this experiment?
"Affirmative. The clinical trial is still searching for volunteers, as indicated by the data on clinicialtrials.gov. Initially posted on August 11th 2020 and last modified November 16th 2022, this study requires 5 persons to join at a single location."
Answered by AI
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