Intra-arterial Chemotherapy for Retinoblastoma

(IAC Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Margaret Reynolds, M.D.

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Children with retinoblastoma who may benefit from intra-arterial chemotherapy will receive up to 3 doses of melphalan and will be assessed for feasibility, toxicity, and response.

Eligibility Criteria

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.

Inclusion Criteria

My next treatment options include chemotherapy, radiotherapy, or eye removal.

Other patients may be considered on a case by case basis after discussion with pediatric ophthalmology, hematology/oncology, and interventional neuroradiology.

Patient or parent/legal guardian must sign a written informed consent

Exclusion Criteria

I do not have any uncontrolled illnesses or heart problems.

A history of allergic reactions attributed to compounds of similar composition to melphalan or other study agents

Currently receiving any other investigational agents

Participant Groups

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.

Group I: Intra-arterial injections of melphalan Experimental Treatment 1 Intervention

-Participants will receive intra-arterial injections of melphalan Q4W for 3 cycles.

Melphalan is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Alkeran for:

• Multiple myeloma
• Malignant lymphoma
• Acute lymphoblastic leukemia
• Acute myeloblastic leukemia
• Childhood neuroblastoma
• Ovarian cancer
• Mammary adenocarcinoma

🇺🇸 Approved in United States as Alkeran for:

• Multiple myeloma
• High-dose conditioning before hematopoietic stem cell transplant
• Uveal melanoma with unresectable hepatic metastases

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Washington University School of Medicine (Saint Louis Children's Hospital) Saint Louis, MO

Who Is Running the Clinical Trial?

Washington University School of Medicine Lead Sponsor

References