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Intra-arterial Chemotherapy for Children With Retinoblastoma

Phase 1-2 Study of Injection of Melphalan Into the Ophthalmic Artery in Children With Retinoblastoma

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00906113
Enrollment
10
Registered
2009-05-21
Start date
2011-06-30
Completion date
2017-12-31
Last updated
2016-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinoblastoma

Keywords

Retinoblastoma

Brief summary

Retinoblastoma is a cancer of the eye that occurs exclusively in children. The treatment for retinoblastoma may include surgery, chemotherapy, radiation and local treatments to the eye such as freezing (cryotherapy) and local radiation (brachytherapy). In some cases, a child with retinoblastoma will have active cancer in a single remaining eye with useful vision. In such cases, it is sometimes necessary to remove this eye. In such cases, the injection of chemotherapy directly into the artery that supplies the eye and the tumor may lead to regression of the tumor without the need to remove the eye. This form of treatment was pioneered by a group in New York (Abramson et al). In this study the investigators will assess the efficacy and safety of the technique in a group of children with retinoblastoma.

Interventions

DRUGIntra-arterial injection of melphalan

Injection of 5 milligrams of melphalan into the ophthalmic artery once every 3 weeks for a total of 6 courses

DRUGInjection of melphalan into the ophthalmic artery

Injection of 5 milligrams of melphalan into the ophthalmic artery in an eye affected by retinoblastoma

Sponsors

Hadassah Medical Organization
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 10 Years
Healthy volunteers
No

Inclusion criteria

* Children with retinoblastoma in a single remaining eye with useful vision

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frame
Salvage of eye and visionThree years from intervention

Countries

Israel

Contacts

Primary ContactMichael Weintraub, MD
michaelw@hadassah.org.il972-2-6777408
Backup ContactJacob Pe'er, MD
972-26778431

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026