Intra-arterial Chemotherapy for Children With Retinoblastoma

Hadassah Medical Center

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Retinoblastoma

Treatments: Drug: Injection of melphalan into the ophthalmic artery; Drug: Intra-arterial injection of melphalan

Study type: Interventional

Funder types: Other

Identifiers

NCT00906113

0058-09-HMO

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 6 months to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Intra-arterial melphalan

Experimental group

Description:

The patients will be treated by injection of chemotherapy (melphalan) into the ophthalmic artery of an eye affected by retinoblastoma

Treatment:

Drug: Intra-arterial injection of melphalan

Drug: Injection of melphalan into the ophthalmic artery