Intra-arterial Chemotherapy for Children With Retinoblastoma

NCT00906113 | Unknown Phase 1

• 1 other identifier: 0058-09-HMO
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinoblastoma

Keywords

Retinoblastoma

Outcome Measures

Primary Outcomes (1)

• Salvage of eye and vision

  Three years from intervention

Study Arms (1)

Intra-arterial melphalan

EXPERIMENTAL

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

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

Interventions

Intra-arterial injection of melphalan DRUG

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

Intra-arterial melphalan

Injection of melphalan into the ophthalmic artery DRUG

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

Intra-arterial melphalan

Eligibility Criteria

• Age: 6 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah University Hospital

Jerusalem, 91120, Israel

RECRUITING

MeSH Terms

Conditions

Retinoblastoma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Retinal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases

Central Study Contacts

Michael Weintraub, MD

CONTACT

972-2-6777408; michaelw@hadassah.org.il

Jacob Pe'er, MD

CONTACT

972-26778431

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DIrector, Pediatric Hematology Oncology

Study Record Dates

• First Submitted: May 19, 2009
• First Posted: May 21, 2009
• Study Start: June 1, 2011
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 4, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

IL (1)