Intra-arterial Chemotherapy for Children With Retinoblastoma
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ClinicalTrials.gov Identifier: NCT00906113 |
Recruitment Status : Unknown
Verified October 2016 by Michael Weintraub, Hadassah Medical Organization.
Recruitment status was: Recruiting
First Posted : May 21, 2009
Last Update Posted : October 4, 2016
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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.
Condition or disease | Intervention/treatment | Phase |
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Retinoblastoma | Drug: Intra-arterial injection of melphalan Drug: Injection of melphalan into the ophthalmic artery | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase 1-2 Study of Injection of Melphalan Into the Ophthalmic Artery in Children With Retinoblastoma |
Study Start Date : | June 2011 |
Estimated Primary Completion Date : | December 2017 |
Estimated Study Completion Date : | December 2017 |

Arm | Intervention/treatment |
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Experimental: Intra-arterial melphalan
The patients will be treated by injection of chemotherapy (melphalan) into the ophthalmic artery of an eye affected by retinoblastoma
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Drug: Intra-arterial injection of melphalan
Injection of 5 milligrams of melphalan into the ophthalmic artery once every 3 weeks for a total of 6 courses Drug: Injection of melphalan into the ophthalmic artery Injection of 5 milligrams of melphalan into the ophthalmic artery in an eye affected by retinoblastoma |
- Salvage of eye and vision [ Time Frame: Three years from intervention ]

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Ages Eligible for Study: | 6 Months to 10 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Children with retinoblastoma in a single remaining eye with useful vision
Exclusion Criteria:
- None

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00906113
Contact: Michael Weintraub, MD | 972-2-6777408 | michaelw@hadassah.org.il | |
Contact: Jacob Pe'er, MD | 972-26778431 |
Israel | |
Hadassah University Hospital | Recruiting |
Jerusalem, Israel, 91120 | |
Contact: Michael Weintraub, MD michaelw@hadassah.org.il | |
Principal Investigator: Michael Weintraub, MD |
Responsible Party: | Michael Weintraub, DIrector, Pediatric Hematology Oncology, Hadassah Medical Organization |
ClinicalTrials.gov Identifier: | NCT00906113 |
Other Study ID Numbers: |
0058-09-HMO |
First Posted: | May 21, 2009 Key Record Dates |
Last Update Posted: | October 4, 2016 |
Last Verified: | October 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Retinoblastoma |
Retinoblastoma 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 Melphalan Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |