Intra-arterial Chemotherapy for Children With Retinoblastoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Hadassah Medical Organization.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Hadassah Medical Organization
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00906113
First received: May 19, 2009
Last updated: June 22, 2011
Last verified: May 2009
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Retinoblastoma |
Drug: Intra-arterial injection of melphalan Drug: Injection of melphalan into the ophthalmic artery |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 1-2 Study of Injection of Melphalan Into the Ophthalmic Artery in Children With Retinoblastoma |
Resource links provided by NLM:
Genetics Home Reference related topics:
retinoblastoma
Genetic and Rare Diseases Information Center resources:
Children's Interstitial Lung Disease
Neuroepithelioma
Retinoblastoma
U.S. FDA Resources
Further study details as provided by Hadassah Medical Organization:
Primary Outcome Measures:
- Salvage of eye and vision [ Time Frame: Three years from intervention ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | June 2011 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intra-arterial melphalan
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
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
|
Eligibility| Ages Eligible for Study: | 6 Months to 10 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Children with retinoblastoma in a single remaining eye with useful vision
Exclusion Criteria:
- None
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00906113
Please refer to this study by its ClinicalTrials.gov identifier: NCT00906113
Contacts
| Contact: Michael Weintraub, MD | 972-2-6777408 | michaelw@hadassah.org.il | |
| Contact: Jacob Pe'er, MD | 972-26778431 |
Locations
| Israel | |
| Hadassah University Hospital | Recruiting |
| Jerusalem, Israel, 91120 | |
| Contact: Michael Weintraub, MD michaelw@hadassah.org.il | |
| Principal Investigator: Michael Weintraub, MD | |
Sponsors and Collaborators
Hadassah Medical Organization
More Information
No publications provided
| Responsible Party: | Michael Weintraub M.D., Hadassah University Hospital, Jerusalem, Israel |
| ClinicalTrials.gov Identifier: | NCT00906113 History of Changes |
| Other Study ID Numbers: | 0058-09-HMO |
| Study First Received: | May 19, 2009 |
| Last Updated: | June 22, 2011 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Hadassah Medical Organization:
|
Retinoblastoma |
Additional relevant MeSH terms:
|
Retinoblastoma Eye Diseases Eye Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Retinal Diseases |
Retinal Neoplasms Melphalan Alkylating Agents Antineoplastic Agents Antineoplastic Agents, Alkylating Immunologic Factors Immunosuppressive Agents Molecular Mechanisms of Pharmacological Action Myeloablative Agonists Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015