A Study of the Effectiveness of a Local Injection of Chemotherapy for Retinoblastoma (IAC-RB)
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| ClinicalTrials.gov Identifier: NCT00857519 |
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Recruitment Status :
Completed
First Posted : March 6, 2009
Last Update Posted : December 12, 2016
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Sponsor:
Wills Eye
Collaborator:
Thomas Jefferson University
Information provided by (Responsible Party):
Carol L Shields, Wills Eye
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Brief Summary:
Over the past 15 years, intravenous chemotherapy has become the most popular conservative (eye-saving) method for retinoblastoma treatment because it is often effective and usually safe. In recent years, there has been much interest in providing highly focused (focal) chemotherapy to a diseased organ including the liver, brain, and eye. With focused chemotherapy, the chemotherapy drugs are injected directly into the ophthalmic artery (the artery that supplies blood to the eye). A benefit of focal chemotherapy delivery is that it decreases the chance of toxicity to other organs such as bone marrow suppression (causing low blood counts) and the development of other cancers in the future.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Retinoblastoma | Drug: Melphalan, Carboplatin | Not Applicable |
The management of retinoblastoma includes systemic chemotherapy (carboplatin, etoposide, and vincristine), thermotherapy, cryotherapy (freezing treatment), laser photocoagulation, plaque radiotherapy, external beam radiotherapy, and enucleation. The treatment is tailored to each individual case. Over the past 15 years, intravenous chemotherapy has risen as the most popular conservative (eye-saving) method for retinoblastoma management because it is effective and safe. In recent years, there has been keen interest in providing chemotherapy more focally to a diseased organ including the liver, brain, and eye. The benefit of focal chemotherapy delivery is to avoid toxicity to other organs and this toxicity includes the risk of future cancers.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 10 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Intra-arterial (Ophthalmic Artery) Chemotherapy for Retinoblastoma |
| Study Start Date : | January 2009 |
| Actual Primary Completion Date : | March 2014 |
| Actual Study Completion Date : | April 2014 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Retinoblastoma
| Arm | Intervention/treatment |
|---|---|
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Experimental: Chemotherapy
Chemotherapy using Melphalan, Carboplatin.
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Drug: Melphalan, Carboplatin
Intra-arterial chemotherapy.
Other Name: ALKERAN,PARAPLATIN |
Primary Outcome Measures :
- Tumor control [ Time Frame: after 5 cycles of chemotherapy ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Advanced retinoblastoma in one or both eyes
- Recurrent retinoblastoma after failure of previous treatment
- No age limit (usually kids presenting with retinoblastoma present in the 1st two decades of life)
- Judged by principal investigator to be medically and physically able to undergo the procedure
Exclusion Criteria:
- Recurrent retinoblastoma which is treatable with other conservative measures
- Invasive retinoblastoma (retinoblastoma that has grown locally outside of the eye, for example, into the bone around the eye)
Information from the National Library of Medicine
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): NCT00857519
Locations
| United States, Pennsylvania | |
| Oncology Service, Wills Eye Institute | |
| Philadelphia, Pennsylvania, United States, 19107 | |
Sponsors and Collaborators
Wills Eye
Thomas Jefferson University
Investigators
| Principal Investigator: | Carol L Shields, MD | Oncology Service, Wills Eye Institute |
Publications:
| Responsible Party: | Carol L Shields, Carol L. Shields, MD Co-Director, Ocular Onology Service, Wills Eye |
| ClinicalTrials.gov Identifier: | NCT00857519 |
| Other Study ID Numbers: |
08-885 |
| First Posted: | March 6, 2009 Key Record Dates |
| Last Update Posted: | December 12, 2016 |
| Last Verified: | December 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Carol L Shields, Wills Eye:
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retinoblastoma Intraarterial Chemotherapy Melphalan Carboplatin |
Additional relevant MeSH terms:
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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 Carboplatin Melphalan Antineoplastic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Myeloablative Agonists Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |