A Study of the Effectiveness of a Local Injection of Chemotherapy for Retinoblastoma (IAC-RB)
Recruitment status was Recruiting
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Purpose
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 | Intervention |
|---|---|
|
Retinoblastoma |
Drug: Melphalan, Carboplatin |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Intra-arterial (Ophthalmic Artery) Chemotherapy for Retinoblastoma |
- Tumor control [ Time Frame: after 5 cycles of chemotherapy ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 10 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | April 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
-
Drug: Melphalan, Carboplatin
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| Contact: Carol L Shields, MD | 215-928-3105 | carol.shields@shieldsoncology.com |
| United States, Pennsylvania | |
| Oncology Service, Wills Eye Institute | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Carol L Shields, MD 215-928-3105 carol.shields@shieldsoncology.com | |
| Principal Investigator: Carol L Shields, MD | |
| Principal Investigator: | Carol L Shields, MD | Oncology Service, Wills Eye Institute |
More Information
No publications provided
| Responsible Party: | Carol L Shields, MD, Oncology Service, Wills Eye Institute |
| ClinicalTrials.gov Identifier: | NCT00857519 History of Changes |
| Other Study ID Numbers: | 08-885, no grant |
| Study First Received: | March 4, 2009 |
| Last Updated: | January 14, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Wills Eye:
|
retinoblastoma Intraarterial Chemotherapy Melphalan Carboplatin |
Additional relevant MeSH terms:
|
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 Retinal Diseases |
Melphalan Carboplatin Myeloablative Agonists Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013