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A Study of the Effectiveness of a Local Injection of Chemotherapy for Retinoblastoma (IAC-RB)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00857519
First Posted: March 6, 2009
Last Update Posted: December 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Thomas Jefferson University
Information provided by (Responsible Party):
Carol L Shields, Wills Eye
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intra-arterial (Ophthalmic Artery) Chemotherapy for Retinoblastoma

Resource links provided by NLM:


Further study details as provided by Carol L Shields, Wills Eye:

Primary Outcome Measures:
  • Tumor control [ Time Frame: after 5 cycles of chemotherapy ]

Enrollment: 10
Study Start Date: January 2009
Study Completion Date: April 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemotherapy
Chemotherapy using Melphalan, Carboplatin.
Drug: Melphalan, Carboplatin
Intra-arterial chemotherapy.
Other Name: ALKERAN,PARAPLATIN

Detailed Description:
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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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)
  Contacts and Locations
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
  More Information

Publications:
Responsible Party: Carol L Shields, Carol L. Shields, MD Co-Director, Ocular Onology Service, Wills Eye
ClinicalTrials.gov Identifier: NCT00857519     History of Changes
Other Study ID Numbers: 08-885
First Submitted: March 4, 2009
First Posted: March 6, 2009
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:
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
Carboplatin
Melphalan
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs


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