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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Wills Eye
Sponsor:
Collaborator:
Thomas Jefferson University
Information provided by (Responsible Party):
Carol L Shields, Wills Eye
ClinicalTrials.gov Identifier:
NCT00857519
First received: March 4, 2009
Last updated: June 12, 2013
Last verified: June 2013
  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

Resource links provided by NLM:


Further study details as provided by Wills Eye:

Primary Outcome Measures:
  • 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 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemotherapy 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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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: NCT00857519

Contacts
Contact: Carol L Shields, MD 215-928-3105 carol.shields@shieldsoncology.com

Locations
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         
Sponsors and Collaborators
Wills Eye
Thomas Jefferson University
Investigators
Principal Investigator: Carol L Shields, MD Oncology Service, Wills Eye Institute
  More Information

No publications provided

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, no grant
Study First Received: March 4, 2009
Last Updated: June 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Wills Eye:
retinoblastoma
Intraarterial
Chemotherapy
Melphalan
Carboplatin

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
Carboplatin
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 November 20, 2014