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Intra-arterial (Ophthalmic Artery) Chemotherapy for Retinoblastoma


N/A
N/A
N/A
Open (Enrolling)
Both
Retinoblastoma

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Trial Information

Intra-arterial (Ophthalmic Artery) Chemotherapy for Retinoblastoma


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.


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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor control

Outcome Time Frame:

after 5 cycles of chemotherapy

Safety Issue:

Yes

Principal Investigator

Carol L Shields, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oncology Service, Wills Eye Institute

Authority:

United States: Food and Drug Administration

Study ID:

08-885

NCT ID:

NCT00857519

Start Date:

January 2009

Completion Date:

April 2014

Related Keywords:

  • Retinoblastoma
  • retinoblastoma
  • Intraarterial
  • Chemotherapy
  • Melphalan
  • Carboplatin
  • Retinoblastoma

Name

Location

Oncology Service, Wills Eye InstitutePhiladelphia, Pennsylvania  19107