Brief Title
Chemotherapy Treatment for Children With Intraocular Germ-Line Retinoblastoma
Official Title
Chemotherapy Plus Local Surgical Treatment in Children With Intraocular Germ-Line Retinoblastoma
Brief Summary
Retinoblastoma is an unusual cancer of early childhood involving tumor is both eyes or, in
certain circumstances, one eye only. This condition is the result of an abnormal gene which
makes both retinas (the back of the eye) vulnerable to develop multiple tumors. Growths in
the eye impair vision temporarily or permanently. These tumors are malignant, which means
that they can grow within the eye, spread outside of the eye, and be fatal if untreated.
Standard therapy for bilateral retinoblastoma includes removal of one eye if vision cannot be
save and radiation treatment of either eye in which vision might be saved. Radiation controls
tumor growth in the majority of cases. Another standard method is cryotherapy (freezing a
tumor to kill it). Chemotherapy (medicines used to kill tumor cells) has been used in the
past for tumor in or outside the eye, but is not standard. Hyperthermia, increasing the
temperature of a tumor to kill it, is widely performed, and can be done to a retinoblastoma
tumor by a laser; this method is not standard.
The problem with removal of an eye is that any hope of vision is lost. The problems with
radiation include incomplete control of tumor, injury to the eye or surrounding tissue with
decreased growth, and that (due to the abnormal retinoblastoma gene) children are very
susceptible to develop other tumors, especially in the tissue which was given radiation.
The doctors at Children's Memorial Hospital are using a newer form of treatment, including
laser hyperthermia, chemotherapy and cryotherapy to decrease retinoblastoma tumors. Some may
be controlled indefinitely, reducing the number of eyes that need radiation or removal.
OBJECTIVES
1. To find out how well chemotherapy plus cryotherapy and laser hyperthermia work on
retinoblastoma tumors.
2. To find out whether vision can be saved and tumors controlled without radiation or
removal of the eye.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
To determine if a multimodal approach can provide durable control of retinoblastoma and specifically:
Secondary Outcome
To estimate the response rate and duration for primary retinoblastoma tumors to combination therapy with carboplatin and VP-16
Condition
Retinoblastoma
Intervention
Carboplatin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
30
Start Date
April 1996
Completion Date
September 2006
Eligibility Criteria
Eligibility Criteria:
- Initial clinical diagnosis of Retinoblastoma, with Bilateral tumors, OR Unilateral
tumor with hope for salvage of vision AND Multiple primary tumors, or positive family
history for retinoblastoma, or age < 12 months
- No prior antitumor therapy (except enucleation of one eye)
- At least one tumor exceeds 6 mm in diameter
- No evidence of dissemination outside the globe
- Signed IRB-approved informed consent
- Patient/family available for follow-up
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Stewart Goldman, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00179920
Organization ID
CNS 0294
Responsible Party
Principal Investigator
Study Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Study Sponsor
Stewart Goldman, MD, Principal Investigator, Ann & Robert H Lurie Children's Hospital of Chicago
Verification Date
August 2020