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| Sponsor: | Children's Memorial Hospital |
|---|---|
| Information provided by: | Children's Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT00179920 |
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Retinoblastoma Retinal Neoplasms |
Drug: Carboplatin Drug: VP-16 Procedure: Local Surgery Procedure: Cryotherapy Procedure: Laser hyperthermia |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Control: Uncontrolled Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Chemotherapy Plus Local Surgical Treatment in Children With Intraocular Germ-Line Retinoblastoma |
| Estimated Enrollment: | 30 |
| Study Start Date: | April 1996 |
| Estimated Study Completion Date: | September 2006 |
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Eligibility Criteria:
Contacts and Locations| United States, Illinois | |
| Children's Memorial Hospital | |
| Chicago, Illinois, United States, 60614 | |
| Principal Investigator: | Stewart Goldman, MD | Children's Memorial Hospital |
More Information
| Study ID Numbers: | CNS 0294 |
| Study First Received: | September 12, 2005 |
| Last Updated: | September 13, 2006 |
| ClinicalTrials.gov Identifier: | NCT00179920 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Retinal Neoplasms Neoplasms by Histologic Type Eye Neoplasms Antineoplastic Agents Eye Diseases Neoplasms, Nerve Tissue Carboplatin Retinoblastoma Pharmacologic Actions |
Neuroectodermal Tumors Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Neoplasms, Neuroepithelial Retinal Diseases Neoplasms, Glandular and Epithelial |