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NCT00179920 · ClinicalTrials.gov registry record · Phase 2

Chemotherapy Treatment for Children With Intraocular Germ-Line Retinoblastoma

A Phase 2 study of Retinoblastoma and Retinal Neoplasms, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.

Completed
Registry status
Phase 2
Development phase
30
Enrollment target
1
Study location

NCT00179920 is a Phase 2 study of Retinoblastoma and Retinal Neoplasms that has completed, run by Ann & Robert H Lurie Children's Hospital of Chicago. The registered enrollment target is 30 participants, below the 591-participant average among 15 other Retinoblastoma trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00179920, a Phase 2 study of Retinoblastoma and Retinal Neoplasms, has completed, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.

COMPLETED
Registry status
Phase 2
Development phase
30 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • DRUG Carboplatin
  • PROCEDURE Cryotherapy
  • DRUG VP-16
  • PROCEDURE Local Surgery
  • PROCEDURE Laser hyperthermia

Study Locations (1)

Illinois

  • Children's Memorial Hospital - Chicago

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 1996-04
Est. Completion 2006-09
Phase Phase 2

What the Registry Record Tells You About NCT00179920

The ClinicalTrials.gov registry entry for NCT00179920 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 591-participant average among 15 other Retinoblastoma trials with a reported enrollment target (95% lower). The listed sponsor is Ann & Robert H Lurie Children's Hospital of Chicago, which has 159 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Retinoblastoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.

NCT00179920 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.

Frequently Asked Questions

What is clinical trial NCT00179920 about?

NCT00179920 is a clinical study titled "Chemotherapy Treatment for Children With Intraocular Germ-Line Retinoblastoma". 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 temp...

What is the current status of trial NCT00179920?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 1996-04. Estimated completion is 2006-09.

What conditions does trial NCT00179920 study?

This clinical trial studies the following conditions: Retinoblastoma, Retinal Neoplasms.

What interventions are being tested in trial NCT00179920?

The interventions under investigation include: Carboplatin (DRUG), Cryotherapy (PROCEDURE), VP-16 (DRUG), Local Surgery (PROCEDURE), Laser hyperthermia (PROCEDURE).

Who is sponsoring clinical trial NCT00179920?

This trial is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago, which has 159 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00179920 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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