CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 60 enrolled
Drug / intervention
Carboplatin +10 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00554788
NCT00554788Phase 3Completed

A Trial of Intensive Multi-Modality Therapy for Extra-Ocular Retinoblastoma

Children's Oncology Group·interventional·Posted Nov 7, 2007·Updated Jan 13, 2025

In Brief

A Phase 3 clinical trial evaluating Autologous Bone Marrow Transplantation, Autologous Hematopoietic Stem Cell Transplantation, and 9 other interventions for Extraocular Retinoblastoma. Completed, enrolled 60 participants across 73 sites in 6 countries.

Detailed Summary

This phase III trial is studying the side effects and how well giving combination chemotherapy together with autologous stem cell transplant and/or radiation therapy works in treating young patients with extraocular retinoblastoma. Giving chemotherapy before an autologous stem cell transplant stops the growth of tumor cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and/or bone marrow and stored. More chemotherapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Radiation therapy uses high energy x-rays to kill tumor cells. Giving radiation therapy after combination chemotherapy and/or autologous stem cell transplant may kill any remaining tumor cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Brazil, Canada, Egypt, United States

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 7, 2007
Enrollment StartMay 6, 2008
Primary CompletionJun 30, 2018
Study CompletionDec 31, 2024
TodayJul 2, 2026
Enrollment to primary: 10.2 yearsPosted 18.7 years ago

Interventions

Autologous Bone Marrow Transplantationprocedure

Undergo peripheral blood stem cell or bone marrow transplant

Autologous Hematopoietic Stem Cell Transplantationprocedure

Undergo peripheral blood stem cell or bone marrow transplant

Carboplatindrug

Given IV

Cisplatindrug

Given IV

Cyclophosphamidedrug

Given IV

Etoposidedrug

Given IV

Filgrastimbiological

Given SC

In Vitro-Treated Peripheral Blood Stem Cell Transplantationprocedure

Undergo peripheral blood stem cell or bone marrow transplant

Radiation Therapyradiation

Undergo radiotherapy

Thiotepadrug

Given IV

Vincristine Sulfatedrug

Given IV