MedTrace Logo

Combination Chemotherapy, Autologous Stem Cell Transplant, and/or Radiation Therapy in Treating Young Patients With Extraocular Retinoblastoma

NCT00554788 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-01-13

Study results available
· View outcomes & findings →

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.

Conditions

  • Extraocular Retinoblastoma

Interventions

PROCEDURE

Autologous Bone Marrow Transplantation

Undergo peripheral blood stem cell or bone marrow transplant

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Undergo peripheral blood stem cell or bone marrow transplant

DRUG

Carboplatin

Given IV

DRUG

Cisplatin

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Etoposide

Given IV

BIOLOGICAL

Filgrastim

Given SC

PROCEDURE

In Vitro-Treated Peripheral Blood Stem Cell Transplantation

Undergo peripheral blood stem cell or bone marrow transplant

RADIATION

Radiation Therapy

Undergo radiotherapy

DRUG

Thiotepa

Given IV

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Ira J Dunkel · Children's Oncology Group

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-06
Primary Completion
2018-06-30
Completion
2024-12-31

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Canada
  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00554788 on ClinicalTrials.gov