drugset / Trial / NCT00554788

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

NCT00554788 ↗

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

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

Outcome

Met primary endpoint

paper Although the study met its aim for stage IVb, more effective therapy is still required for patients with CNS involvement PMID 35820112 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule — Intravenous
Subject Cisplatin Other / unclassified — Intravenous
Subject Cyclophosphamide Other / unclassified — Intravenous
Subject Etoposide Small molecule — Intravenous
Subject Thiotepa Other / unclassified — Intravenous
Subject Vincristine Small molecule — Intravenous
Background filgrastim Protein / enzyme biologic — Subcutaneous