drugset / Trial / NCT00588523

Intensive Chemotherapy and Autotransplantation for Patients With Newly Diagnosed Anaplastic Oligodendroglioma

NCT00588523

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to see how effective treatment of high doses of chemotherapy is for your tumor. We will also be looking at the side effects and risks of this treatment. You will receive very high doses of chemotherapy. High doses of chemotherapy can destroy tumor cells, but it can also destroy normal bone marrow cells. These cells produce white blood cells (which fight infection), red blood cells (which carry oxygen) and platelets (which allow your blood to clot). With too few of these cells there is a serious risk of infection and bleeding. Therefore, before treatment begins, we will collect some of your own blood cells, called peripheral blood progenitor cells (PBPCs). These cells help create new blood cells. The PBPCs are frozen and saved while you are being treated. Then at the end of treatment, your PBPCs are thawed and given back to you. These healthy PBPCs will replace the blood cells that the high dose chemotherapy destroys and allow your bone marrow to recover and produce blood cells. In a prior study we treated 69 patients in a similar way. More than half were able to avoid or delay brain radiation. This new study will use a different high dose chemotherapy regimen.

Timeline

Start
2002-09
Primary completion
2023-02-02
Completion
2023-02-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Busulfan Small molecule 3.2 mg/kg Intravenous
Subject Temozolomide Small molecule 200 mg/m2 Oral
Subject Thiotepa Other / unclassified 250 mg/m2 Intravenous