This randomised phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumours that have returned after a period of improvement or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then 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. It is not yet known whether high-dose combination chemotherapy and stem cell transplant are more effective than standard-dose combination chemotherapy in treating patients with refractory or relapsed germ cell tumours.
The current gold standard practice for the treatment of germ cell tumours is the use of a chemotherapy combination called BEP which consists of three chemotherapy agents, Bleomycin, Etoposide and Cisplatin administered on a 3 weekly cycle. BEP is given with a drug called pegylated G-CSF (or pegfilgrastim) which stimulates white blood cell production.
The purpose of this study is to determine whether giving the same dose of BEP on a 2-weekly schedule will be more effective than a 3-weekly schedule and will be well tolerated. The 2-weekly schedule is called ‘accelerated BEP’.