About this study
Germ cells are part of the body’s normal reproductive system. Sometimes, these cells may later develop into tumors. These are called germ cell tumors and may develop in the ovaries or testicles as well as in other parts of the body. Germ cell tumors may be benign (not cancerous) or malignant (cancerous). Malignant germ cell tumors may be treated with surgery and/or cancer drugs, also known as chemotherapy.
Some tumors come back after treatment or do not respond to treatment. These patients are usually treated with one of two types of chemotherapy: standard-dose or high-dose. Standard-dose chemotherapy, also known as conventional-dose chemotherapy, generally includes three drugs given together. High-dose chemotherapy usually includes two drugs given at much higher doses than traditional chemotherapy. Both standard-dose chemotherapy and high-dose chemotherapy have been shown to shrink cancer in patients whose cancer has come back after initial chemotherapy treatments. However, doctors do not know if one is better than the other.
This study will compare the two types of chemotherapy in boys with germ cell tumors that have come back after initial chemotherapy treatment or that did not respond to treatment. The study has two groups: Group 1 and Group 2. A computer will randomly assign boys to one group or the other. Boys in Group 1 will receive standard-dose chemotherapy. Boys in Group 2 will receive high-dose chemotherapy.
Eligibility overview
- 14 years old or older
- Diagnosis of germ cell tumor (GCT)
- Previously received 3 to 6 cycles of cisplatin-based chemotherapy
- No more than one prior line of chemotherapy
- No prior treatment with high-dose chemotherapy