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A031102: Standard-Dose Combination Chemotherapy Compared to High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients with Relapsed or Refractory Germ Cell Tumors

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

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.


Full title:

A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) With High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors

Study goal:

The main goal of this study is to find out the good and bad effects of standard-dose chemotherapy compared to high-dose chemotherapy.


Germ cell tumor


14 years or older

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.


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