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AGCT1531: Carboplatin vs. Cisplatin for germ cell tumors

About this study

Germ cell tumors are formed by a type of reproductive cell called a germ cell. About 85% of children with germ cell tumors survive after treatment. Despite this good survival rate, many patients develop side effects from their treatment later in their lives (known as late effects). These late effects include a higher risk of getting another cancer or heart disease.

Doctors often use a chemotherapy drug called cisplatin to treat germ cell tumors. Cisplatin can kill cancer cells, but it can also harm normal cells. This can increase the risk of late effects.

In this study, patients will be put into either a low-risk group or a standard-risk group, depending on their risk of getting cancer again after treatment. These groups are:

  • Low-risk group: patients in this group will be watched closely after surgery for any cancer that comes back. They will not get chemotherapy, which may reduce their risk of late effects. If their cancer does return and they are eligible, they may join the standard-risk group and get more treatment.
  • Standard-risk group: these patients are usually treated with 3 chemotherapy drugs to kill their cancer: cisplatin, etoposide, and bleomycin. Standard-risk patients will be    put into 1 of 2 groups at random:
    • Standard-risk group 1 will get the standard treatment with cisplatin, etoposide, and bleomycin.
    • Standard-risk group 2 will get a less-toxic drug, carboplatin, instead of cisplatin. Carboplatin was successfully used in other studies to treat cancer. This group will get carboplatin, etoposide, and bleomycin.

Purpose of this clinical trial

The purpose of this study is to see if:

  • Watching patients with low-risk germ cell tumors, after tumor removal, treats their tumor as well as if they got the usual treatment of chemotherapy and/or more surgery if needed.
  • Collect data and blood samples to develop new tests to diagnose cancer.
  • Compare the effects of carboplatin and cisplatin on people with standard-risk germ cell tumors to find out which treatment is better. In this study, the patient will get either carboplatin or cisplatin. They will not get both.

Eligibility overview

Low-risk group

  • No age limit
  • Stage 1 germ cell tumor

Standard-risk group

  • Standard Risk Group 1: less than 11 years old
  • Standard risk Group 2: ages 11–25
  • Stages 2-4
  • Adequate organ function only for patients receiving chemotherapy

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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.

Overview

Full title:

AGCT1531: A Phase 3 Study of Active Surveillance for Low-risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard-risk Pediatric and Adult Patients with Germ Cell Tumors

Study goal:

Watch patients with low-risk germ cell tumors, after tumor removal, treats their tumor as well as if they got the usual treatment of chemotherapy and/or more surgery if needed.

Diagnosis:

Germ cell tumor, Yolk sac tumor

Age:

Standard Risk Group 1: less than 11 years old; Standard risk Group 2: ages 11–25

Clinical trials categories:

Childhood Cancer Yolk Sac Tumor Solid Tumors Germ Cell Tumors (Solid Tumor)

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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