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AGCT1532: BEP Chemotherapy for Germ Cell Tumors

About this study

Germ cell tumors are formed by a type of reproductive cell called a germ cell. Germ cell tumors can be put into 3 different “risk” groups, depending on how much the tumor has grown. The 3 risk groups are: good, intermediate, and poor. Intermediate and poor-risk tumors are called “advanced” germ cell tumors. These tumors are harder to cure and may need stronger therapy to kill the cancer.

The standard treatment for treating germ cell tumors is to use 3 chemotherapy drugs called bleomycin, etoposide, and cisplatin, along with another drug called pegfilgrastim (filgrastim). Pegfilgrastin makes disease-fighting white blood cells grow better.

In this study, patients with advanced germ cell tumors will be treated with either standard chemotherapy or accelerated chemotherapy. Each treatment plan uses the same drugs, but the drugs are given in 2 different ways:

  • Standard chemotherapy: bleomycin, etoposide, cisplatin, and pegfilgrastim (filgrastim) given every 3 weeks (21 days) for a total of 4 times (cycles)
  • Accelerated chemotherapy: bleomycin, etoposide, cisplatin, and pegfilgrastim (filgrastim) given every 2 weeks (14 days) for a total of 4 times (cycles). This will be followed by 4 weekly doses of the drug bleomycin alone. With accelerated chemotherapy, the drugs are given faster, with the hope that this will fight the patient’s cancer better.

Purpose of this clinical trial

The purpose of this study is to find out if accelerated chemotherapy will treat germ cell tumors as well as standard. We will also see if both treatments have similar side effects and are well tolerated.

Eligibility overview

  • Ages 11–45 years
  • Diagnosis of germ cell tumor
  • Germ cell tumor that has spread
  • Intermediate or poor prognosis
  • Adequate organ function

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:

AGCT1532: A Randomized Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-Risk Metastatic Germ Cell Tumors

Study goal:

The purpose of this study is to find out if accelerated chemotherapy will treat germ cell tumors as well as standard. We will also see if both treatments have similar side effects and are well tolerated.

Diagnosis:

Germ cell tumor

Age:

Ages 11–45 years

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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