Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors

Running, not enrolling · Phase 3

Conditions studied: Germ Cell Tumor, Teratoma, Choriocarcinoma, Germinoma, Mixed Germ Cell Tumor, Yolk Sac Tumor, Childhood Teratoma, Malignant Germ Cell Neoplasm, Extragonadal Seminoma, Non-seminomatous Germ Cell Tumor, Seminoma

In brief

This randomized 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 tumors 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 tumors.

Key facts

Study ID

NCT02375204

Run by

Alliance for Clinical Trials in Oncology

People needed

420

Starts

2015-08-06

Expected to finish

2031-06-01

Last updated by the study team

2026-06-16

Who can join

Age: 14 and older. Sex: male. Healthy volunteers: not accepted.

Where it is running

• UC San Diego Moores Cancer Center — La Jolla, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Kaiser Permanente-Oakland — Oakland, California, United States
• Stanford Cancer Institute Palo Alto — Palo Alto, California, United States
• UCSF Medical Center-Mission Bay — San Francisco, California, United States
• Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• University of Florida Health Science Center - Gainesville — Gainesville, Florida, United States
• Nemours Children's Clinic-Jacksonville — Jacksonville, Florida, United States
• Nicklaus Children's Hospital — Miami, Florida, United States
• Miami Cancer Institute — Miami, Florida, United States
• Arnold Palmer Hospital for Children — Orlando, Florida, United States
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
• Saint Joseph's Hospital/Children's Hospital-Tampa — Tampa, Florida, United States
• Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Illinois — Chicago, Illinois, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Ascension Via Christi Hospitals Wichita — Wichita, Kansas, United States
• Cancer Center of Kansas - Wichita — Wichita, Kansas, United States
• Ochsner Medical Center Jefferson — New Orleans, Louisiana, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Children's Hospital of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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