Trial ID or NCT#

NCT02375204

Status

RECRUITING

Purpose

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.

Official 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

Eligibility Criteria

Ages Eligible for Study: Older than 14 Years
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No

Investigator(s)

Sandy Srinivas
Medical oncologist, Urologic specialist, Genitourinary specialist
Professor of Medicine (Oncology) at the Stanford University Medical Center
Harcharan Gill
Urologic oncologist, Urologist, Genitourinary specialist
Kathryn Simmons Stamey Professor
Laura Johnston
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Medical oncologist, Hematologist
Professor of Medicine (Blood and Marrow Transplantation) at the Stanford University Medical Center
Wen-Kai Weng, MD, PhD
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Lymphoma specialist, Medical oncologist, Multiple myeloma specialist
Associate Professor of Medicine (Blood and Marrow Transplantation) and, by courtesy, of Dermatology at the Stanford University Medical Center
Robert Lowsky
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation) at the Stanford University Medical Center
Lori Muffly
Hematologist, Blood and marrow transplant specialist, Blood and marrow transplant specialist
Assistant Professor of Medicine (Blood and Marrow Transplantation) at the Stanford University Medical Center
Heather Wakelee
Medical oncologist, Thoracic specialist
Professor of Medicine (Oncology) at the Stanford University Medical Center
Alice C. Fan
Medical oncologist, Genitourinary specialist
Assistant Professor of Medicine (Oncology) at the Stanford University Medical Center
Andrew Rezvani, M.D.
Blood and marrow transplant specialist, Blood and marrow transplant specialist
Assistant Professor of Medicine (Blood and Marrow Transplantation) at the Stanford University Medical Center

Contact us to find out if this trial is right for you.

CONTACT

Kelly Chan
(650) 625-8130