Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors (NCT02375204)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Children's Hospital of Alabama — Birmingham, Alabama
Age range: 14 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (125 Sites)
Showing the first 25 of 125 sites.
- Children's Hospital of Alabama — Birmingham, Alabama
- UC San Diego Moores Cancer Center — La Jolla, California
- Loma Linda University Medical Center — Loma Linda, California
- USC / Norris Comprehensive Cancer Center — Los Angeles, California
- Kaiser Permanente-Oakland — Oakland, California
- Stanford Cancer Institute Palo Alto — Palo Alto, California
- UCSF Medical Center-Mission Bay — San Francisco, California
- Alfred I duPont Hospital for Children — Wilmington, Delaware
- MedStar Georgetown University Hospital — Washington D.C., District of Columbia
- University of Florida Health Science Center - Gainesville — Gainesville, Florida
- Nemours Children's Clinic-Jacksonville — Jacksonville, Florida
- Nicklaus Children's Hospital — Miami, Florida
- Miami Cancer Institute — Miami, Florida
- Arnold Palmer Hospital for Children — Orlando, Florida
- Johns Hopkins All Children's Hospital — St. Petersburg, Florida
- Saint Joseph's Hospital/Children's Hospital-Tampa — Tampa, Florida
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia
- Northwestern University — Chicago, Illinois
- Rush University Medical Center — Chicago, Illinois
- University of Illinois — Chicago, Illinois
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois
- Ascension Via Christi Hospitals Wichita — Wichita, Kansas
- Cancer Center of Kansas - Wichita — Wichita, Kansas
- Ochsner Medical Center Jefferson — New Orleans, Louisiana
- Dana-Farber Cancer Institute — Boston, Massachusetts
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Germ Cell Tumor
- Proton Beam Radiation Therapy for Central Nervous System (CNS) Germ Cell Tumors — Boston, Massachusetts
- Evaluating Immune Therapy, Duravalumab (MEDI4736) With Tremelimumab for Relapsed/Refractory Germ Cell Tumors — Basking Ridge, New Jersey
- A Study of miRNA 371 in Patients With Germ Cell Tumors — Gilbert, Arizona
- A Phase II Trial of Cabozantinib With Patients With Refractory GCTs — Indianapolis, Indiana
- Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours — New York, New York
Explore by condition: All Germ Cell Tumor clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.