High-Dose chemo with stem cell transplant tested against standard therapy for tough germ cell cancers

NCT ID NCT02375204

Disease control Sponsor: Alliance for Clinical Trials in Oncology Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial compares two chemotherapy approaches for people with germ cell tumors that have returned or not responded to initial treatment. One group receives standard-dose chemotherapy with paclitaxel, ifosfamide, and cisplatin (TIP). The other receives high-dose chemotherapy with carboplatin and etoposide followed by a stem cell transplant (TI-CE). The study aims to see which approach improves overall survival more.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: paclitaxel, ifosfamide, cisplatin, carboplatin, etoposide, stem cell reinfusion
What this could lead to: If high-dose chemo with stem cell transplant proves more effective, it could become the new standard of care for patients whose germ cell tumors return or resist initial treatment.
What could go wrong: High-dose chemotherapy carries greater risks, including serious side effects and treatment-related death. The trial is still testing whether the benefits outweigh these risks.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

420 people

The number who actually took part.

Started

Aug 2015

Expected to finish

Jun 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

14 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

1. Documentation of Disease * Histologic Documentation: Confirmation of GCT histology (both seminoma and nonseminoma) on pathologic review at the center of enrollment. * Tumor may have originated in any primary site. NOTE: In rare circumstances, patients will be allowed to enroll even if a pathologic diagnosis may not have been established. * This would require a clinical situation consistent with the diagnosis of GCT (testicular, peritoneal, retroperitoneal or mediastinal mass, elevated tumor marker levels {HCG ≥ 500; AFP ≥ 500} and typical pattern of metastases) 2. Evidence of Disease * Must have evidence of progressive or recurrent GCT (measurable or non-measurable) following one line of cisplatin-based chemotherapy, defined as meeting at least one of the following criteria: * Tumor biopsy of new or growing or unresectable lesions demonstrating viable non-teratomatous GCT (enrollment on this study for adjuvant treatment after macroscopically complete resection of viable GCT is not allowed). In the event of an incomplete gross resection where viable GCT is found, patients will be considered eligible for the study. * Consecutive elevated serum tumor markers (HCG or AFP) that are increasing. Increase of an elevated LDH alone does not constitute progressive disease. * Development of new or enlarging lesions in the setting of persistently elevated HCG or AFP, even if the HCG and AFP are not continuing to increase. 3. Prior Treatment * Must have received 3-6 cycles of cisplatin-based chemotherapy as part of first-line (initial) chemotherapy. * Prior POMBACE, CBOP-BEP, or GAMEC are allowed. * Note: For patients requiring immediate treatment, 1 cycle of conventional-dose salvage chemotherapy is allowed. Therefore, these patients may have received 7 prior cycles of chemotherapy. 6 cycles as part of first-line chemotherapy and 1 cycle of salvage conventional chemotherapy. * No more than one prior line of chemotherapy for GCT (other than the 1 cycle of salvage chemotherapy as defined in the protocol) * Definition of one line of chemotherapy: One line of therapy can in some cases consist of 2 different cisplatin-based treatment combinations, provided there is no disease progression between these two regimens. * Prior treatment with carboplatin as adjuvant therapy is allowed, provided patients meet other eligibility criteria (e.g., the patient has also received 3-4 cycles of cisplatin-based chemotherapy). * Prior treatment with 1-2 cycles of BEP or EP as adjuvant chemotherapy for early stage GCT is allowed, provided the patient also received 3-4 cycles of BEP or EP again at relapse. Patients treated with 3-4 cycles of VIP at relapse following 1-2 cycles of BEP/EP are not eligible as this would be considered more than 1 line of prior therapy. * No prior treatment with high-dose chemotherapy (defined as treatment utilizing stem cell rescue) * No prior treatment with TIP with the exception when given as a bridge to treatment on protocol for patients with rapidly progressive disease who cannot wait to complete the eligibility screening process. Only one cycle is allowed. * No concurrent treatment with other cytotoxic drugs or targeted therapies. * No radiation therapy (other than to the brain) within 14 days of day 1 of protocol chemotherapy except radiation to brain metastases, which must be completed 7 days prior to start of chemotherapy. * No previous chemotherapy within 17 days prior to enrollment. A minimum of three weeks after the last day of the start of the previous chemotherapy regimen before the first day of chemotherapy on study protocol. * Must have adequate recovery from prior surgery (eg, healed scar, resumption of diet) 4. Age ≥ 14 years (≥ 18 years in Germany) 5. ECOG Performance Status 0 to 2 6. Male gender 7. Required Initial Laboratory Values: * Absolute Neutrophil Count (ANC) ≥ 1,500/mm\^3 * Platelet Count ≥ 100,000/mm\^3 * Calculated creatinine clearance ≥ 50 mL/min * Bilirubin ≤ 2.0 x upper limits of normal (ULN) * AST/ALT ≤ 2.5 x upper limits of normal (ULN) 8. No concurrent malignancy other than non-melanoma skin cancer, superficial noninvasive (pTa or pTis) TCC of the bladder, contralateral GCT, or intratubular germ cell neoplasia. Patients with a prior malignancy, but at least 2 years since any evidence of disease are allowed. 9. Negative Serology (antibody test) for the following infectious diseases: * Human Immunodeficiency Virus (HIV) type 1 and 2 * Human T-cell Leukemia Virus (HTLV) type 1 and 2 (mandatory in US but optional in Canada and Europe) * Hepatitis B surface antigen * Hepatitis C antibody 10. No late relapse with completely surgically resectable disease. Patients with late relapses (defined as relapse ≥ 2 years from the date of completion of the last chemotherapy regimen) whose disease is completely surgically resectable are not eligible. Patients with late relapses who have unresectable disease are eligible. 11. No large (≥ 2 cm) hemorrhagic or symptomatic brain metastases until local treatment has been administered (radiation therapy or surgery). Treatment may begin ≥ 7 days after completion of local treatment. Patients with small (\< 2 cm) and asymptomatic brain metastases are allowed and may be treated with radiation therapy and/or surgery concurrently with Arm A or cycles 1 and 2 of Arm B if deemed medically indicated. Radiation therapy should not be given concurrently with high-dose carboplatin or etoposide. 12. No secondary somatic malignancy arising from teratoma (e.g., teratoma with malignant transformation) when it is actively part of the disease recurrence or progression.

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Conditions

The condition(s) this trial relates to.

childhood teratoma of the ovary choriocarcinoma Endodermal Sinus Tumor extragonadal seminoma germ cell tumor germinoma malignant germ cell tumor mixed germ cell tumor Neoplasms, Germ Cell and Embryonal nongerminomatous germ cell tumor Nonseminomatous germ cell tumor seminoma teratoma yolk sac tumor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Childhood teratoma Choriocarcinoma Extragonadal seminoma Germ cell tumor Germinoma Malignant germ cell neoplasm Mixed germ cell tumor Non-seminomatous germ cell tumor Seminoma Teratoma Yolk sac tumor

Contacts and locations

Locations

Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803, United States
Arnold Palmer Hospital for Children

Orlando, Florida, 32806, United States
Ascension Via Christi Hospitals Wichita

Wichita, Kansas, 67214, United States
BI-LO Charities Children's Cancer Center

Greenville, South Carolina, 29605, United States
Beatson Oncology Center

Glasgow, Scotland, G12 0YN, United Kingdom
Box Hill Hospital

Box Hill, Victoria, 3128, Australia
CHRU Strasbourg - Hospital Civil

Strasbourg, 67091, France
Cancer Center of Kansas - Wichita

Wichita, Kansas, 67214, United States
Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203, United States
Center Claudius Regaud

Toulouse, 31052, France
Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France
Centre Leon Berard

Lyon, 69373, France
Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States
Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404, United States
Christie Hospital

Manchester, England, M20 4BX, United Kingdom
Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States
Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States
Duran i Reynals Hospital-Catalan Institute of Oncology

Barcelona, 08908, Spain
El Paso Children's Hospital

El Paso, Texas, 79905, United States
Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States
GK-Mittelrhein Saint Martin's

Koblenz, 56068, Germany
Gustave Roussy

Villejuif, 94805, France
Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States
Hopital Tenon/Assistance Publique - Hopitaux de Paris

Paris, 75970, France
Hopitaux Universitaires de Geneve

Geneva, 1211, Switzerland
Hospital De La Santa Creu I Sant Pau

Barcelona, 08025, Spain
Hospital General Universitario Morales Meseguer

Murcia, 30008, Spain
Hospital Universitario 12 de Octubre

Madrid, 28041, Spain
Inselspital

Bern, 3010, Switzerland
Institut Jules Bordet

Anderlecht, 1070, Belgium
Institut Paoli Calmettes

Marseille, 13273, France
Istituto Nazionale Tumori

Milan, 20133, Italy
Istituto Scientifico Romagnolo

Meldola, 47014, Italy
Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States
Kaiser Permanente-Oakland

Oakland, California, 94611, United States
Klinikum Nurnberg Nord

Nuremberg, 90419, Germany
Loma Linda University Medical Center

Loma Linda, California, 92354, United States
M D Anderson Cancer Center

Houston, Texas, 77030, United States
Marshfield Clinic-Minocqua Center

Minocqua, Wisconsin, 54548, United States
Marshfield Medical Center - Weston

Weston, Wisconsin, 54476, United States
Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701, United States
Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States
Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868, United States
Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482, United States
Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States
MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States
Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Medical University of South Carolina

Charleston, South Carolina, 29425, United States
Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States
Memorial Sloan Kettering Commack

Commack, New York, 11725, United States
Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States
Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States
Miami Cancer Institute

Miami, Florida, 33176, United States
Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States
Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, 32207, United States
Nicklaus Children's Hospital

Miami, Florida, 33155, United States
Northwestern University

Chicago, Illinois, 60611, United States
Nottingham City Hospital

Nottingham, NG5 1PB, United Kingdom
Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121, United States
Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States
Ospedale di Circolo di Busto Arsizio

Busto Arsizio, 21052, Italy
Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia
Philipps University Marburg

Marburg, 35033, Germany
Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia
Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Easley

Easley, South Carolina, 29640, United States
Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States
Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Greer

Greer, South Carolina, 29650, United States
Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672, United States
Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, 29316, United States
Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States
Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands
Rhode Island Hospital

Providence, Rhode Island, 02903, United States
Rigshospitalet University Hospital

Copenhagen, 2100, Denmark
Roswell Park Cancer Institute

Buffalo, New York, 14263, United States
Rotkreuzklinikum Munchen

Munich, 80634, Germany
Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia
Rush University Medical Center

Chicago, Illinois, 60612, United States
Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom
Saint Francis Cancer Center

Greenville, South Carolina, 29607, United States
Saint Francis Hospital

Greenville, South Carolina, 29601, United States
Saint James Hospital

Dublin, 8, Ireland
Saint James's University Hospital

West Yorkshire, England, LS9 7TF, United Kingdom
Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, Florida, 33607, United States
Saint Joseph's Regional Medical Center

Paterson, New Jersey, 07503, United States
Saint Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States
San Matteo Hospital

Pavia, 27100, Italy
Seattle Children's Hospital

Seattle, Washington, 98105, United States
Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom
Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States
Spectrum Health at Butterworth Campus

Grand Rapids, Michigan, 49503, United States
Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States
Summerlin Hospital Medical Center

Las Vegas, Nevada, 89144, United States
Technical University Dresden

Dresden, Saxony, 01307, Germany
The Children's Hospital at TriStar Centennial

Nashville, Tennessee, 37203, United States
The Netherlands Cancer Institute

Amsterdam, 1066 CX, Netherlands
The Royal Marsden NHS Foundation Trust - Sutton

Surrey, SM2 5PT, United Kingdom
UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States
UCSF Medical Center-Mission Bay

San Francisco, California, 94158, United States
UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States
USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States
UniversitaetsKlinikum Heidelberg

Heidelberg, 69120, Germany
University Hospital Saint Luc

Brussels, 1200, Belgium
University Hospital Ulm

Ulm, 89081, Germany
University Hospital Zurich

Zurich, 8091, Switzerland
University Medical Center Groningen

Groningen, 9700 GZ, Netherlands
University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany
University of Berlin Charite Campus Benjamin Franklin

Berlin, 12203, Germany
University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States
University of Dusseldorf

Düsseldorf, 40225, Germany
University of Essen

Essen, 45122, Germany
University of Florida Health Science Center - Gainesville

Gainesville, Florida, 32610, United States
University of Illinois

Chicago, Illinois, 60612, United States
University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States
University of Michigan Health - West

Wyoming, Michigan, 49519, United States
University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States
University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232, United States
Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States
Weston Park Hospital

Sheffield, England, S10 2SJ, United Kingdom

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