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

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ClinicalTrials.gov Identifier: NCT02375204
Recruitment Status : Recruiting
First Posted : March 2, 2015
Last Update Posted : October 23, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
European Organisation for Research and Treatment of Cancer - EORTC
Movember Foundation
Institute of Cancer Research (ICR), United Kingdom
Cancer Research UK
UNICANCER
Irish Group CTI
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
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 Drug: paclitaxel Drug: ifosfamide Drug: cisplatin Drug: pegylated G-CSF Drug: G-CSF Drug: carboplatin Drug: etoposide phosphate Procedure: stem cell reinfusion Phase 3

Detailed Description:

The study is an international collaboration with European sites. Collaborators on the study include the National Cancer Institute, the European Organization for Research and Treatment of Cancer and the Movember Foundation. Randomization will be stratified by region (North America and Europe) and by modified IPFSG (International Prognostic Factor Study Group) risk classification (low, intermediate and high). The primary and secondary objectives are described below.

Primary Objective:

1. To compare the overall survival in patients treated with conventional-dose chemotherapy using the TIP regimen with high-dose chemotherapy (HDCT) plus autologous stem cell transplant (ASCT) using the TI-CE regimen as initial salvage treatment of patients with relapsed or refractory germ cell tumors (GCT)

Secondary Objectives:

  1. To compare the progression-free survival (PFS) of patients treated with initial salvage HDCT with TI-CE versus initial salvage CDCT with TIP
  2. To compare the favorable response rate (FRR) of patients treated with initial salvage HDCT with TI-CE versus initial salvage CDCT with TIP
  3. To compare the toxicity, including treatment-related mortality, associated with high-dose chemotherapy and ASCT using TI-CE compared with conventional-dose chemotherapy using TIP as initial salvage treatment for patients with relapsed or refractory GCT
  4. To prospectively evaluate the IPFSG scoring system as a predictor of outcome to initial salvage therapy in patients with relapsed or refractory GCT. In this trial, randomization will be stratified by a modification of their IPFSG category and we will prospectively evaluate whether or not actual outcomes vary by risk group in the appropriate manner (low risk patients have higher OS than high-risk group).
  5. To evaluate the association between tumor marker decline rates of Alpha-Fetoprotein (AFP) and Human Chorionic Gonadotropin (HCG) with OS and PFS.

Treatment is to continue until disease progression, unacceptable toxicity or completion of all protocol treatment.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2015
Estimated Primary Completion Date : June 2024


Arm Intervention/treatment
Arm A: TIP

Patients will receive treatment for 4 cycles administered every 21 days.

Cycles 1-4 (1 cycle = 21 days)

  • paclitaxel 250 mg/m^2 IV over 24 hours on Day 1 including premedication as defined in the protocol (eg, dexamethasone, diphenhydramine and H2 blocker)
  • ifosfamide 1500 mg/m^2 IV daily on Days 2-5 with mesna protection as defined in the protocol
  • cisplatin 25 mg/m^2 IV daily on Days 2-5
  • pegylated G-CSF 6 mg subcutaneous on Day 6 or 7 or G-CSF as defined in the protocol on Days 6-18

Patients may commence with each Arm A cycle provided they meet the criteria as defined in the protocol.

Drug: paclitaxel
IV
Other Name: Taxol

Drug: ifosfamide
IV
Other Name: Ifex®, IFOS

Drug: cisplatin
IV
Other Name: CDDP

Drug: pegylated G-CSF
IV

Drug: G-CSF
IV

Arm B: TI-CE

Patients will receive treatment for a total of 5 cycles.

Cycles 1-2 (1 cycle = 14 days)

  • paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 including premedication as defined in the protocol (eg, dexamethasone, diphenhydramine and H2 blocker)
  • ifosfamide 2000 mg/m^2 IV daily on Days 1-3 with mesna protection as defined in the protocol
  • G-CSF 10 µg/kg subcutaneously on Days 3-15 (cycle 1) and Days 3-14 (cycle 2) or pegylated G-CSF 6 mg subcutaneous on Day 4 or 6 (cycle 1) and Day 4 or 5 (cycle 2)
  • leukapheresis every 14 days, if there is an inadequate number of CD34+ cells/kg collected in cycle 1

Cycles 3-5 (1 cycle = 21 days)

  • carboplatin daily on Days 1-3
  • etoposide 400 mg/m^2 daily on Days 1-3
  • stem cell reinfusion on day 5
  • pegylated G-CSF 6 mg subcutaneously or G-CSF at approximately 5 µg/kg daily on Days 5-15

Patients may commence with each Arm B cycle provided they meet the criteria as defined in the protocol.

Drug: paclitaxel
IV
Other Name: Taxol

Drug: ifosfamide
IV
Other Name: Ifex®, IFOS

Drug: pegylated G-CSF
IV

Drug: G-CSF
IV

Drug: carboplatin
IV
Other Name: Paraplatin®, CBDCA

Drug: etoposide phosphate
IV
Other Name: VePesid®, Toposar®, VP16

Procedure: stem cell reinfusion
surgical procedure




Primary Outcome Measures :
  1. overall survival [ Time Frame: Up to 36 months post-treatment ]

Secondary Outcome Measures :
  1. progression free survival [ Time Frame: Up to 36 months post-treatment ]
  2. proportion of patients achieving either a complete response (CR) or partial response [ Time Frame: Up to 3 months post-registration ]
  3. treatment related mortality [ Time Frame: Up to 30 days post-treatment ]
  4. number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Up to 3 months post-registration ]
  5. Validation of International Prognostic Factor Study Group stratification system (eg, primary site, prior response, progression free interval) [ Time Frame: Up to 3 years post-registration ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02375204


Contacts
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Contact: Darren Feldman, MD 646 422-4491

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Locations
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United States, California
UC San Diego Moores Cancer Center Active, not recruiting
La Jolla, California, United States, 92093
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Site Public Contact    909-558-3375      
Principal Investigator: Albert Kheradpour         
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Site Public Contact    323-865-0451      
Principal Investigator: James S. Hu         
Kaiser Permanente-Oakland Recruiting
Oakland, California, United States, 94611
Contact: Site Public Contact    877-642-4691    Kpoct@kp.org   
Principal Investigator: Laura A. Campbell         
Stanford Cancer Institute Palo Alto Recruiting
Palo Alto, California, United States, 94304
Contact: Site Public Contact    650-498-7061    ccto-office@stanford.edu   
Principal Investigator: Sandy Srinivas         
UCSF Medical Center-Mission Bay Recruiting
San Francisco, California, United States, 94158
Contact: Site Public Contact    877-827-3222      
Principal Investigator: Arun A. Rangaswami         
United States, Florida
University of Florida Health Science Center - Gainesville Recruiting
Gainesville, Florida, United States, 32610
Contact: Site Public Contact    352-273-8010    cancer-center@ufl.edu   
Principal Investigator: William B. Slayton         
Nicklaus Children's Hospital Recruiting
Miami, Florida, United States, 33155
Contact: Site Public Contact    888-624-2778      
Principal Investigator: Enrique A. Escalon         
Johns Hopkins All Children's Hospital Active, not recruiting
Saint Petersburg, Florida, United States, 33701
Saint Joseph's Hospital/Children's Hospital-Tampa Recruiting
Tampa, Florida, United States, 33607
Contact: Site Public Contact    813-356-7168    Katelynn.Colgain@baycare.org   
Principal Investigator: Dana A. Obzut         
United States, Georgia
Emory University Hospital/Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Site Public Contact    404-778-1868      
Principal Investigator: Bradley C. Carthon         
United States, Illinois
Northwestern University Active, not recruiting
Chicago, Illinois, United States, 60611
Rush University Medical Center Suspended
Chicago, Illinois, United States, 60612
University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Site Public Contact    312-355-3046      
Principal Investigator: Mary L. Schmidt         
University of Chicago Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Site Public Contact    773-702-8222    cancerclinicaltrials@bsd.uchicago.edu   
Principal Investigator: Walter M. Stadler         
United States, Kansas
Ascension Via Christi Hospitals Wichita Recruiting
Wichita, Kansas, United States, 67214
Contact: Site Public Contact    800-362-0070    Keisha.humphries@ascension.org   
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Wichita Recruiting
Wichita, Kansas, United States, 67214
Contact: Site Public Contact    316-268-5374    Keisha.humphries@ascension.org   
Principal Investigator: Shaker R. Dakhil         
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Site Public Contact    877-442-3324      
Principal Investigator: A. L. Frazier         
United States, Michigan
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Site Public Contact    800-865-1125      
Principal Investigator: David C. Smith         
Spectrum Health at Butterworth Campus Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Site Public Contact    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
Metro Health Hospital Suspended
Wyoming, Michigan, United States, 49519
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Site Public Contact    612-813-5193      
Principal Investigator: Michael K. Richards         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Site Public Contact    855-776-0015      
Principal Investigator: Brian A. Costello         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Site Public Contact    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Joel Picus         
United States, Nebraska
Nebraska Methodist Hospital Recruiting
Omaha, Nebraska, United States, 68114
Contact: Site Public Contact    402-354-5144      
Principal Investigator: Ralph J. Hauke         
United States, New Jersey
Memorial Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Site Public Contact    212-639-7592      
Principal Investigator: Darren R. Feldman         
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Site Public Contact    201-996-2879      
Principal Investigator: Burton E. Appel         
Memorial Sloan Kettering Monmouth Suspended
Middletown, New Jersey, United States, 07748
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Site Public Contact    800-767-9355    askroswell@roswellpark.org   
Principal Investigator: Ellis G. Levine         
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Site Public Contact    212-639-7592      
Principal Investigator: Darren R. Feldman         
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Site Public Contact    212-639-7592      
Principal Investigator: Darren R. Feldman         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Site Public Contact    212-639-7592      
Principal Investigator: Darren R. Feldman         
Memorial Sloan Kettering Nassau Recruiting
Uniondale, New York, United States, 11553
Contact: Site Public Contact    212-639-7592      
Principal Investigator: Darren R. Feldman         
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Site Public Contact    877-668-0683    cancerclinicaltrials@med.unc.edu   
Principal Investigator: Matthew I. Milowsky         
Carolinas Medical Center/Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Site Public Contact    800-804-9376      
Principal Investigator: Joel A. Kaplan         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Site Public Contact    513-636-2799    cancer@cchmc.org   
Principal Investigator: James I. Geller         
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Site Public Contact    800-293-5066    Jamesline@osumc.edu   
Principal Investigator: J. P. Monk         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Site Public Contact    405-271-8777    ou-clinical-trials@ouhsc.edu   
Principal Investigator: Abhishek Tripathi         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Site Public Contact    267-425-5544    CancerTrials@email.chop.edu   
Principal Investigator: Frank M. Balis         
University of Pennsylvania/Abramson Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Site Public Contact    800-474-9892      
Principal Investigator: David J. Vaughn         
University of Pittsburgh Cancer Institute (UPCI) Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Site Public Contact    412-647-8073      
Principal Investigator: Leonard J. Appleman         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Site Public Contact    401-444-1488      
Principal Investigator: Jennifer J. Greene Welch         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Site Public Contact    843-792-9321    hcc-clinical-trials@musc.edu   
Principal Investigator: Jacqueline M. Kraveka         
Prisma Health Cancer Institute - Easley Recruiting
Easley, South Carolina, United States, 29640
Contact: Site Public Contact    864-522-2066    kim.williams3@prismahealth.org   
Principal Investigator: Jeffrey K. Giguere         
Saint Francis Hospital Recruiting
Greenville, South Carolina, United States, 29601
Contact: Site Public Contact    864-603-6213    meissa_beckman@bshsi.org   
Principal Investigator: Robert D. Siegel         
Prisma Health Cancer Institute - Butternut Recruiting
Greenville, South Carolina, United States, 29605
Contact: Site Public Contact    864-522-2066    kim.williams3@prismahealth.org   
Principal Investigator: Jeffrey K. Giguere         
Prisma Health Cancer Institute - Faris Recruiting
Greenville, South Carolina, United States, 29605
Contact: Site Public Contact    864-522-2066    kim.williams3@prismahealth.org   
Principal Investigator: Jeffrey K. Giguere         
Prisma Health Greenville Memorial Hospital Recruiting
Greenville, South Carolina, United States, 29605
Contact: Site Public Contact    864-522-2066    kim.williams3@prismahealth.org   
Principal Investigator: Jeffrey K. Giguere         
Saint Francis Cancer Center Recruiting
Greenville, South Carolina, United States, 29607
Contact: Site Public Contact    864-603-6213    meissa_beckman@bshsi.org   
Principal Investigator: Robert D. Siegel         
Prisma Health Cancer Institute - Eastside Recruiting
Greenville, South Carolina, United States, 29615
Contact: Site Public Contact    864-522-2066    kim.williams3@prismahealth.org   
Principal Investigator: Jeffrey K. Giguere         
Prisma Health Cancer Institute - Greer Recruiting
Greer, South Carolina, United States, 29650
Contact: Site Public Contact    864-522-2066    kim.williams3@prismahealth.org   
Principal Investigator: Jeffrey K. Giguere         
Prisma Health Cancer Institute - Seneca Recruiting
Seneca, South Carolina, United States, 29672
Contact: Site Public Contact    864-522-2066    kim.williams3@prismahealth.org   
Principal Investigator: Jeffrey K. Giguere         
Prisma Health Cancer Institute - Spartanburg Recruiting
Spartanburg, South Carolina, United States, 29307
Contact: Site Public Contact    864-522-2066    kim.williams3@prismahealth.org   
Principal Investigator: Jeffrey K. Giguere         
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Site Public Contact    866-278-5833    info@stjude.org   
Principal Investigator: Alberto S. Pappo         
The Children's Hospital at TriStar Centennial Recruiting
Nashville, Tennessee, United States, 37203
Contact: Site Public Contact    615-342-1919      
Principal Investigator: Haydar A. Frangoul         
Vanderbilt University/Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Site Public Contact    800-811-8480      
Principal Investigator: Scott C. Borinstein         
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Site Public Contact    877-632-6789    askmdanderson@mdanderson.org   
Principal Investigator: Matthew T. Campbell         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Site Public Contact    866-987-2000      
Principal Investigator: Douglas S. Hawkins         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Site Public Contact    414-805-3666      
Principal Investigator: Deepak Kilari         
Australia, New South Wales
Royal Prince Alfred Hospital Recruiting
Camperdown, New South Wales, Australia, 2050
Contact: Site Public Contact    61 (02) 9515 6766      
Principal Investigator: Peter S. Grimison         
Australia, Queensland
Princess Alexandra Hospital Recruiting
Woolloongabba, Queensland, Australia, 4102
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Euan T. Walpole         
Australia, Victoria
Box Hill Hospital Recruiting
Box Hill, Victoria, Australia, 3128
Contact: Site Public Contact       ehcs@monash.edu   
Principal Investigator: Ian D. Davis         
Peter MacCallum Cancer Centre Recruiting
Melbourne, Victoria, Australia, 3000
Contact: Site Public Contact    61 3 9656 1521      
Principal Investigator: Guy C. Toner         
Belgium
University Hospital Saint Luc Suspended
Brussels, Belgium, 1200
Institut Jules Bordet Recruiting
Bruxelles, Belgium, 1000
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Thierry L. Gil         
Denmark
Rigshospitalet University Hospital Recruiting
Copenhagen, Denmark, 2100
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Gedske Daugaard         
France
Centre Leon Berard Recruiting
Lyon, France, 69373
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Aude Flechon         
Institut Paoli Calmettes Recruiting
Marseille, France, 13273
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Gwenaelle Gravis         
Hopital Tenon Recruiting
Paris, France, 75970
Contact: Site Public Contact    33 (0)1 56 01 63 73      
Principal Investigator: Jean-Pierre Lotz         
CHRU Strasbourg - Hospital Civil Recruiting
Strasbourg, France, 67091
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Philippe BARTHELEMY         
Center Claudius Regaud Recruiting
Toulouse, France, 31052
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: christine Chevreau         
Gustave Roussy Recruiting
Villejuif, France, 94805
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Cristina Castilla Llorente         
Germany
Technical University Dresden Recruiting
Dresden, Saxony, Germany, 01307
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Stephan Richter         
University of Berlin Charite Campus Benjamin Franklin Recruiting
Berlin, Germany, 12203
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Sebastian Ochsenreither         
University of Dusseldorf Recruiting
Dusseldorf, Germany, 40225
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Anja J. Lorch         
University of Essen Recruiting
Essen, Germany, 45122
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Martin Schuler         
University Medical Center Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Carsten Bokemeyer         
GK-Mittelrhein Saint Martin's Recruiting
Koblenz, Germany, 56068
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Dirk Niemann         
Philipps University Marburg Recruiting
Marburg, Germany, 35033
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Andreas Burchert         
Rotkreuzklinikum Munchen Recruiting
Munich, Germany, 80634
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Marcus Hentrich         
Klinikum Nurnberg Nord Recruiting
Nurnberg, Germany, 90419
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Kerstin Schaefer-Eckart         
University Hospital Ulm Recruiting
Ulm, Germany, 89081
Contact: Site Public Contact    49 731 500-56022    studienzentrum.cccu@uniklinik-ulm.de   
Principal Investigator: Miriam Kull         
Ireland
Saint James Hospital Recruiting
Dublin, Ireland, 8
Contact: Site Public Contact    353 1 4162168      
Principal Investigator: Dearbhaile M. O'Donnell         
Italy
Ospedale di Circolo di Busto Arsizio Suspended
Busto Arsizio, Italy, 21052
Istituto Scientifico Romagnolo Recruiting
Meldola, Italy, 47014
Contact: Site Public Contact       info@irst.emr.it   
Principal Investigator: Ugo De Giorgi         
Istituto Nazionale Tumori Recruiting
Milano, Italy, 20133
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Andrea Necchi         
San Matteo Hospital Recruiting
Pavia, Italy, 27100
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Paolo Pedrazzoli         
Netherlands
The Netherlands Cancer Institute Recruiting
Amsterdam, Netherlands, 1066 CX
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Jan M. Kerst         
University Medical Center Groningen Suspended
Groningen, Netherlands, 9700 GZ
Radboud University Nijmegen Medical Centre Suspended
Nijmegen, Netherlands, 6500 HB
Spain
Hospital De La Santa Creu I Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Site Public Contact    34 93 556 56 49      
Principal Investigator: Jose Pablo Maroto Rey         
Duran i Reynals Hospital-Catalan Institute of Oncology Recruiting
Barcelona, Spain, 08908
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Javier Garcia del Muro         
Hospital General Universitario Morales Meseguer Recruiting
Murcia, Spain, 30008
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Enrique Gonzalez-Billalabeitia         
Switzerland
Inselspital Recruiting
Bern, Switzerland, 3010
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Thomas Pabst         
Hopitaux Universitaires de Geneve Recruiting
Geneva, Switzerland, 1211
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Anna Patrikidou         
University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Christian Britschgi         
United Kingdom
Saint Bartholomew's Hospital Recruiting
London, England, United Kingdom, EC1A 7BE
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Jonathan Shamash         
Christie Hospital Recruiting
Manchester, England, United Kingdom, M20 4BX
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Richard Welch         
Weston Park Hospital Recruiting
Sheffield, England, United Kingdom, S10 2SJ
Contact: Site Public Contact    44114 226 5709      
Principal Investigator: Linda S. Evans         
Southampton General Hospital Recruiting
Southampton, England, United Kingdom, SO16 6YD
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Matthew J. Wheater         
Saint James's University Hospital Recruiting
West Yorkshire, England, United Kingdom, LS9 7TF
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Johnathan K. Joffe         
Beatson Oncology Center Suspended
Glasgow, Scotland, United Kingdom, G12 0YN
Nottingham City Hospital Recruiting
Nottingham, United Kingdom, NG5 1PB
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Ivo M. Hennig         
The Royal Marsden NHS Foundation Trust - Sutton Recruiting
Surrey, United Kingdom, SM2 5PT
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Robert A. Huddart         
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
European Organisation for Research and Treatment of Cancer - EORTC
Movember Foundation
Institute of Cancer Research (ICR), United Kingdom
Cancer Research UK
UNICANCER
Irish Group CTI
Investigators
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Study Chair: Darren Feldman, MD Memorial Sloan Kettering Cancer Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT02375204     History of Changes
Other Study ID Numbers: A031102
U10CA180821 ( U.S. NIH Grant/Contract )
NCI-2014-01696 ( Registry Identifier: NCI Clinical Trial Reporting Program )
First Posted: March 2, 2015    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Neoplasms, Germ Cell and Embryonal
Teratoma
Endodermal Sinus Tumor
Seminoma
Choriocarcinoma
Germinoma
Neoplasms
Neoplasms by Histologic Type
Mesonephroma
Trophoblastic Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Pregnancy Complications, Neoplastic
Pregnancy Complications
Paclitaxel
Etoposide
Albumin-Bound Paclitaxel
Cisplatin
Carboplatin
Etoposide phosphate
Ifosfamide
Isophosphamide mustard
Lenograstim
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action