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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Seminoma; Teratoma; Choriocarcinoma; Germinoma; Germ Cell Tumor; Yolk Sac Tumor; Mixed Germ Cell Tumor; Childhood Teratoma; Malignant Germ Cell Neoplasm; Extragonadal Seminoma; Non-seminomatous Germ Cell Tumor
• Intervention / Treatment: Drug: carboplatin; Drug: paclitaxel; Drug: cisplatin; Drug: ifosfamide; Drug: pegylated G-CSF; Drug: G-CSF; Drug: etoposide phosphate; Procedure: stem cell reinfusion

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.

• Study Type: Interventional
• Enrollment (Actual): 420
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Darren Feldman, MD; Phone Number: 646 422-4491

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Box Hill Hospital
    • Melbourne, Victoria, Australia, 3000
      • Peter Maccallum Cancer Centre
• Belgium
  • Anderlecht, Belgium, 1070
    • Institut Jules Bordet
  • Brussels, Belgium, 1200
    • University Hospital Saint Luc
• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet University Hospital
• France
  • Lyon, France, 69373
    • Centre LEON BERARD
  • Marseille, France, 13273
    • Institut Paoli Calmettes
  • Paris, France, 75970
    • Hopital Tenon/Assistance Publique - Hopitaux de Paris
  • Strasbourg, France, 67091
    • CHRU Strasbourg - Hospital Civil
  • Toulouse, France, 31052
    • Center Claudius Regaud
  • Vandoeuvre-les-Nancy, France, 54511
    • Centre Alexis Vautrin
  • Villejuif, France, 94805
    • Gustave Roussy
• Germany
  • Berlin, Germany, 12203
    • University of Berlin Charite Campus Benjamin Franklin
  • Dusseldorf, Germany, 40225
    • University of Düsseldorf
  • Essen, Germany, 45122
    • University of Essen
  • Hamburg, Germany, 20246
    • University Medical Center Hamburg-Eppendorf
  • Heidelberg, Germany, 69120
    • Universitaetsklinikum Heidelberg
  • Koblenz, Germany, 56068
    • GK-Mittelrhein Saint Martin's
  • Marburg, Germany, 35033
    • Philipps University Marburg
  • Munich, Germany, 80634
    • Rotkreuzklinikum Munchen
  • Nurnberg, Germany, 90419
    • Klinikum Nürnberg Nord
  • Ulm, Germany, 89081
    • University Hospital Ulm
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Technical University Dresden
• Ireland
  • Dublin, Ireland, 8
    • Saint James Hospital
• Italy
  • Busto Arsizio, Italy, 21052
    • Ospedale di Circolo di Busto Arsizio
  • Meldola, Italy, 47014
    • Istituto Scientifico Romagnolo
  • Milano, Italy, 20133
    • Istituto Nazionale Tumori
  • Pavia, Italy, 27100
    • San Matteo Hospital
• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • The Netherlands Cancer Institute
  • Groningen, Netherlands, 9700 GZ
    • University Medical Center Groningen
  • Nijmegen, Netherlands, 6500 HB
    • Radboud University Nijmegen Medical Centre
• Spain
  • Barcelona, Spain, 08025
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 08908
    • Duran i Reynals Hospital-Catalan Institute of Oncology
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Murcia, Spain, 30008
    • Hospital General Universitario Morales Meseguer
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital
  • Geneva, Switzerland, 1211
    • Hôpitaux universitaires de Genève
  • Zurich, Switzerland, 8091
    • University Hospital Zurich
• United Kingdom
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham City Hospital
  • Surrey, United Kingdom, SM2 5PT
    • The Royal Marsden Nhs Foundation Trust - Sutton
  • England
    • London, England, United Kingdom, EC1A 7BE
      • Saint Bartholomew's Hospital
    • Manchester, England, United Kingdom, M20 4BX
      • Christie Hospital
    • Sheffield, England, United Kingdom, S10 2SJ
      • Weston Park Hospital
    • Southampton, England, United Kingdom, SO16 6YD
      • Southampton General Hospital
    • West Yorkshire, England, United Kingdom, LS9 7TF
      • Saint James's University Hospital
  • Scotland
    • Glasgow, Scotland, United Kingdom, G12 0YN
      • Beatson Oncology Center
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Children's Hospital of Alabama
  • California
    • La Jolla, California, United States, 92093
      • UC San Diego Moores Cancer Center
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center
    • Los Angeles, California, United States, 90033
      • USC / Norris Comprehensive Cancer Center
    • Oakland, California, United States, 94611
      • Kaiser Permanente-Oakland
    • Palo Alto, California, United States, 94304
      • Stanford Cancer Institute Palo Alto
    • San Francisco, California, United States, 94158
      • UCSF Medical Center-Mission Bay
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • Alfred I duPont Hospital for Children
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • MedStar Georgetown University Hospital
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida Health Science Center - Gainesville
    • Jacksonville, Florida, United States, 32207
      • Nemours Children's Clinic-Jacksonville
    • Miami, Florida, United States, 33155
      • Nicklaus Children's Hospital
    • Miami, Florida, United States, 33176
      • Miami Cancer Institute
    • Orlando, Florida, United States, 32806
      • Arnold Palmer Hospital for Children
    • Saint Petersburg, Florida, United States, 33701
      • Johns Hopkins All Children's Hospital
    • Tampa, Florida, United States, 33607
      • Saint Joseph's Hospital/Children's Hospital-Tampa
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital/Winship Cancer Institute
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60637
      • University of Chicago Comprehensive Cancer Center
    • Chicago, Illinois, United States, 60612
      • University of Illinois
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Ascension Via Christi Hospitals Wichita
    • Wichita, Kansas, United States, 67214
      • Cancer Center of Kansas - Wichita
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center Jefferson
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Comprehensive Cancer Center
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health at Butterworth Campus
    • Wyoming, Michigan, United States, 49519
      • University of Michigan Health - West
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Children's Hospitals and Clinics of Minnesota - Minneapolis
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Nebraska Methodist Hospital
  • Nevada
    • Las Vegas, Nevada, United States, 89144
      • Summerlin Hospital Medical Center
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memorial Sloan Kettering Basking Ridge
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
    • Middletown, New Jersey, United States, 07748
      • Memorial Sloan Kettering Monmouth
    • Paterson, New Jersey, United States, 07503
      • Saint Joseph's Regional Medical Center
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Commack
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Westchester
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • Uniondale, New York, United States, 11553
      • Memorial Sloan Kettering Nassau
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Lineberger Comprehensive Cancer Center
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center/Levine Cancer Institute
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania/Abramson Cancer Center
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Cancer Institute (UPCI)
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Boiling Springs, South Carolina, United States, 29316
      • Prisma Health Cancer Institute - Spartanburg
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Easley, South Carolina, United States, 29640
      • Prisma Health Cancer Institute - Easley
    • Greenville, South Carolina, United States, 29605
      • Prisma Health Cancer Institute - Faris
    • Greenville, South Carolina, United States, 29607
      • Saint Francis Cancer Center
    • Greenville, South Carolina, United States, 29615
      • Prisma Health Cancer Institute - Eastside
    • Greenville, South Carolina, United States, 29605
      • Prisma Health Cancer Institute - Butternut
    • Greenville, South Carolina, United States, 29601
      • Saint Francis Hospital
    • Greenville, South Carolina, United States, 29605
      • BI-LO Charities Children's Cancer Center
    • Greenville, South Carolina, United States, 29605
      • Prisma Health Greenville Memorial Hospital
    • Greer, South Carolina, United States, 29650
      • Prisma Health Cancer Institute - Greer
    • Seneca, South Carolina, United States, 29672
      • Prisma Health Cancer Institute - Seneca
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Center
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • Saint Jude Children's Research Hospital
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University/Ingram Cancer Center
    • Nashville, Tennessee, United States, 37203
      • The Children's Hospital at TriStar Centennial
  • Texas
    • El Paso, Texas, United States, 79905
      • El Paso Children's Hospital
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital
  • Wisconsin
    • Eau Claire, Wisconsin, United States, 54701
      • Marshfield Medical Center-EC Cancer Center
    • Marshfield, Wisconsin, United States, 54449
      • Marshfield Medical Center-Marshfield
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin
    • Minocqua, Wisconsin, United States, 54548
      • Marshfield Clinic-Minocqua Center
    • Rice Lake, Wisconsin, United States, 54868
      • Marshfield Medical Center-Rice Lake
    • Stevens Point, Wisconsin, United States, 54482
      • Marshfield Medical Center-River Region at Stevens Point
    • Weston, Wisconsin, United States, 54476
      • Marshfield Medical Center - Weston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: Taxol; Drug: cisplatin; IV; Other Names: CDDP; Drug: ifosfamide; IV; Other Names: Ifex®, IFOS; Drug: pegylated G-CSF; IV; Drug: G-CSF; IV
Other: 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: carboplatin; IV; Other Names: Paraplatin®, CBDCA; Drug: paclitaxel; IV; Other Names: Taxol; Drug: ifosfamide; IV; Other Names: Ifex®, IFOS; Drug: pegylated G-CSF; IV; Drug: G-CSF; IV; Drug: etoposide phosphate; IV; Other Names: VePesid®, Toposar®, VP16; Procedure: stem cell reinfusion; surgical procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
overall survival	Up to 36 months post-treatment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Alliance for Clinical Trials in Oncology
• Collaborators: National Cancer Institute (NCI); Cancer Research UK; European Organisation for Research and Treatment of Cancer - EORTC; UNICANCER; Movember Foundation; Institute of Cancer Research (ICR), United Kingdom; Irish Group CTI
• Investigators: Study Chair: Darren Feldman, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

General Publications

• Tan YY, Al-Bubseeree B, Irvine D, MacDonald G, McQuaker G, Parker A, Waterston A, White J. High-Dose Chemotherapy in Relapsed or Refractory Metastatic Germ-Cell Cancer: The Scotland Experience. Clin Genitourin Cancer. 2019 Apr;17(2):125-131. doi: 10.1016/j.clgc.2018.11.013. Epub 2018 Nov 17.

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2015
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: February 20, 2015
• First Submitted That Met QC Criteria: February 25, 2015
• First Posted (Estimated): March 2, 2015

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Pregnancy Complications; Pregnancy Complications, Neoplastic; Trophoblastic Neoplasms; Mesonephroma; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Neoplasms; Neoplasms, Germ Cell and Embryonal; Teratoma; Seminoma; Choriocarcinoma; Endodermal Sinus Tumor; Germinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Alkylating; Alkylating Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Adjuvants, Immunologic; Carboplatin; Etoposide; Etoposide phosphate; Paclitaxel; Ifosfamide; Lenograstim
• Other Study ID Numbers: A031102; U10CA180821 (U.S. NIH Grant/Contract); NCI-2014-01696 (Registry Identifier: NCI Clinical Trial Reporting Program)