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Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2009
First Received: January 27, 2003   Last Updated: November 7, 2009   History of Changes
Sponsor: Children's Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00053352
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them after surgery, may kill any remaining tumor cells following surgery. It is not yet known whether combination chemotherapy is effective in decreasing the recurrence of childhood germ cell tumors.

PURPOSE: This phase III trial is studying surgery followed by combination chemotherapy to see how well it works in treating children with germ cell tumors that are not located in the head.


Condition Intervention Phase
Childhood Germ Cell Tumor
Extragonadal Germ Cell Tumor
Ovarian Cancer
 Biological: bleomycin sulfate
Drug: cisplatin
Drug: etoposide
Procedure: conventional surgery
 Phase III

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase III Study Of Reduced Therapy In The Treatment Of Children With Low And Intermediate Risk Extracranial Germ Cell Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer Surgery
Drug Information available for: Bleomycin Cisplatin Etoposide Etoposide phosphate Bleomycin sulfate
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Event-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 306
Study Start Date: November 2003
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine whether children with newly diagnosed low- or intermediate-risk extracranial germ cell tumors (GCTs) can maintain a 3-year event-free survival of at least 92% (for intermediate-risk tumors only) and overall survival of at least 95% (both low-risk and intermediate-risk tumors) after treatment with surgery followed by compressed cisplatin, etoposide, and bleomycin.
  • Determine the percentage of patients with stage I ovarian or stage I testicular GCTs for whom chemotherapy can be eliminated.
  • Determine the percentage of intermediate-risk patients who require only 3 courses of therapy.
  • Determine the acute toxic effects of compressed therapy in these patients.
  • Determine the long-term sequelae in patients treated with this regimen.
  • Determine the number of hospital days and total drug doses required for patients treated with compressed therapy.
  • Compare the number of protocol-directed treatment days used in CCG-8882 vs the number of treatment days used in this study.
  • Determine the cytogenetic and molecular genetic features in patients treated with this regimen.

OUTLINE: Patients are stratified according to disease risk (low vs intermediate).

  • Surgery: Patients undergo surgical resection.

    • Low-risk disease: Patients with gonadal primaries and no evidence of disease after surgery undergo monitoring for disease progression. Patients who remain disease free receive no further treatment. Patients who have disease progression after surgery receive compressed induction chemotherapy.
    • Intermediate-risk disease: After surgery, patients proceed to compressed induction chemotherapy.
  • Compressed induction therapy: Patients receive cisplatin IV over 90 minutes and etoposide IV over 90 minutes on days 1-3 and bleomycin IV over 10 minutes on day 1. Treatment repeats every 3 weeks for 3 courses (weeks 0, 3, and 6).

After completion of compressed induction chemotherapy, patients who have no change in disease status or disease progression are removed from study. Patients with no evidence of disease receive no further therapy. Patients with a partial response or who have abnormal tumor markers proceed to second-look surgery and/or compressed consolidation chemotherapy.

  • Second-look surgery: Patients undergo surgical resection of residual tumor. After surgery, patients who are in pathologic complete response and have normal tumor markers receive no further therapy. Patients who remain with a partial response after surgery receive compressed consolidation chemotherapy.
  • Compressed consolidation chemotherapy: Patients receive cisplatin, etoposide, and bleomycin as in induction chemotherapy in weeks 10, 13, and 16.

Patients are followed monthly for 6 months, every 3 months for 6 months, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 306 patients (126 with low-risk disease and 180 with intermediate-risk disease) will be accrued for this study within 6 years.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary extracranial germ cell tumor (GCT), including one of the following types:

    • Yolk sac tumor
    • Embryonal carcinoma
    • Choriocarcinoma

    • Mixed germ cell tumor

      • Immature teratoma*
      • Mature teratoma*
      • Dysgerminoma* NOTE: *Mixed with yolk sac tumor, embryonal carcinoma or choriocarcinoma

  • Patients with any of the following diagnosis are not allowed:

    • Intracranial germ cell tumors
    • Pure mature or immature teratoma
    • Pure dysgerminoma
    • Pure seminoma

  • Low-risk disease

    • Stage I malignant testicular GCT
    • Stage I malignant ovarian GCT

  • Intermediate-risk disease

    • Stage II, III, or IV malignant testicular GCT
    • Stage II or III malignant ovarian GCT
    • Stage I or II extragonadal GCT
  • Alpha-fetoprotein and beta human chorionic gonadotropin tumor markers known
  • Must be enrolled within 6 weeks of original diagnostic surgery

PATIENT CHARACTERISTICS:

Age

  • 21 and under at diagnosis (under 15 for patients with primary testicular tumors)

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Creatinine normal for age OR
  • Isotope glomerular filtration rate at least 50% normal OR
  • Creatinine clearance at least 60 mL/min

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy

Surgery

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00053352

  Hide Study Locations
Locations
United States, Alabama
UAB Comprehensive Cancer Center Recruiting
Birmingham, Alabama, United States, 35294
Contact: Clinical Trials Office - UAB Comprehensive Cancer Center     205-934-0309        
United States, Arizona
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016-7710
Contact: Jessica L. Boklan     602-546-0920        
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Clinical Trial Office - Arkansas Cancer Research Center at Uni     501-686-8274        
United States, California
Children's Hospital and Research Center Oakland Recruiting
Oakland, California, United States, 94609
Contact: Clinical Trial Office - Children's Hospital and Research Cente     510-450-7600        
Loma Linda University Cancer Institute at Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Clinical Trials Office - Loma Linda University Cancer Institut     909-558-3375        
Childrens Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Leo Mascarenhas     323-361-2529        
Children's Hospital of Orange County Recruiting
Orange, California, United States, 92868
Contact: Violet Shen     714-532-8636        
Kaiser Permanente Medical Center - Oakland Recruiting
Sacramento, California, United States, 95825
Contact: Vincent Kiley     916-973-7331        
Children's Hospital Central California Recruiting
Madera, California, United States, 93638-8762
Contact: Vonda L. Crouse     559-353-5480        
Rady Children's Hospital - San Diego Recruiting
San Diego, California, United States, 92123-4282
Contact: Clinical Trials Office - Rady Children's Hospital - San Diego     858-966-5934        
Southern California Permanente Medical Group Recruiting
Downey, California, United States, 90242-2814
Contact: Robert Cooper     323-783-5307        
Stanford Cancer Center Recruiting
Stanford, California, United States, 94305-5824
Contact: Clinical Trials Office - Stanford Cancer Center     650-498-7061     cctoffice@stanford.edu    
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi     877-827-3222        
United States, Colorado
Children's Hospital Center for Cancer and Blood Disorders Recruiting
Aurora, Colorado, United States, 80045
Contact: Kelly Maloney     720-777-6673        
United States, Connecticut
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center Recruiting
Farmington, Connecticut, United States, 06360-2875
Contact: Clinical Trials Office - Carole and Ray Neag Comprehensive Can     800-579-7822        
United States, Delaware
Alfred I. duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Clinical Trials Office - Alfred I. duPont Hospital for Childre     302-651-5755        
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010-2970
Contact: Clinical Trials Office - Children's National Medical Center     202-884-2549        
United States, Florida
All Children's Hospital Recruiting
St. Petersburg, Florida, United States, 33701
Contact: Jerry Barbosa     727-767-4176        
Baptist-South Miami Regional Cancer Program Recruiting
Miami, Florida, United States, 33176
Contact: Doured Daghistani     305-274-1662        
Broward General Medical Center Cancer Center Recruiting
Fort Lauderdale, Florida, United States, 33316
Contact: Clinical Trials Office - Broward General Medical Center Cancer     954-355-5346        
Kaplan Cancer Center at St. Mary's Medical Center Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Narayana Gowda     561-844-6363        
Lee Cancer Care of Lee Memorial Health System Recruiting
Fort Myers, Florida, United States, 33901
Contact: Clinical Trials Office - Lee Cancer Care of Lee Memorial Healt     877-680-0008        
M.D. Anderson Cancer Center at Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Contact Person     407-648-3800        
Memorial Cancer Institute at Memorial Regional Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Clinical Trials Office - Memorial Cancer Institute     954-985-3443        
St. Joseph's Cancer Institute at St. Joseph's Hospital Recruiting
Tampa, Florida, United States, 33607
Contact: Clinical Trials Office - St. Joseph's Cancer Institute     800-882-4123        
Nemours Children's Clinic - Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Contact Person     407-650-7230        
Nemours Children's Clinic Recruiting
Jacksonville, Florida, United States, 32207
Contact: Eric Sandler     904-390-3793        
Sacred Heart Cancer Center at Sacred Heart Hospital Recruiting
Pensacola, Florida, United States, 32504
Contact: Clinical Trials Office - Sacred Heart Cancer Center     850-416-4611        
Miami Children's Hospital Recruiting
Miami, Florida, United States, 33155
Contact: Enrique Escalon     305-662-8360x4960        
University of Florida Shands Cancer Center Recruiting
Gainesville, Florida, United States, 32610-0232
Contact: Clinical Trials Office - University of Florida Shands Cancer C     888-254-7581        
United States, Georgia
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Recruiting
Savannah, Georgia, United States, 31403-3089
Contact: Clinical Trials Office - Curtis and Elizabeth Anderson Cancer     912-350-8568        
MBCCOP - Medical College of Georgia Cancer Center Recruiting
Augusta, Georgia, United States, 30912-3730
Contact: Colleen McDonough     706-721-3626        
Winship Cancer Institute of Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Howard M. Katzenstein     404-785-0853        
United States, Hawaii
Cancer Research Center of Hawaii Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Clinical Trials Office - Cancer Research Center of Hawaii     808-586-2979        
United States, Idaho
Mountain States Tumor Institute at St. Luke's Regional Medical Center Recruiting
Boise, Idaho, United States, 83712-6297
Contact: Eugenia Chang     208-381-2731        
United States, Illinois
Advocate Lutheran General Cancer Care Center Recruiting
Park Ridge, Illinois, United States, 60068-1174
Contact: Clinical Trials Office - Advocate Lutheran General Cancer Care     847-384-3621        
Cardinal Bernardin Cancer Center at Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center     708-226-4357        
Children's Memorial Hospital - Chicago Recruiting
Chicago, Illinois, United States, 60614
Contact: David O. Walterhouse     773-755-6514        
Saint Jude Midwest Affiliate Recruiting
Peoria, Illinois, United States, 61637
Contact: Stephen D. Smith     309-624-4945        
Simmons Cooper Cancer Institute Recruiting
Springfield, Illinois, United States, 62794-9677
Contact: Clinical Trials Office - Simmons Cooper Cancer Institute     217-545-7929        
United States, Indiana
St. Vincent Indianapolis Hospital Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Clinical Trials Office - St. Vincent Indianapolis Hospital     317-338-2194        
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160-7357
Contact: Clinical Trials Office - Kansas Masonic Cancer Research Instit     913-588-4709        
United States, Kentucky
Kosair Children's Hospital Recruiting
Louisville, Kentucky, United States, 40232
Contact: Clinical Trials Office - Kosair Children's Hospital     502-629-5500     CancerResource@nortonhealthcare.org    
Lucille P. Markey Cancer Center at University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536-0093
Contact: Clinical Trials Office - Markey Cancer Center at University of     859-257-3379        
United States, Maryland
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital Recruiting
Baltimore, Maryland, United States, 21215
Contact: Joseph Wiley     410-601-5864        
United States, Massachusetts
Baystate Regional Cancer Program at D'Amour Center for Cancer Care Recruiting
Springfield, Massachusetts, United States, 01199-0001
Contact: Satkiran S. Grewal     413-794-5316        
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Holcombe Grier     617-632-3971        
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Clinical Trials Office - Massachusetts General Hospital     877-726-5130        
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201-1379
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute     313-576-9363        
Breslin Cancer Center at Ingham Regional Medical Center Recruiting
Lansing, Michigan, United States, 48910
Contact: Clinical Trials Office - Breslin Cancer Center at Ingham Regio     517-334-2765        
Butterworth Hospital at Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503-2560
Contact: David S. Dickens     616-391-2086        
C.S. Mott Children's Hospital at University of Michigan Medical Center Recruiting
Ann Arbor, Michigan, United States, 48109-0286
Contact: Clinical Trials Office - C.S. Mott Children's Hospital     800-865-1125        
CCOP - Kalamazoo Recruiting
Kalamazoo, Michigan, United States, 49007-5341
Contact: Leonard A. Mattano, Jr.     269-341-6350        
Hurley Medical Center Recruiting
Flint, Michigan, United States, 48503
Contact: Clinical Trials Office - Hurley Medical Center     810-762-8057        
Van Elslander Cancer Center at St. John Hospital and Medical Center Recruiting
Grosse Pointe Woods, Michigan, United States, 48236
Contact: Clincial Trials Office - Van Elslander Cancer Center at St. Jo     313-343-3166        
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Clinical Trials Office - Children's Hospitals and Clinics of M     612-813-5193        
Masonic Cancer Center at University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Clinical Trials Office - Masonic Cancer Center at University o     612-624-2620        
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
United States, Mississippi
University of Mississippi Cancer Clinic Recruiting
Jackson, Mississippi, United States, 39216-4505
Contact: Gail C. Megason     601-984-5220        
United States, Missouri
Cardinal Glennon Children's Hospital Recruiting
St. Louis, Missouri, United States, 63104
Contact: William S. Ferguson     314-577-5638        
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Maxine Hetherington     816-234-3265        
Ellis Fischel Cancer Center at University of Missouri - Columbia Recruiting
Columbia, Missouri, United States, 65203
Contact: Clinical Trial Office - Ellis Fischel Cancer Center     573-882-7440        
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
St. Louis, Missouri, United States, 63110
Contact: Robert J. Hayashi     314-454-4118        
United States, Nevada
Sunrise Hospital and Medical Center Recruiting
Las Vegas, Nevada, United States, 89109-2306
Contact: Jonathan Bernstein     702-732-1493        
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756-0002
Contact: Clinical Trials Office - Norris Cotton Cancer Center     603-650-7609     cancerhelp@dartmouth.edu    
United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Clinical Trials Office - Cancer Institute of New Jersey     732-235-8675        
Hackensack University Medical Center Cancer Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Clinical Trials Office - Hackensack University Medical Center     201-996-2879        
St. Joseph's Hospital and Medical Center Recruiting
Paterson, New Jersey, United States, 07503
Contact: Mary Ann Bonilla     973-754-3349        
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87131-5636
Contact: Clinical Trials Office - University of New Mexico Cancer Cente     505-272-6972        
United States, New York
Schneider Children's Hospital Recruiting
New Hyde Park, New York, United States, 11040
Contact: Arlene Redner     718-470-3460        
Albert Einstein Cancer Center at Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10461
Contact: Clinical Trials Office - Albert Einstein Cancer Center at Albe     718-904-2730     aecc@aecom.yu.edu    
Brooklyn Hospital Center Recruiting
Brooklyn, New York, United States, 11201-5493
Contact: Swayamprabha Sadanandan     718-250-6074        
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C     212-305-8615        
James P. Wilmot Cancer Center at University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Barbara L. Asselin     585-275-2981        
Maimonides Cancer Center at Maimonides Medical Center Recruiting
Brooklyn, New York, United States, 11219
Contact: Ludovico Guarini     718-283-8173        
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Fevzi Ozkaynak     914-493-7997        
NYU Cancer Institute at New York University Medical Center Recruiting
New York, New York, United States, 10016
Contact: Elizabeth Raetz     212-263-9908        
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263-0001
Contact: Clinical Trials Office - Roswell Park Cancer Institute     877-275-7724        
Albany Medical Center Hospital Recruiting
Albany, New York, United States, 12208-3419
Contact: Vikramjit S. Kanwar     518-262-5513x25265        
SUNY Upstate Medical University Hospital Recruiting
Syracuse, New York, United States, 13210
Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi     315-464-5476        
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Mark E. Weinblatt     516-663-9400        
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28232-2861
Contact: Clinical Trials Office - Blumenthal Cancer Center at Carolinas     704-355-2884        
Duke Comprehensive Cancer Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Clinical Trials Office - Duke Comprehensive Cancer Center     888-275-3853        
Mission Hospitals - Memorial Campus Recruiting
Asheville, North Carolina, United States, 28801
Contact: Clinical Trials Office - Mission Hospitals - Memorial Campus     828-213-4150        
Presbyterian Cancer Center at Presbyterian Hospital Recruiting
Charlotte, North Carolina, United States, 28233-3549
Contact: Clinical Trials Office - Presbyterian Cancer Center at Presbyt     704-384-5369        
Wake Forest University Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive     336-713-6771        
United States, North Dakota
CCOP - MeritCare Hospital Recruiting
Fargo, North Dakota, United States, 58122
Contact: Nathan Kobrinsky     701-234-7544        
United States, Ohio
Akron Children's Hospital Recruiting
Akron, Ohio, United States, 44308-1062
Contact: Clinical Trials Office - Akron Children's Hospital     330-543-3193        
Children's Medical Center - Dayton Recruiting
Dayton, Ohio, United States, 45404-1815
Contact: Emmett Broxson     937-641-3111        
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229-3039
Contact: Clinical Trials Office - Cincinnati Children's Hospital Medica     513-636-2799        
Cleveland Clinic Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente     866-223-8100        
Medical University of Ohio Cancer Center Recruiting
Toledo, Ohio, United States, 43614
Contact: Clinical Trials Office - Medical University of Ohio Cancer Cen     419-383-6583        
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205-2696
Contact: Amanda Termuhlen     614-722-3552        
Rainbow Babies and Children's Hospital Recruiting
Cleveland, Ohio, United States, 44106-5000
Contact: Susan Wiersma     216-844-3345        
Toledo Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Clinical Trials Office - Toledo Hospital     419-824-1842        
United States, Oklahoma
Oklahoma University Cancer Institute Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Rene Y. McNall-Knapp     405-271-5311        
United States, Oregon
Knight Cancer Institute at Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Clinical Trials Office - Knight Cancer Institute at Oregon Hea     503-494-1080     trials@ohsu.edu    
Legacy Emanuel Hospital and Health Center and Children's Hospital Recruiting
Portland, Oregon, United States, 97227
Contact: Clinical Trials Office - Legacy Emanuel Hospital and Health Ce     503-413-8199        
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104-9786
Contact: Peter Adamson     215-590-6359        
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Clinical Trials Office - Children's Hospital of Pittsburgh     412-692-5573        
Geisinger Cancer Institute at Geisinger Health Recruiting
Danville, Pennsylvania, United States, 17822-0001
Contact: Clinical Trials Office - Geisinger Cancer Institute     570-271-5251        
Lehigh Valley Hospital - Muhlenberg Recruiting
Bethlehem, Pennsylvania, United States, 18107
Contact: Philip M. Monteleone     484-884-3347        
Penn State Cancer Institute at Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033-0850
Contact: Clinical Trials Office - Penn State Cancer Institute at Milton     717-531-3779     CTO@hmc.psu.edu    
St. Christopher's Hospital for Children Recruiting
Philadelphia, Pennsylvania, United States, 19134-1095
Contact: Clinical Trials Office - St. Christopher's Hospital for Childr     215-427-8991        
United States, South Carolina
Greenville Hospital Cancer Center Recruiting
Greenville, South Carolina, United States, 29605
Contact: Clinical Trials Office - Greenville Hospital Cancer Center     864-241-6251        
Hollings Cancer Center at Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Clinical Trials Office - Hollings Cancer Center at Medical Uni     843-792-9321        
Palmetto Health South Carolina Cancer Center Recruiting
Columbia, South Carolina, United States, 29203
Contact: Clinical Trials Office - Palmetto Health South Carolina Cancer     803-434-3680        
United States, South Dakota
Sanford Cancer Center at Sanford USD Medical Center Recruiting
Sioux Falls, South Dakota, United States, 57117-5039
Contact: Clinical Trials Office - Sanford Cancer Center     605-328-1367        
United States, Tennessee
East Tennessee Children's Hospital Recruiting
Knoxville, Tennessee, United States, 37901
Contact: Ray C. Pais     865-541-8266        
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center     800-811-8480        
United States, Texas
Baylor University Medical Center - Houston Recruiting
Houston, Texas, United States, 77030-2399
Contact: Alberto Pappo     832-822-4248        
CCOP - Scott and White Hospital Recruiting
Temple, Texas, United States, 76508
Contact: Arlynn F. Mulne     254-724-2006        
Cook Children's Medical Center - Fort Worth Recruiting
Fort Worth, Texas, United States, 76104
Contact: Clinical Trials Office - Cook's Children's Medical Center     682-885-2103        
Covenant Children's Hospital Recruiting
Lubbock, Texas, United States, 79410
Contact: Latha Prasannan     806-725-4840        
Methodist Children's Hospital of South Texas Recruiting
San Antonio, Texas, United States, 78229-3993
Contact: Donna Wall     210-575-7268        
Driscoll Children's Hospital Recruiting
Corpus Christi, Texas, United States, 78411
Contact: Clinical Trials Office - Driscoll Children's Hospital     361-694-5311        
M. D. Anderson Cancer Center at University of Texas Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U     713-792-3245        
Medical City Dallas Hospital Recruiting
Dallas, Texas, United States, 75230
Contact: Carl Lenarsky     972-566-6647x4439        
Dell Children's Medical Center of Central Texas Recruiting
Austin, Texas, United States, 78723
Contact: Clinical Trials Office - Dell Children's Medical Center of Cen     512-324-8022        
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a     866-460-4673; 214-648-7097        
Texas Tech University Health Sciences Center School of Medicine - Amarillo Recruiting
Amarillo, Texas, United States, 79106
Contact: Curtis W. Turner     806-354-5434X264        
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78207
Contact: Paul Thomas     210-704-2187        
United States, Utah
Primary Children's Medical Center Recruiting
Salt Lake City, Utah, United States, 84113-1100
Contact: Phillip E. Barnette     801-662-4700        
United States, Vermont
Fletcher Allen Health Care - University Health Center Campus Recruiting
Burlington, Vermont, United States, 05401
Contact: Clinical Trials Office - Fletcher Allen Health Care     802-656-8990        
United States, Virginia
Carilion Medical Center for Children at Roanoke Community Hospital Recruiting
Roanoke, Virginia, United States, 24029
Contact: Joan M. Fisher     540-981-7376        
Children's Hospital of The King's Daughters Recruiting
Norfolk, Virginia, United States, 23507-1971
Contact: Eric J. Lowe     757-668-7243        
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042-3300
Contact: Clinical Trials Office - Inova Fairfax Hospital     703-208-6650        
Naval Medical Center - Portsmouth Recruiting
Portsmouth, Virginia, United States, 23708-2197
Contact: Clinical Trials Office - Naval Medical Center - Portsmouth     757-953-5939        
United States, Washington
Children's Hospital and Regional Medical Center - Seattle Recruiting
Seattle, Washington, United States, 98105
Contact: Douglas Hawkins     206-987-3096        
Madigan Army Medical Center - Tacoma Recruiting
Tacoma, Washington, United States, 98431
Contact: Wanda L. Salzer     301-402-6268        
Mary Bridge Children's Hospital and Health Center - Tacoma Recruiting
Tacoma, Washington, United States, 98405
Contact: Ronald Louie     253-403-3481        
Providence Cancer Center at Sacred Heart Medical Center Recruiting
Spokane, Washington, United States, 99220-2555
Contact: Judy Felgenhauer     509-474-2777        
United States, West Virginia
West Virginia University Health Sciences Center - Charleston Recruiting
Charleston, West Virginia, United States, 25302
Contact: Elizabeth Kurczynski     304-388-1540        
United States, Wisconsin
Marshfield Clinic - Marshfield Center Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Clinical Trials Office - Marshfield Clinic - Marshfield Center     800-782-1581 ext. 94457        
Midwest Children's Cancer Center at Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Bruce M. Camitta     414-456-4106        
St. Vincent Hospital Regional Cancer Center Recruiting
Green Bay, Wisconsin, United States, 54307-3508
Contact: Clinical Trials Office - St. Vincent Hospital Regional Cancer     920-433-8889        
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Recruiting
Madison, Wisconsin, United States, 53792-6164
Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo     608-262-5223        
Australia, New South Wales
Prince of Wales Private Hospital Recruiting
Randwick, New South Wales, Australia, 2031
Contact: Draga Barbaric     612-9382-1721        
Westmead Institute for Cancer Research at Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Geoffrey McCowage     61298452122        
Australia, Western Australia
Princess Margaret Hospital for Children Recruiting
Perth, Western Australia, Australia, 6001
Contact: Catherine Cole     011-6189340-8238        
Canada
Centre Hospitalier Universitaire de Quebec Recruiting
Quebec, Canada, G1V 4G2
Contact: Yvan Samson     418-656-4141x47191        
Canada, Alberta
Alberta Children's Hospital Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Douglas R. Strother     403-955-7272        
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Sunil Desai     780-407-8829        
Canada, British Columbia
Children's & Women's Hospital of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Mason Bond     604-875-2322        
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Rochelle Yanofsky     204-787-4163        
Canada, Newfoundland and Labrador
Janeway Children's Health and Rehabilitation Centre Recruiting
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Contact: John (Jack) P. Hand     709-777-4799        
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Margaret C. Yhap     902-470-8778        
Canada, Ontario
Cancer Centre of Southeastern Ontario at Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 3N6
Contact: Mariana P. Silva     16135496666x3833        
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Jacqueline Halton     613-737-7600x2370        
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Ronald M. Grant     416-813-8885        
McMaster Children's Hospital at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Carol A. Portwine     905-521-2100x73464        
Canada, Quebec
Hopital Sainte Justine Recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Albert Moghrabi     514-345-4969        
Montreal Children's Hospital at McGill University Health Center Recruiting
Montreal, Quebec, Canada, H3H 1P3
Contact: Sharon Abish     514-412-4400x22219        
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital Recruiting
Regina, Saskatchewan, Canada, S4T 7T1
Contact: Mansoor M. Haq     306-766-2498        
Saskatoon Cancer Centre at the University of Saskatchewan Recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
Contact: Kaiser Ali     306-655-2744        
New Zealand
Starship Children's Health Recruiting
Auckland, New Zealand, 1
Contact: Lochie Teague     64930749496368        
Puerto Rico
San Jorge Children's Hospital Recruiting
Santurce, Puerto Rico, 00912
Contact: Luis A. Clavell     787-728-1575        
Switzerland
Swiss Pediatric Oncology Group Bern Recruiting
Bern, Switzerland, 3010
Contact: Roland A. Ammann     41316329495        
Swiss Pediatric Oncology Group Geneva Recruiting
Geneva, Switzerland, 1205
Contact: Hulya A. Ozsahin     0041223824712        
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: A. Lindsay Frazier, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Children's Oncology Group - Group Chair Office ( Gregory H. Reaman )
Study ID Numbers: CDR0000269433, COG-AGCT0132
Study First Received: January 27, 2003
Last Updated: November 7, 2009
ClinicalTrials.gov Identifier: NCT00053352     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
childhood malignant ovarian germ cell tumor
childhood extragonadal germ cell tumor
childhood malignant testicular germ cell tumor
childhood extracranial germ cell tumor
childhood teratoma

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Gonadal Disorders
Physiological Effects of Drugs
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Antibiotics, Antineoplastic
Bleomycin
Pharmacologic Actions
 Adnexal Diseases
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Cisplatin
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Antineoplastic Agents, Phytogenic
Etoposide
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 22, 2009



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