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RANDOMIZED MULTIINSTITUTIONAL PHASE III TRIAL OF BEP AND HIGH DOSE CHEMOTHERAPY VERSUS BEP ALONE IN PREVIOUSLY UNTREATED PATIENTS WITH POOR RISK GERM CELL TUMORS


Phase 3
12 Years
N/A
Not Enrolling
Male
Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Testicular Germ Cell Tumor

Thank you

Trial Information

RANDOMIZED MULTIINSTITUTIONAL PHASE III TRIAL OF BEP AND HIGH DOSE CHEMOTHERAPY VERSUS BEP ALONE IN PREVIOUSLY UNTREATED PATIENTS WITH POOR RISK GERM CELL TUMORS


OBJECTIVES:

- Compare the efficacy of bleomycin, etoposide, and cisplatin (BEP) with or without
high-dose carboplatin, etoposide, and cyclophosphamide plus autologous bone marrow or
peripheral blood stem cell transplantation in male patients with poor- or
intermediate-risk germ cell tumors.

- Compare the toxicity of these regimens in these patients.

- Compare prospectively the prognosis in terms of the rate of decline of the serum tumor
markers, human chorionic gonadotropin (hCG) and alpha-fetoprotein (AFP), in patients
treated with these regimens.

- Correlate hCG and AFP with complete response and survival in patients treated with
these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center and risk status (poor vs intermediate). Patients are randomized to 1 of
2 treatment arms.

- Arm I: Patients receive bleomycin IV on days 1, 8, and 15 and etoposide (VP-16) IV over
30-60 minutes and cisplatin (CDDP) IV over 30-60 minutes on days 1-5 (BEP). Filgrastim
(G-CSF) is administered subcutaneously (SC) on days 7-16 or until blood counts recover.
Treatment continues every 3 weeks for 4 courses in the absence of disease progression
or unacceptable toxicity. G-CSF is discontinued 24 hours before initiating subsequent
courses of chemotherapy, and withheld on days of bleomycin administration.

- Arm II: Patients receive 2 courses of BEP and G-CSF as in arm I. Patients who have no
marrow involvement with tumor undergo harvest of autologous bone marrow before the
first or second course of BEP. Patients who have bone marrow involvement with tumor
undergo harvest of G-CSF-mobilized autologous peripheral blood stem cells (PBSC) on
days 17-21 of the first and/or second courses of BEP. When blood counts recover,
patients receive high-dose intensification comprising carboplatin IV over 1 hour, VP-16
IV over 30-60 minutes, and cyclophosphamide IV over 1 hour on days -5 to -3. Autologous
bone marrow or PBSC are reinfused over 15-20 minutes on day 0. G-CSF is administered SC
beginning 24 hours after transplantation and continuing until blood counts recover.
Beginning 1-3 weeks after hospital discharge for the first transplantation and after
recovery from any toxic effects, patients with a Karnofsky performance status of
70-100% receive a second course of high-dose intensification plus a second bone marrow
or PBSC transplantation in the absence of disease progression or unacceptable toxicity.

Patients on both arms with brain metastases at presentation undergo radiotherapy and/or
surgery concurrently with BEP, if medically indicated.

Patients with normal alpha fetoprotein (AFP) and human chorionic gonadotropin (hCG) tumor
marker levels after completion of treatment on arm I or II undergo surgical resection of all
residual masses. Patients who have no residual malignant tumor or undergo complete resection
of only a mature teratoma receive no further therapy. Patients on arm I who undergo complete
resection of residual malignant tumor receive 2 additional courses of VP-16 and CDDP without
bleomycin. Patients on arm II who undergo complete resection of residual malignant tumor
receive no additional chemotherapy. Patients with an unresectable residual malignant tumor
receive additional therapy at the discretion of the treating physician. Patients with
residual tumor marker (AFP and hCG) positivity after treatment on arm I or II undergo
resection of residual masses if tumor marker values fall to normal by marker half-life.

PROJECTED ACCRUAL: A total of 270 patients (135 per treatment arm) will be accrued for this
study within 4.4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven poor-risk, nonseminoma germ cell tumor

- Must meet 1 of the following 3 conditions:

- Testis or retroperitoneal primary site without visceral metastasis but with
any of the following tumor marker values:

- Lactic dehydrogenase (LDH) greater than 10 times upper limit of normal
(ULN)

- Human chorionic gonadotropin (hCG) greater than 50,000 IU/L

- Alpha-fetoprotein (AFP) greater than 10,000 ng/mL

- Testis or retroperitoneal primary site with 1 or more nonpulmonary visceral
metastases (regardless of tumor marker values), including the following:

- Bone

- Brain

- Liver

- Other nonpulmonary viscera (e.g., skin, spleen)

- Mediastinal primary site, regardless of presence/absence of visceral
metastasis or tumor marker values OR

- Histologically proven intermediate-risk, nonseminoma germ cell tumor

- Testis or retroperitoneal primary site with no visceral metastasis (except
lung), and with any of the following tumor marker values:

- LDH 3-10 times ULN

- hCG 5,000-50,000 IU/L

- AFP 1,000-10,000 ng/mL OR

- Histologically proven intermediate-risk, seminoma germ cell tumor with 1 or more
nonpulmonary visceral metastases (regardless of tumor marker values or primary site),
including the following:

- Bone

- Brain

- Liver

- Other nonpulmonary visceral metastasis (e.g., skin, spleen)

- Histologic confirmation may be delayed, at the discretion of the protocol chairman,
until after initiation of study therapy for patients with a testicular mass and
elevated AFP or hCG if medical circumstances warrant immediate treatment

- Measurable or evaluable disease

- Concurrent registration on protocol MSKCC-89076 (SWOG-9345) for tumor biology studies
required

PATIENT CHARACTERISTICS:

Age:

- 12 and over

Sex:

- Male

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 3,000/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- See Disease Characteristics

Renal:

- Creatinine no greater than ULN* OR

- Creatinine clearance greater than 50 mL/min* NOTE: * Abnormal levels due to ureteral
obstruction by tumor allowed at the discretion of the protocol chairman

Other:

- HIV negative

- No other concurrent malignancy except nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

- No other concurrent chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- At least 30 days since prior radiotherapy except for brain metastases or documented
disease progression

- Recovered from the toxic effects of any prior radiotherapy

Surgery:

- Recovered from the effects of any recent surgery

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Robert J. Motzer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

SWOG-9442

NCT ID:

NCT00002596

Start Date:

September 1994

Completion Date:

July 2006

Related Keywords:

  • Childhood Germ Cell Tumor
  • Extragonadal Germ Cell Tumor
  • Testicular Germ Cell Tumor
  • stage II malignant testicular germ cell tumor
  • stage III malignant testicular germ cell tumor
  • testicular seminoma
  • testicular embryonal carcinoma
  • testicular choriocarcinoma
  • testicular teratoma
  • testicular yolk sac tumor
  • testicular embryonal carcinoma and teratoma
  • testicular embryonal carcinoma and teratoma with seminoma
  • testicular embryonal carcinoma and yolk sac tumor
  • testicular embryonal carcinoma and yolk sac tumor with seminoma
  • testicular embryonal carcinoma and seminoma
  • testicular yolk sac tumor and teratoma
  • testicular yolk sac tumor and teratoma with seminoma
  • testicular choriocarcinoma and yolk sac tumor
  • testicular choriocarcinoma and embryonal carcinoma
  • testicular choriocarcinoma and teratoma
  • testicular choriocarcinoma and seminoma
  • extragonadal germ cell tumor
  • childhood teratoma
  • childhood malignant testicular germ cell tumor
  • childhood extragonadal germ cell tumor
  • Neoplasms, Germ Cell and Embryonal

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Chao Family Comprehensive Cancer CenterOrange, California  92868
Stanford University Medical CenterStanford, California  94305-5408
University of Colorado Cancer CenterDenver, Colorado  80262
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
MBCCOP - HawaiiHonolulu, Hawaii  96813
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
CCOP - WichitaWichita, Kansas  67214-3882
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Vermont Cancer CenterBurlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
Veterans Affairs Medical Center - Indianapolis (Roudebush)Indianapolis, Indiana  46202
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Northern New JerseyHackensack, New Jersey  07601
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Loyola University Medical CenterMaywood, Illinois  60153
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
Morristown Memorial HospitalMorristown, New Jersey  07962-1956
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Lombardi Cancer CenterWashington, District of Columbia  20007
Henry Ford HospitalDetroit, Michigan  48202
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Sutter Health Western Division Cancer Research GroupGreenbrae, California  94904
Tulane University School of MedicineNew Orleans, Louisiana  70112
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
CCOP - DaytonKettering, Ohio  45429
Harrington Cancer CenterAmarillo, Texas  79106
Green Mountain Oncology GroupRutland, Vermont  05701
Veterans Affairs Medical Center - White River JunctionWhite River Junction, Vermont  05009
Martha Jefferson HospitalCharlottesville, Virginia  22901
Veterans Affairs Medical Center - MadisonMadison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Veterans Affairs Medical Center - Lakeside ChicagoChicago, Illinois  60611
CCOP - Marshfield Medical Research and Education FoundationMarshfield, Wisconsin  54449
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
North Shore University HospitalManhasset, New York  11030
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
University of Kansas Medical CenterKansas City, Kansas  66160-7353
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Boston Medical CenterBoston, Massachusetts  02118
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Texas Tech University Health Science CenterLubbock, Texas  79415
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
CCOP - NorthwestTacoma, Washington  98405-0986
Puget Sound Oncology ConsortiumSeattle, Washington  98109
Sutter Cancer CenterSacramento, California  95816
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
Holden Comprehensive Cancer CenterIowa City, Iowa  52242-1009
Baptist Hospital East - LouisvilleLouisville, Kentucky  40207
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - FargoFargo, North Dakota  58102
CCOP - OklahomaTulsa, Oklahoma  74136
Oncology and Hematology Associates of Southwest Virginia, Inc.Roanoke, Virginia  24014
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Hackensack University Medical CenterHackensack, New Jersey  07601
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
University of California Davis Cancer CenterSacramento, California  95817
Broward General Medical CenterFort Lauderdale, Florida  33316
Florida Hospital Cancer InstituteOrlando, Florida  32804
Marlene and Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201-1595
University of Massachusetts Memorial Medical Center - University CampusWorcester, Massachusetts  01655
James P. Wilmot Cancer CenterRochester, New York  14642
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Northeast Alabama Regional Medical CenterAnniston, Alabama  36207
City of Hope Comprehensive Cancer CenterDuarte, California  91010
St. Joseph Hospital - OrangeOrange, California  92868
Veterans Affairs Medical Center - San DiegoSan Diego, California  92161
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
John Muir Medical CenterWalnut Creek, California  94598
Veterans Affairs Medical Center - Washington, DCWashington, District of Columbia  20422
Memorial Regional Hospital Comprehensive Cancer CenterHollywood, Florida  33021
Helen and Harry Gray Cancer Institute at Good Samaritan Medical CenterWest Palm Beach, Florida  33401
Mountain States Tumor InstituteBoise, Idaho  83712
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
West Suburban Center for Cancer CareRiver Forest, Illinois  60305
Saint Anthony Medical CenterRockford, Illinois  61108
Fort Wayne Medical Oncology and Hematology, IncorporatedFort Wayne, Indiana  46885-5099
Iowa Methodist Medical CenterDes Moines, Iowa  50309
Mercy Medical CenterDes Moines, Iowa  50314
Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Veterans Affairs Medical Center - BaltimoreBaltimore, Maryland  21201
Tuft-New England Medical CenterBoston, Massachusetts  02111
Lakeland Medical Center - St. JosephSaint Joseph, Michigan  49085
Alegent Health-Midlands Community HospitalPapillion, Nebraska  68128-4157
Veterans Affairs Medical Center - Las VegasLas Vegas, Nevada  89106
Cooper University HospitalCamden, New Jersey  08103
Albert Einstein Clinical Cancer CenterBronx, New York  10461
Elmhurst Hospital CenterElmhurst, New York  11373
Queens Cancer Center of Queens HospitalJamaica, New York  11432
Weill Medical College of Cornell UniversityNew York, New York  10021
Veterans Affairs Medical Center - AshevilleAsheville, North Carolina  28805
NorthEast Oncology AssociatesConcord, North Carolina  28025
Cape Fear Valley Health SystemFayetteville, North Carolina  28302-2000
Lenoir Memorial Hospital Cancer CenterKinston, North Carolina  28503-1678
FirstHealth Moore Regional HospitalPinehurst, North Carolina  28374
New Hanover Regional Medical CenterWilmington, North Carolina  28402-9025
Oregon Cancer InstitutePortland, Oregon  97201-3098
Lifespan: The Miriam HospitalProvidence, Rhode Island  02906
Danville Radiation Therapy CenterMemphis, Tennessee  38104
University of Tennessee Cancer InstituteMemphis, Tennessee  38103
Veterans Affairs Medical Center - AmarilloAmarillo, Texas  79106
Veterans Affairs Medical Center - DallasDallas, Texas  75216
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Virginia Oncology Associates - NorfolkNorfolk, Virginia  23502
St. Mary's Medical CenterHuntington, West Virginia  25701
Ministry Medical Group - Northern RegionRhinelander, Wisconsin  54501