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A Phase III Study Of Reduced Therapy In The Treatment Of Children With Low And Intermediate Risk Extracranial Germ Cell Tumors


Phase 3
N/A
21 Years
Open (Enrolling)
Both
Childhood Embryonal Tumor, Childhood Extracranial Germ Cell Tumor, Childhood Extragonadal Germ Cell Tumor, Childhood Malignant Ovarian Germ Cell Tumor, Childhood Malignant Testicular Germ Cell Tumor, Childhood Teratoma, Ovarian Embryonal Carcinoma, Ovarian Yolk Sac Tumor, Stage II Malignant Testicular Germ Cell Tumor, Stage IIA Ovarian Germ Cell Tumor, Stage IIB Ovarian Germ Cell Tumor, Stage IIC Ovarian Germ Cell Tumor, Stage III Malignant Testicular Germ Cell Tumor, Stage IIIA Ovarian Germ Cell Tumor, Stage IIIB Ovarian Germ Cell Tumor, Stage IIIC Ovarian Germ Cell Tumor, Testicular Choriocarcinoma and Yolk Sac Tumor, Testicular Embryonal Carcinoma

Thank you

Trial Information

A Phase III Study Of Reduced Therapy In The Treatment Of Children With Low And Intermediate Risk Extracranial Germ Cell Tumors


OBJECTIVES:

I. 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 (low-risk disease closed to accrual as of 01/20/10).

II. Determine the percentage of patients with stage I ovarian or stage I testicular GCTs for
whom chemotherapy can be eliminated.

III. Determine the percentage of intermediate-risk patients who require only 3 courses of
therapy.

IV. Determine the acute toxic effects of compressed therapy in these patients. V. Determine
the long-term sequelae in patients treated with this regimen. VI. Determine the number of
hospital days and total drug doses required for patients treated with compressed therapy.

VII. Compare the number of protocol-directed treatment days used in CCG-8882 vs the number
of treatment days used in this study.

VIII. 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. (closed to accrual as of 01/20/2010)

Intermediate-risk disease: After surgery, patients proceed to compressed induction
chemotherapy.

COMPRESSED INDUCTION CHEMOTHERAPY: 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 3 more courses of 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 up monthly for 6 months, every 3 months for 18 months, and then
annually for up to 10 years.


Inclusion Criteria:



- Extracranial germ cell tumor that contains 1 of the following malignant histologies:
NOTE: Mixed germ cell tumors that include mature/immature teratoma are eligible
provided 1 of the 3 histologies listed above is also present in the tumor.

- Yolk sac tumor

- Embryonal carcinoma

- Choriocarcinoma

- Low-risk disease (closed to accrual as of 01/20/10)

- Stage I gonadal tumors (ovarian and testicular)

- Must have undergone complete surgical and radiologic staging to exclude the
possibility of > stage I disease

- Intermediate-risk disease

- Stage II, III, or IV malignant testicular GCT

- Stage II or III malignant ovarian GCT

- Stage I or II malignant extragonadal GCT

- Previously stage I gonadal patients who have relapsed on the low-risk
(observation) stratum of this study(closed to accrual as of 01/20/10)

- Patients with immature teratoma or mature teratoma who relapse with a malignant
component

- No patients with any of the following diagnoses:

- Stage IV ovarian and stage III-IV extragonadal GCT

- Intracranial GCT

- Pure mature or immature teratoma, pure dysgerminoma, or seminoma

- Patients with a non-germ cell component in their GCT (e.g., primitive
neuroectodermal tumors or rhabdomyosarcoma)

- Alpha-fetoprotein and beta human chorionic gonadotropin tumor markers known

- If > 5 days have elapsed from the time of obtaining original markers, tumor
markers must be repeated before enrollment of low-risk patients and before
initiating therapy in intermediate-risk patients (the results of the repeated
tumor markers do not have to be known at the time of study enrollment)

- Must be enrolled within 6 weeks of original diagnostic surgery

- Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR a serum creatinine based on
age/gender as follows:

- ≤ 0.4 mg/dL (for patients 1 to 5 months of age)

- ≤ 0.5 mg/dL (for patients 6 to 11 months of age)

- ≤ 0.6 mg/dL (for patients 1 year of age)

- ≤ 0.8 mg/dL (for patients 2 to 5 years of age)

- ≤ 1.0 mg/dL (for patients 6 to 9 years of age)

- ≤ 1.2 mg/dL (for patients 10 to 12 years of age)

- ≤ 1.4 mg/dL (for female patients ≥ 13 years of age)

- ≤ 1.5 mg/dL (for male patients 13 to 15 years of age)

- ≤ 1.7 mg/dL (for male patients ≥ 16 years of age)

- No prior chemotherapy

- No prior radiotherapy

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event-free survival (EFS) of at least 92% (for intermediate-risk tumors only) defined as the first occurrence of relapse, progressive disease, second malignancy, or death after the start of protocol-specified chemotherapy

Outcome Description:

A piecewise exponential failure rate model for the theoretical EFS time for both the low and intermediate risk patients will be used.

Outcome Time Frame:

Assessed up to 3 years

Safety Issue:

No

Principal Investigator

Anne Frazier

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

AGCT0132

NCT ID:

NCT00053352

Start Date:

November 2003

Completion Date:

Related Keywords:

  • Childhood Embryonal Tumor
  • Childhood Extracranial Germ Cell Tumor
  • Childhood Extragonadal Germ Cell Tumor
  • Childhood Malignant Ovarian Germ Cell Tumor
  • Childhood Malignant Testicular Germ Cell Tumor
  • Childhood Teratoma
  • Ovarian Embryonal Carcinoma
  • Ovarian Yolk Sac Tumor
  • Stage II Malignant Testicular Germ Cell Tumor
  • Stage IIA Ovarian Germ Cell Tumor
  • Stage IIB Ovarian Germ Cell Tumor
  • Stage IIC Ovarian Germ Cell Tumor
  • Stage III Malignant Testicular Germ Cell Tumor
  • Stage IIIA Ovarian Germ Cell Tumor
  • Stage IIIB Ovarian Germ Cell Tumor
  • Stage IIIC Ovarian Germ Cell Tumor
  • Testicular Choriocarcinoma and Yolk Sac Tumor
  • Testicular Embryonal Carcinoma
  • Carcinoma
  • Choriocarcinoma
  • Endodermal Sinus Tumor
  • Carcinoma, Embryonal
  • Neoplasms, Germ Cell and Embryonal
  • Teratoma
  • Testicular Neoplasms
  • Germinoma
  • Ovarian Neoplasms

Name

Location

Baylor College of MedicineHouston, Texas  77030
Roswell Park Cancer InstituteBuffalo, New York  14263
Mayo ClinicRochester, Minnesota  55905
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Washington University School of MedicineSaint Louis, Missouri  63110
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Hurley Medical CenterFlint, Michigan  48503
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Loyola University Medical CenterMaywood, Illinois  60153
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Marshfield ClinicMarshfield, Wisconsin  54449
Loma Linda University Medical CenterLoma Linda, California  92354
Newark Beth Israel Medical CenterNewark, New Jersey  07112
New York Medical CollegeValhalla, New York  10595
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Baystate Medical CenterSpringfield, Massachusetts  01199
Hackensack University Medical CenterHackensack, New Jersey  07601
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's National Medical CenterWashington, District of Columbia  20010-2970
Miami Children's HospitalMiami, Florida  33155-4069
All Children's HospitalSt. Petersburg, Florida  33701
Advocate Hope Children's HospitalOak Lawn, Illinois  60453
Saint Jude Midwest AffiliatePeoria, Illinois  61637
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Legacy Emanuel Hospital and Health CenterPortland, Oregon  97227
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Driscoll Children's HospitalCorpus Christi, Texas  78466
Scott and White Memorial HospitalTemple, Texas  76508
Southern California Permanente Medical GroupDowney, California  90242
Children's Hospital Central CaliforniaMadera, California  93638-8762
Kosair Children's HospitalLouisville, Kentucky  40202-3830
Brooklyn Hospital CenterBrooklyn, New York  11201
Children's Hospital Medical Center of AkronAkron, Ohio  44308
Covenant Children's HospitalLubbock, Texas  79410
University of Wisconsin Hospital and ClinicsMadison, Wisconsin  53792-0001
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Methodist Children's Hospital of South TexasSan Antonio, Texas  78229-3993
Primary Children's Medical CenterSalt Lake City, Utah  84113-1100
Montefiore Medical CenterBronx, New York  10467-2490
Saint Peter's University HospitalNew Brunswick, New Jersey  08901-1780
Rady Children's Hospital - San DiegoSan Diego, California  92123-4282
Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolis, Minnesota  55404
Nationwide Children's HospitalColumbus, Ohio  43205-2696
Children's Hospital of Pittsburgh of UPMCPittsburgh, Pennsylvania  15213
Dell Children's Medical Center of Central TexasAustin, Texas  78723
Children's Hospital and Research Center at OaklandOakland, California  94609-1809
Lee Memorial Health SystemFort Myers, Florida  33902
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Connecticut Children's Medical CenterHartford, Connecticut  06106
Duke University Medical CenterDurham, North Carolina  27710
University of FloridaGainesville, Florida  32610-0277
University of RochesterRochester, New York  14642
Helen DeVos Children's Hospital at Spectrum HealthGrand Rapids, Michigan  49503
Yale UniversityNew Haven, Connecticut  06520
Wayne State UniversityDetroit, Michigan  48202
Mercy Children's HospitalToledo, Ohio  43608
Dartmouth Hitchcock Medical CenterLebanon, New Hampshire  03756
University Of VermontBurlington,, Vermont  05403
Albany Medical CenterAlbany, New York  12208
University of Texas Southwestern Medical CenterDallas, Texas  
University of KentuckyLexington, Kentucky  40536-0098
Oregon Health and Science UniversityPortland, Oregon  97201
Memorial Health University Medical CenterSavannah, Georgia  31404
M D Anderson Cancer CenterHouston, Texas  77030
Seattle Children's HospitalSeattle, Washington  98105
Wake Forest University Health SciencesWinston-Salem, North Carolina  27157
Childrens Memorial HospitalChicago, Illinois  60614
Kaiser Permanente-OaklandOakland, California  94611
Sutter General HospitalSacramento, California  95816
University of HawaiiHonolulu, Hawaii  96813
Saint Luke's Mountain States Tumor InstituteBoise, Idaho  83712
Saint John Hospital and Medical CenterDetroit, Michigan  48236
Michigan State University - Breslin Cancer CenterEast Lansing, Michigan  48824-1313
New York University Langone Medical CenterNew York, New York  10016
Columbia University Medical CenterNew York, New York  10032
State University of New York Upstate Medical UniversitySyracuse, New York  13210
Mission Hospitals IncAsheville, North Carolina  28801
Saint Vincent HospitalGreen Bay, Wisconsin  54301
Cook Children's Medical CenterFort Worth, Texas  76104
Memorial Healthcare System - Joe DiMaggio Children's HospitalHollywood, Florida  33021
West Virginia University CharlestonCharleston, West Virginia  25304
The Children's Medical Center of DaytonDayton, Ohio  45404
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, Florida  33136
University of Minnesota Medical Center-FairviewMinneapolis, Minnesota  55455
C S Mott Children's HospitalAnn Arbor, Michigan  48109
Southern Illinois UniversitySpringfield, Illinois  62702
UMDNJ - Robert Wood Johnson University HospitalNew Brunswick, New Jersey  08903
Phoenix Childrens HospitalPhoenix, Arizona  85016
Miller Children's HospitalLong Beach, California  90806
Childrens Hospital of Orange CountyOrange, California  92868-3874
Alfred I duPont Hospital for ChildrenWilmington, Delaware  19803
Children's Healthcare of Atlanta - EglestonAtlanta, Georgia  30322
The Childrens Mercy HospitalKansas City, Missouri  64108
Rainbow Babies and Childrens HospitalCleveland, Ohio  44106
Penn State Hershey Children's HospitalHershey, Pennsylvania  17033
Palmetto Health RichlandColumbia, South Carolina  29203
East Tennessee Childrens HospitalKnoxville, Tennessee  37916
Texas Tech University Health Science Center-AmarilloAmarillo, Texas  79106
Childrens Hospital-King's DaughtersNorfolk, Virginia  23507
Sanford Medical Center-FargoFargo, North Dakota  58122
Children's Hospital ColoradoAurora, Colorado  80045
Lucile Packard Children's Hospital Stanford UniversityPalo Alto, California  94304
University of California San Francisco Medical Center-ParnassusSan Francisco, California  94143
Saint Christopher's Hospital for ChildrenPhiladelphia, Pennsylvania  19134
T C Thompson Children's HospitalChattanooga, Tennessee  37403
Carilion Clinic Children's HospitalRoanoke, Virginia  24014
Broward Health Medical CenterFort Lauderdale, Florida  33316
The Steven and Alexandra Cohen Children's Medical Center of New YorkNew Hyde Park, New York  11040