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A Phase II Study To Assess The Ability Of Neoadjuvant Chemotherapy Plus/Minus Second Look Surgery To Eliminate All Measurable Disease Prior To Radiotherapy For NGGCT


Phase 2
3 Years
24 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor

Thank you

Trial Information

A Phase II Study To Assess The Ability Of Neoadjuvant Chemotherapy Plus/Minus Second Look Surgery To Eliminate All Measurable Disease Prior To Radiotherapy For NGGCT


OBJECTIVES:

- Determine the response rate of patients with non-germinomatous germ cell tumors treated
with neoadjuvant chemotherapy.

- Determine the progression-free survival and overall survival of patients treated with
neoadjuvant chemotherapy with or without second-look surgery followed by radiotherapy
with or without autologous peripheral blood stem cell transplantation (PBSCT).

- Determine whether additional complete responses can be achieved after high-dose
thiotepa and etoposide with PBSCT in patients with persistently positive markers,
histological evidence of residual malignant elements, or unresectable residual tumors
after initial neoadjuvant chemotherapy.

- Determine patterns of recurrence in patients treated with this regimen.

- Correlate tumor marker response with radiographic and clinical measures of response, as
well as findings at second-look surgery in patients with radiological evidence of
residual disease.

OUTLINE:

- Induction chemotherapy:

- Courses 1, 3, and 5: Patients receive carboplatin IV over 1 hour on day 1 and
etoposide IV over 1 hour on days 1-3. Beginning on day 4, patients receive
filgrastim (G-CSF) IV or subcutaneously (SC) for 10 days or until blood counts
recover. Courses are 3 weeks in duration.

- Courses 2, 4, and 6: Patients receive etoposide IV over 1 hour followed by
ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive G-CSF
IV or SC for 10 days or until blood counts recover. Courses are 3 weeks in
duration.

Patients undergo re-evaluation. Patients with a complete response (CR) go directly to
radiotherapy. Approximately 3 weeks after completion of induction chemotherapy, all patients
with less than a CR are encouraged to undergo second-look surgery.

After second-look surgery, patients with a CR or a partial response (PR) go directly to
radiotherapy. Patients with less than a PR undergo consolidation chemotherapy with
peripheral blood stem cell rescue (PBSC) followed by radiotherapy.

- Consolidation chemotherapy: Patients undergo PBSC collection. Patients receive G-CSF SC
until PBSC collection is complete. Patients then receive thiotepa IV over 3 hours
followed by etoposide IV over 3 hours on days -5 to -3. PBSCs are reinfused on day 0.
Beginning on day 1 and continuing until blood counts recover, patients receive G-CSF SC
daily.

- Radiotherapy: All patients receive radiotherapy once daily 5 days a week for 5-6 weeks
beginning after recovery from induction chemotherapy or second-look surgery or within 9
weeks after PBSC reinfusion.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months
for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 80-100 patients will be accrued for this study within 36-42
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- One of the following diagnoses:

- Histologically confirmed intracranial non-germinomatous germ cell tumor (NGGCT)
of 1 of the following types:

- Endodermal sinus tumor (yolk sac tumor)

- Embryonal carcinoma

- Choriocarcinoma

- Immature teratoma and teratoma with malignant transformation

- Mixed germ cell tumor

- Histologically confirmed germinoma with elevation of serum/CSF beta human
chorionic gonadotropin (HCG) levels greater than 50 IU/dL or any serum/CSF
alpha-fetoprotein (AFP) levels greater than 10 IU/dL or institutional norm

- Histologically unconfirmed pineal and/or suprasellar tumors with serum/CSF beta
HCG levels greater than 50 IU/dL or AFP levels greater than 10 IU/dL or
institutional norm

- Patients with normal AFP and beta HCG < 50 IU/dL without histologic diagnosis of a
NGGCT or patients with pure germinoma without elevation of tumor marker are
ineligible

- Initial diagnosis within the past 31 days

PATIENT CHARACTERISTICS:

Age

- 3 to 24 at diagnosis

Performance status

- No minimum performance level

Life expectancy

- At least 8 weeks

Hematopoietic

- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 100,000/mm^3 (transfusion independent)

- Hemoglobin at least 10.0 g/dL (transfusion allowed)

Hepatic

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- ALT no greater than 2.5 times ULN

Renal

- Creatinine no greater than 1.5 times ULN OR

- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

Pulmonary

- No assisted ventilation

Other

- Seizure disorders allowed

- No patients in status or coma

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patient must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Prior corticosteroids allowed

- Concurrent corticosteroids allowed

- Concurrent endocrine replacement therapy allowed (e.g., L-thyroxine, testosterone,
estrogen, desmopressin acetate)

- No concurrent growth hormone therapy

Radiotherapy

- Not specified

Surgery

- More than 1 prior surgery allowed

Other

- No other prior therapy for malignancy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response (complete and partial response)

Safety Issue:

No

Principal Investigator

Stewart Goldman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ann & Robert H Lurie Children's Hospital of Chicago

Authority:

United States: Federal Government

Study ID:

CDR0000257664

NCT ID:

NCT00047320

Start Date:

January 2004

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Childhood Germ Cell Tumor
  • childhood central nervous system germ cell tumor
  • childhood teratoma
  • recurrent childhood malignant germ cell tumor
  • childhood central nervous system choriocarcinoma
  • childhood central nervous system embryonal tumor
  • childhood central nervous system germinoma
  • childhood central nervous system mixed germ cell tumor
  • childhood central nervous system teratoma
  • childhood central nervous system yolk sac tumor
  • recurrent childhood central nervous system embryonal tumor
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Neoplasms, Germ Cell and Embryonal

Name

Location

Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Chicago Cancer Research CenterChicago, Illinois  60637
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health CenterFarmington, Connecticut  06360-2875
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Newark Beth Israel Medical CenterNewark, New Jersey  07112
New York Medical CollegeValhalla, New York  10595
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Sutter Cancer CenterSacramento, California  95816
Children's Hospital of Orange CountyOrange, California  92668
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Mercy HospitalKansas City, Missouri  64108
St. Joseph's Hospital and Medical CenterPaterson, New Jersey  07503
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Nemours Children's ClinicJacksonville, Florida  32207
Miami Children's HospitalMiami, Florida  33155-4069
All Children's HospitalSt. Petersburg, Florida  33701
Children's Memorial Hospital - ChicagoChicago, Illinois  60614
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
St. Christopher's Hospital for ChildrenPhiladelphia, Pennsylvania  19134-1095
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Driscoll Children's HospitalCorpus Christi, Texas  78466
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
Southern California Permanente Medical GroupDowney, California  90242
Children's Hospital Central CaliforniaMadera, California  93638-8762
Children's Medical Center - DaytonDayton, Ohio  45404
Covenant Children's HospitalLubbock, Texas  79410
Children's Hospital of the King's DaughtersNorfolk, Virginia  23507
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Loma Linda University Cancer Institute at Loma Linda University Medical CenterLoma Linda, California  92354
Jonathan Jaques Children's Cancer Center at Miller Children's HospitalLong Beach, California  90801
Lee Cancer Care of Lee Memorial Health SystemFort Myers, Florida  33901
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida  32803-1273
Sacred Heart Cancer Center at Sacred Heart HospitalPensacola, Florida  32504
St. Joseph's Cancer Institute at St. Joseph's HospitalTampa, Florida  33607
Kaplan Cancer Center at St. Mary's Medical CenterWest Palm Beach, Florida  33407
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
St. Vincent Indianapolis HospitalIndianapolis, Indiana  46260
Floating Hospital for Children at Tufts - New England Medical CenterBoston, Massachusetts  02111
Breslin Cancer Center at Ingham Regional Medical CenterLansing, Michigan  48910
Hackensack University Medical Center Cancer CenterHackensack, New Jersey  07601
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
NYU Cancer Institute at New York University Medical CenterNew York, New York  10016
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Rhode Island Hospital Comprehensive Cancer CenterProvidence, Rhode Island  02903
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
Methodist Children's Hospital of South TexasSan Antonio, Texas  78229-3993
Primary Children's Medical CenterSalt Lake City, Utah  84113-1100
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Childrens Hospital Los AngelesLos Angeles, California  90027
Children's Hospital and Research Center OaklandOakland, California  94609
Rady Children's Hospital - San DiegoSan Diego, California  92123-4282
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Alfred I. duPont Hospital for ChildrenWilmington, Delaware  19803
MBCCOP - Medical College of Georgia Cancer CenterAugusta, Georgia  30912-3730
Advocate Lutheran General Cancer Care CenterPark Ridge, Illinois  60068-1174
Simmons Cooper Cancer InstituteSpringfield, Illinois  62794-9677
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455
Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolis, Minnesota  55404
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Herbert Irving Comprehensive Cancer Center at Columbia University Medical CenterNew York, New York  10032
Akron Children's HospitalAkron, Ohio  44308-1062
Nationwide Children's HospitalColumbus, Ohio  43205-2696
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Dell Children's Medical Center of Central TexasAustin, Texas  78723
West Virginia University Health Sciences Center - CharlestonCharleston, West Virginia  25302
Stanford Cancer CenterStanford, California  94305-5824
University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida  33136
Lurleen Wallace Comprehensive Cancer at University of Alabama - BirminghamBirmingham, Alabama  35294
Oregon Health and Science University Cancer InstitutePortland, Oregon  97239-3098