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Treatment of Recurrent or Resistant Pediatric Malignant Germ Cell Tumors With Paclitaxel, Ifosfamide and Carboplatin


Phase 2
N/A
21 Years
Open (Enrolling)
Both
Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Ovarian Cancer, Testicular Germ Cell Tumor

Thank you

Trial Information

Treatment of Recurrent or Resistant Pediatric Malignant Germ Cell Tumors With Paclitaxel, Ifosfamide and Carboplatin


OBJECTIVES:

Primary

- Determine the response rate in pediatric patients with recurrent or resistant malignant
germ cell tumors treated with paclitaxel, ifosfamide, and carboplatin.

Secondary

- Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and
ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim
(G-CSF) subcutaneously or IV once daily until blood counts return to normal. Treatment
repeats every 21 days for 2 courses in the absence of disease progression or unacceptable
toxicity.

After completion of study treatment, patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed (at original diagnosis) extracranial germ cell tumor (GCT)
containing 1 of the following malignant elements:

- Yolk sac tumor (endodermal sinus tumor)

- Choriocarcinoma

- Embryonal carcinoma

- Meets 1 of the following disease criteria:

- Recurrent malignant disease

- Chemotherapy-resistant disease

- Relapsed disease

- Disease refractory to conventional therapy

- Measurable disease

- Must have received a prior first-line chemotherapy regimen that included cisplatin

- Patients with tumor marker (AFP and/or BHCG) elevation alone or bone scan findings
alone are not eligible*

- Patients with immature teratoma (any grade), germinoma, sex-cord stromal tumors, or
recurrent GCT previously treated with surgery alone are not eligible NOTE: *Patients
with measurable disease by imaging and elevated tumor markers do not require repeat
biopsy for confirmation of recurrent disease; patients with imaging findings only
(i.e., without concurrent elevation of tumor markers) require histologic confirmation
of recurrence.

PATIENT CHARACTERISTICS:

- Karnofsky performance status (PS) 50-100% (age > 16 years) OR Lansky PS 50-100% (age
≤ 16 years) OR ECOG PS 0-2

- Life expectancy ≥ 8 weeks

- Absolute neutrophil count ≥ 750/mm³

- Platelet count ≥ 75,000/mm³ (transfusion independent)

- Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR
creatinine normal based on age/gender, as defined by the following:

- ≤ 0.4 mg/dL (1 month to < 6 months of age)

- ≤ 0.5 mg/dL (6 months to < 1 year of age)

- ≤ 0.6 mg/dL (1 to < 2 years of age)

- ≤ 0.8 mg/dL (2 to < 6 years of age)

- ≤ 1.0 mg/dL (6 to < 10 years of age)

- ≤ 1.2 mg/dL (10 to < 13 years of age)

- ≤ 1.4 mg/dL (13 to ≥ 16 years of age) (female)

- ≤ 1.5 mg/dL (13 to < 16 years of age) (male)

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

- Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age

- ALT < 2.5 times ULN for age

- Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by gated
radionuclide study

- No dyspnea at rest

- No exercise intolerance

- Pulse oximetry > 94% (if there is clinical indication for determination)

- Patients with seizure disorder are eligible provided they are on non-enzyme inducing
anticonvulsants and seizures are well controlled

- No CNS toxicity > grade 2

- No active graft-versus-host disease

- No allergy to Cremophor EL or castor oil

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Recovered from prior chemotherapy, immunotherapy, or radiotherapy

- At least 1 week since prior growth factors (2 weeks for pegfilgrastim)

- At least 1 week since prior biologic therapy

- At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosourea)

- At least 2 weeks since prior local palliative radiotherapy (i.e., small port)

- At least 6 months since prior craniospinal radiotherapy or radiotherapy to ≥ 50% of
pelvis

- At least 6 weeks since other prior substantial bone marrow radiotherapy

- At least 6 months since prior allogeneic stem cell transplantation

- Concurrent radiotherapy to localized painful lesions allowed provided at least 1
measurable lesion is not irradiated

- No other concurrent chemotherapy or immunomodulating agents

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response as measured by RECIST criteria

Safety Issue:

No

Principal Investigator

Carlos Rodriguez-Galindo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000542424

NCT ID:

NCT00467051

Start Date:

November 2007

Completion Date:

Related Keywords:

  • Childhood Germ Cell Tumor
  • Extragonadal Germ Cell Tumor
  • Ovarian Cancer
  • Testicular Germ Cell Tumor
  • recurrent childhood malignant germ cell tumor
  • childhood extragonadal germ cell tumor
  • childhood malignant ovarian germ cell tumor
  • childhood malignant testicular germ cell tumor
  • ovarian choriocarcinoma
  • ovarian embryonal carcinoma
  • recurrent ovarian germ cell tumor
  • testicular choriocarcinoma and embryonal carcinoma
  • testicular choriocarcinoma and yolk sac tumor
  • testicular choriocarcinoma
  • testicular embryonal carcinoma and yolk sac tumor
  • testicular embryonal carcinoma
  • testicular yolk sac tumor
  • recurrent malignant testicular germ cell tumor
  • ovarian yolk sac tumor
  • childhood extracranial germ cell tumor
  • Ovarian Neoplasms
  • Neoplasms, Germ Cell and Embryonal

Name

Location

Medical City Dallas HospitalDallas, Texas  75230
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
CCOP - MeritCare HospitalFargo, North Dakota  58122
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
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
Nemours Children's ClinicJacksonville, Florida  32207
All Children's HospitalSt. Petersburg, Florida  33701
Children's Memorial Hospital - ChicagoChicago, Illinois  60614
Saint Jude Midwest AffiliatePeoria, Illinois  61637
Children's Hospital of New OrleansNew Orleans, Louisiana  70118
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
Southern California Permanente Medical GroupDowney, California  90242
Kosair Children's HospitalLouisville, Kentucky  40202-3830
Palmetto Health South Carolina Cancer CenterColumbia, South Carolina  29203
East Tennessee Children's HospitalKnoxville, Tennessee  37901
Covenant Children's HospitalLubbock, Texas  79410
Children's Hospital of the King's DaughtersNorfolk, Virginia  23507
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Overlook HospitalSummit, New Jersey  07902-0220
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
Nemours Children's Clinic - OrlandoOrlando, Florida  32806
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida  32803-1273
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
Alvin and Lois Lapidus Cancer Institute at Sinai HospitalBaltimore, Maryland  21215
Hackensack University Medical Center Cancer CenterHackensack, New Jersey  07601
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
Stony Brook University Cancer CenterStony Brook, New York  11794-8174
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Rainbow Babies and Children's HospitalCleveland, Ohio  44106-5000
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Baylor University Medical Center - HoustonHouston, Texas  77030-2399
Methodist Children's Hospital of South TexasSan Antonio, Texas  78229-3993
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical CenterLos Angeles, California  90048-1865
Childrens Hospital Los AngelesLos Angeles, California  90027
Lucile Packard Children's Hospital at Stanford University Medical CenterPalo Alto, California  95798
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Children's Hospital Center for Cancer and Blood DisordersAurora, Colorado  80045
Alfred I. duPont Hospital for ChildrenWilmington, Delaware  19803
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston CampusAtlanta, Georgia  30322
Mountain States Tumor Institute at St. Luke's Regional Medical CenterBoise, Idaho  83712-6297
University of Illinois Cancer CenterChicago, Illinois  60612-7243
Keyser Family Cancer Center at Advocate Hope Children's HospitalOak Lawn, Illinois  60453
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
Tulane Cancer Center Office of Clinical ResearchAlexandria, Louisiana  71315-3198
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolis, Minnesota  55404
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
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
Albany Medical Center HospitalAlbany, New York  12208-3419
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
Dayton Children's - DaytonDayton, Ohio  45404-1815
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Penn State Children's HospitalHershey, Pennsylvania  17033-0850
Children's Hospital of Pittsburgh of UPMCPittsburgh, Pennsylvania  15213
Carilion Medical Center for Children at Roanoke Community HospitalRoanoke, Virginia  24014
West Virginia University Health Sciences Center - CharlestonCharleston, West Virginia  25302
Massachusetts General HospitalBoston, Massachusetts  02114-2617
University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida  33136
Connecticut Children's Medical CenterHartford, Connecticut  06106
Nemours Children's Clinic - PensacolaPensacola, Florida  32504
Helen DeVos Children's Hospital at Spectrum HealthGrand Rapids, Michigan  49503