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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00467051
Other study ID # AGCT0521
Secondary ID NCI-2009-00374CO
Status Completed
Phase Phase 2
First received
Last updated
Start date November 5, 2007
Est. completion date June 30, 2018

Study information

Verified date October 2017
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II trial is studying how well giving combination chemotherapy works in treating young patients with recurrent or resistant malignant germ cell tumors. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.


Description:

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

I. Determine the toxicity of this regimen in these patients. II. To Collect tissue for the tumor bank that will aid in the identification of the biological characteristics of recurrent GCT.

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 count returns 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 30, 2018
Est. primary completion date March 1, 2012
Accepts healthy volunteers No
Gender All
Age group N/A to 21 Years
Eligibility Inclusion Criteria:

- 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

- 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

- No other concurrent chemotherapy or immunomodulating agents

- 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

Study Design


Related Conditions & MeSH terms

  • Carcinoma
  • Childhood Extracranial Germ Cell Tumor
  • Childhood Extragonadal Malignant Germ Cell Tumor
  • Childhood Malignant Ovarian Germ Cell Tumor
  • Childhood Malignant Testicular Germ Cell Tumor
  • Choriocarcinoma
  • Germinoma
  • Neoplasms
  • Neoplasms, Germ Cell and Embryonal
  • Ovarian Choriocarcinoma
  • Ovarian Embryonal Carcinoma
  • Ovarian Neoplasms
  • Ovarian Yolk Sac Tumor
  • Recurrent Childhood Malignant Germ Cell Tumor
  • Recurrent Malignant Testicular Germ Cell Tumor
  • Recurrent Ovarian Germ Cell Tumor
  • Testicular Choriocarcinoma
  • Testicular Embryonal Carcinoma
  • Testicular Mixed Choriocarcinoma and Embryonal Carcinoma
  • Testicular Mixed Choriocarcinoma and Yolk Sac Tumor
  • Testicular Mixed Embryonal Carcinoma and Yolk Sac Tumor
  • Testicular Neoplasms
  • Testicular Yolk Sac Tumor

Intervention

Drug:
Carboplatin
Given IV
Biological:
Filgrastim
Given IV or subcutaneously
Drug:
Ifosfamide
Given IV
Other:
Laboratory Biomarker Analysis
Optional correlative studies
Drug:
Paclitaxel
Given IV

Locations

Country Name City State
Australia Princess Margaret Hospital for Children Perth Western Australia
Canada University of Alberta Hospital Edmonton Alberta
Canada IWK Health Centre Halifax Nova Scotia
Canada McMaster Children's Hospital at Hamilton Health Sciences Hamilton Ontario
Canada Centre Hospitalier Universitaire Sainte-Justine Montreal Quebec
Canada Children's Hospital of Eastern Ontario Ottawa Ontario
Canada Centre Hospitalier Universitaire de Quebec Quebec
Canada British Columbia Children's Hospital Vancouver British Columbia
Canada CancerCare Manitoba Winnipeg Manitoba
Puerto Rico San Jorge Children's Hospital San Juan
United States Children's Hospital Medical Center of Akron Akron Ohio
United States Albany Medical Center Albany New York
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Children's Healthcare of Atlanta - Egleston Atlanta Georgia
United States Emory University Hospital/Winship Cancer Institute Atlanta Georgia
United States Children's Hospital Colorado Aurora Colorado
United States Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland
United States Sinai Hospital of Baltimore Baltimore Maryland
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Cancer Center Boston Massachusetts
United States Montefiore Medical Center - Moses Campus Bronx New York
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States West Virginia University Charleston Division Charleston West Virginia
United States Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina
United States Lurie Children's Hospital-Chicago Chicago Illinois
United States University of Illinois Chicago Illinois
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States Rainbow Babies and Childrens Hospital Cleveland Ohio
United States Palmetto Health Richland Columbia South Carolina
United States Nationwide Children's Hospital Columbus Ohio
United States Driscoll Children's Hospital Corpus Christi Texas
United States Medical City Dallas Hospital Dallas Texas
United States Dayton Children's Hospital Dayton Ohio
United States Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver Colorado
United States Kaiser Permanente Downey Medical Center Downey California
United States Sanford Broadway Medical Center Fargo North Dakota
United States University of Connecticut Farmington Connecticut
United States Lee Memorial Health System Fort Myers Florida
United States Cook Children's Medical Center Fort Worth Texas
United States Helen DeVos Children's Hospital at Spectrum Health Grand Rapids Michigan
United States Spectrum Health at Butterworth Campus Grand Rapids Michigan
United States Hackensack University Medical Center Hackensack New Jersey
United States Connecticut Children's Medical Center Hartford Connecticut
United States Penn State Children's Hospital Hershey Pennsylvania
United States Penn State Milton S Hershey Medical Center Hershey Pennsylvania
United States University of Hawaii Cancer Center Honolulu Hawaii
United States Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas
United States Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana
United States Riley Hospital for Children Indianapolis Indiana
United States University of Mississippi Medical Center Jackson Mississippi
United States Nemours Children's Clinic-Jacksonville Jacksonville Florida
United States The Childrens Mercy Hospital Kansas City Missouri
United States East Tennessee Childrens Hospital Knoxville Tennessee
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Miller Children's and Women's Hospital Long Beach Long Beach California
United States Cedars Sinai Medical Center Los Angeles California
United States Children's Hospital Los Angeles Los Angeles California
United States Norton Children's Hospital Louisville Kentucky
United States Covenant Children's Hospital Lubbock Texas
United States St. Jude Children's Research Hospital Memphis Tennessee
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis Minnesota
United States Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick New Jersey
United States Children's Hospital New Orleans New Orleans Louisiana
United States Tulane University Health Sciences Center New Orleans Louisiana
United States Columbia University/Herbert Irving Cancer Center New York New York
United States Children's Hospital of The King's Daughters Norfolk Virginia
United States Advocate Children's Hospital-Oak Lawn Oak Lawn Illinois
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Florida Hospital Orlando Orlando Florida
United States Nemours Children's Clinic - Orlando Orlando Florida
United States Lucile Packard Children's Hospital Stanford University Palo Alto California
United States Saint Joseph's Regional Medical Center Paterson New Jersey
United States Nemours Children's Clinic - Pensacola Pensacola Florida
United States Sacred Heart Hospital Pensacola Florida
United States Saint Jude Midwest Affiliate Peoria Illinois
United States Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania
United States Carilion Clinic Children's Hospital Roanoke Virginia
United States Johns Hopkins All Children's Hospital Saint Petersburg Florida
United States Methodist Children's Hospital of South Texas San Antonio Texas
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States UCSF Medical Center-Mount Zion San Francisco California
United States UCSF Medical Center-Parnassus San Francisco California
United States Overlook Hospital Summit New Jersey
United States State University of New York Upstate Medical University Syracuse New York
United States Saint Joseph's Hospital/Children's Hospital-Tampa Tampa Florida
United States Harbor-University of California at Los Angeles Medical Center Torrance California
United States The University of Arizona Medical Center-University Campus Tucson Arizona
United States Children's National Medical Center Washington District of Columbia
United States MedStar Georgetown University Hospital Washington District of Columbia
United States Saint Mary's Hospital West Palm Beach Florida
United States Alfred I duPont Hospital for Children Wilmington Delaware

Sponsors (2)

Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Response Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Patients who demonstrate a PR or CR, as defined below, will be considered as responders. RECIST criteria: CR (complete response) = disappearance of all target lesions, PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions, PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions and SD (stable disease) = small changes that do not meet above criteria. At baseline (day 1) and after completion of protocol therapy (2 cycles or 42 days)
Secondary The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity. Two cycles of chemotherapy; expected to be 42 days of treatment.
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