Recurrent Ovarian Germ Cell Tumor Clinical Trial
Official title:
Treatment of Recurrent or Resistant Pediatric Malignant Germ Cell Tumors With Paclitaxel, Ifosfamide and Carboplatin
Verified date | October 2017 |
Source | Children's Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Children's Oncology Group | National Cancer Institute (NCI) |
United States, Australia, Canada, Puerto Rico,
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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