Brain Tumor Clinical Trial
Official title:
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
Verified date | January 2018 |
Source | Children's Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from
dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink
the tumor so that it is no longer present by conventional imaging and tumor markers from
serum and cerebrospinal fluid. Radiation therapy uses high-energy x-rays to damage tumor
cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of
chemotherapy drugs and kill more tumor cells. Combining different types of therapy may kill
more tumor cells.
PURPOSE: This Phase II trial is studying how well neoadjuvant chemotherapy with or without
surgery and with or without high dose chemotherapy and peripheral stem cell transplantation,
can increase response rates prior to radiation therapy and increase progression free and
overall surviving patients with newly diagnosed intracranial germ cell tumors.
Status | Completed |
Enrollment | 104 |
Est. completion date | February 2009 |
Est. primary completion date | February 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 24 Years |
Eligibility |
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 mIU/mL or any serum/CSF alpha-fetoprotein (AFP) levels greater than 10 ng/ml or above institutional norm - Histologically unconfirmed pineal and/or suprasellar tumors with serum/CSF beta HCG levels greater than 50 mIU/mL or AFP levels greater than 10 ng/ml or above institutional norm - Patients with normal AFP and beta HCG < 50 mIU/mL 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Children's Hospital | Brisbane | Queensland |
Australia | Royal Children's Hospital | Parkville | Victoria |
Australia | Princess Margaret Hospital for Children | Perth | Western Australia |
Canada | IWK Health Centre | Halifax | Nova Scotia |
Canada | McMaster Children's Hospital at Hamilton Health Sciences | Hamilton | Ontario |
Canada | Hopital Sainte Justine | Montreal | Quebec |
Canada | Montreal Children's Hospital at McGill University Health Center | Montreal | Quebec |
Canada | Centre Hospitalier Universitaire de Quebec | Quebec | |
Canada | Saskatoon Cancer Centre at the University of Saskatchewan | Saskatoon | Saskatchewan |
Canada | Janeway Children's Health and Rehabilitation Centre | St. John's | Newfoundland and Labrador |
Canada | Hospital for Sick Children | Toronto | Ontario |
Canada | Children's & Women's Hospital of British Columbia | Vancouver | British Columbia |
New Zealand | Starship Children's Health | Auckland | |
New Zealand | Christchurch Hospital | Christchurch | |
Switzerland | Swiss Pediatric Oncology Group Bern | Bern | |
Switzerland | Swiss Pediatric Oncology Group Geneva | Geneva | |
United States | Akron Children's Hospital | Akron | Ohio |
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
United States | Winship Cancer Institute of Emory University | Atlanta | Georgia |
United States | MBCCOP - Medical College of Georgia Cancer Center | Augusta | Georgia |
United States | Dell Children's Medical Center of Central Texas | Austin | Texas |
United States | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
United States | Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | Birmingham | Alabama |
United States | Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Floating Hospital for Children at Tufts - New England Medical Center | Boston | Massachusetts |
United States | Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx | New York |
United States | Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina |
United States | West Virginia University Health Sciences Center - Charleston | Charleston | West Virginia |
United States | Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina |
United States | Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois |
United States | University of Chicago Cancer Research Center | Chicago | Illinois |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio |
United States | Nationwide Children's Hospital | Columbus | Ohio |
United States | Driscoll Children's Hospital | Corpus Christi | Texas |
United States | Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas |
United States | Children's Medical Center - Dayton | Dayton | Ohio |
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
United States | Southern California Permanente Medical Group | Downey | California |
United States | Duke Comprehensive Cancer Center | Durham | North Carolina |
United States | Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | Farmington | Connecticut |
United States | Lee Cancer Care of Lee Memorial Health System | Fort Myers | Florida |
United States | Cook Children's Medical Center - Fort Worth | Fort Worth | Texas |
United States | University of Florida Shands Cancer Center | Gainesville | Florida |
United States | Butterworth Hospital at Spectrum Health | Grand Rapids | Michigan |
United States | St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin |
United States | Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan |
United States | Hackensack University Medical Center Cancer Center | Hackensack | New Jersey |
United States | Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana |
United States | St. Vincent Indianapolis Hospital | Indianapolis | Indiana |
United States | University of Mississippi Cancer Clinic | Jackson | Mississippi |
United States | Nemours Children's Clinic | Jacksonville | Florida |
United States | Children's Mercy Hospital | Kansas City | Missouri |
United States | Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City | Kansas |
United States | Breslin Cancer Center at Ingham Regional Medical Center | Lansing | Michigan |
United States | Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda | California |
United States | Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | Long Beach | California |
United States | Childrens Hospital Los Angeles | Los Angeles | California |
United States | Covenant Children's Hospital | Lubbock | Texas |
United States | Children's Hospital Central California | Madera | California |
United States | Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin |
United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
United States | Miami Children's Hospital | Miami | Florida |
United States | University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami | Florida |
United States | Midwest Children's Cancer Center | Milwaukee | Wisconsin |
United States | Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota |
United States | Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota |
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
United States | Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick | New Jersey |
United States | Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York | New York |
United States | NYU Cancer Institute at New York University Medical Center | New York | New York |
United States | Newark Beth Israel Medical Center | Newark | New Jersey |
United States | Children's Hospital of The King's Daughters | Norfolk | Virginia |
United States | Children's Hospital and Research Center Oakland | Oakland | California |
United States | Oklahoma University Cancer Institute | Oklahoma City | Oklahoma |
United States | Children's Hospital of Orange County | Orange | California |
United States | Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando | Florida |
United States | Advocate Lutheran General Cancer Care Center | Park Ridge | Illinois |
United States | St. Joseph's Hospital and Medical Center | Paterson | New Jersey |
United States | Sacred Heart Cancer Center at Sacred Heart Hospital | Pensacola | Florida |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | St. Christopher's Hospital for Children | Philadelphia | Pennsylvania |
United States | Phoenix Children's Hospital | Phoenix | Arizona |
United States | Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Oregon Health and Science University Cancer Institute | Portland | Oregon |
United States | Rhode Island Hospital Comprehensive Cancer Center | Providence | Rhode Island |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | Sutter Cancer Center | Sacramento | California |
United States | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Saint Louis | Missouri |
United States | All Children's Hospital | Saint Petersburg | Florida |
United States | Primary Children's Medical Center | Salt Lake City | Utah |
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 | Rady Children's Hospital - San Diego | San Diego | California |
United States | UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California |
United States | Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota |
United States | Simmons Cooper Cancer Institute | Springfield | Illinois |
United States | Stanford Cancer Center | Stanford | California |
United States | SUNY Upstate Medical University Hospital | Syracuse | New York |
United States | St. Joseph's Cancer Institute at St. Joseph's Hospital | Tampa | Florida |
United States | New York Medical College | Valhalla | New York |
United States | Children's National Medical Center | Washington | District of Columbia |
United States | Kaplan Cancer Center at St. Mary's Medical Center | 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, New Zealand, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response to Induction Chemotherapy | A patient who achieves a complete or partial response, defined a reduction of at least 65% in tumor size after induction chemotherapy will be considered to have experienced response. | 18 weeks | |
Secondary | The Probability of Event-free Survival (EFS) | Event-free Survival was defined as time from study entry to death from any cause, disease progression or recurrence, or second malignant neoplasm. Event-free survival was estimated by KM estimate. | At 3 years from study entry | |
Secondary | Progression-free Survival (PFS) | Progression-free Survival was defined as time from study entry to disease progression or recurrence. Deaths that are clearly unrelated to disease progression, and second neoplasms are censored in this analysis. Progression -free survival was estimated by KM estimate. | At 3 years from study entry | |
Secondary | Overall Survival (OS) | Overall Survival was defined as time from study entry to death from any cause. Overall survival was estimated by KM estimate. | At 3 years from study entry | |
Secondary | Number of Patients Experiencing Toxic Death | Toxic death, defined as death predominantly attributable to treatment-related causes. | During chemotherapy (up to 18 weeks) | |
Secondary | Occurrence of Non-hematological Grade 4 Toxicity Occurrence of Nonhematological Grade 4 Toxicity | The number of patients who experienced non-hematological grade 4 toxicities anytime during chemotherapy. | During chemotherapy(up to 18 weeks) |
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