Neoadjuvant Chemotherapy With or Without Second-Look Surgery Followed by Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Intracranial Germ Cell Tumors
- Conditions
- Interventions
- Registration Number
- NCT00047320
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
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...
- Detailed Description
OBJECTIVES:
* Determine the response rate of patients with non-germinomatous germ cell tumors treated with neoadjuvant chemotherapy.
...
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Radiation Therapy (CR from Induction) peripheral blood stem cell transplantation Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC \> 750/L and platelets \> 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy. Radiation Therapy (CR from Induction) radiation therapy Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC \> 750/L and platelets \> 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy. Radiation Therapy (CR from Induction) neoadjuvant therapy Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC \> 750/L and platelets \> 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy. Radiation Therapy (CR from Induction) adjuvant therapy Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC \> 750/L and platelets \> 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy. Radiation Therapy (CR from Induction) conventional surgery Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC \> 750/L and platelets \> 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy. Radiation Therapy (CR from Induction) carboplatin Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC \> 750/L and platelets \> 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy. Radiation Therapy (CR from Induction) etoposide Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC \> 750/L and platelets \> 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy. Radiation Therapy (CR from Induction) ifosfamide Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC \> 750/L and platelets \> 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy. Radiation Therapy (CR from Induction) thiotepa Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC \> 750/L and platelets \> 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy.
- Primary Outcome Measures
Name Time Method Response to Induction Chemotherapy 18 weeks 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.
- Secondary Outcome Measures
Name Time Method Number of Patients Experiencing Toxic Death During chemotherapy (up to 18 weeks) Toxic death, defined as death predominantly attributable to treatment-related causes.
The Probability of Event-free Survival (EFS) At 3 years from study entry 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.
Progression-free Survival (PFS) At 3 years from study entry 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.
Overall Survival (OS) At 3 years from study entry Overall Survival was defined as time from study entry to death from any cause. Overall survival was estimated by KM estimate.
Occurrence of Non-hematological Grade 4 Toxicity Occurrence of Nonhematological Grade 4 Toxicity During chemotherapy(up to 18 weeks) The number of patients who experienced non-hematological grade 4 toxicities anytime during chemotherapy.
Trial Locations
- Locations (105)
Childrens Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States
Royal Children's Hospital
🇦🇺Parkville, Victoria, Australia
Stanford Cancer Center
🇺🇸Stanford, California, United States
Children's Hospital Central California
🇺🇸Madera, California, United States
Advocate Lutheran General Cancer Care Center
🇺🇸Park Ridge, Illinois, United States
Kaplan Cancer Center at St. Mary's Medical Center
🇺🇸West Palm Beach, Florida, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Children's Hospital and Research Center Oakland
🇺🇸Oakland, California, United States
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
Sacred Heart Cancer Center at Sacred Heart Hospital
🇺🇸Pensacola, Florida, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
Lee Cancer Care of Lee Memorial Health System
🇺🇸Fort Myers, Florida, United States
NYU Cancer Institute at New York University Medical Center
🇺🇸New York, New York, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Akron Children's Hospital
🇺🇸Akron, Ohio, United States
Simmons Cooper Cancer Institute
🇺🇸Springfield, Illinois, United States
Alfred I. duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
All Children's Hospital
🇺🇸Saint Petersburg, Florida, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Hackensack University Medical Center Cancer Center
🇺🇸Hackensack, New Jersey, United States
Breslin Cancer Center at Ingham Regional Medical Center
🇺🇸Lansing, Michigan, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Covenant Children's Hospital
🇺🇸Lubbock, Texas, United States
Driscoll Children's Hospital
🇺🇸Corpus Christi, Texas, United States
St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Marshfield Clinic - Marshfield Center
🇺🇸Marshfield, Wisconsin, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Children's & Women's Hospital of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Rhode Island Hospital Comprehensive Cancer Center
🇺🇸Providence, Rhode Island, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
🇺🇸New York, New York, United States
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Cook Children's Medical Center - Fort Worth
🇺🇸Fort Worth, Texas, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Children's Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, 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
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Methodist Children's Hospital of South Texas
🇺🇸San Antonio, Texas, United States
Rady Children's Hospital - San Diego
🇺🇸San Diego, California, United States
University of Miami Sylvester Comprehensive Cancer Center - Miami
🇺🇸Miami, Florida, United States
Miami Children's Hospital
🇺🇸Miami, Florida, United States
Indiana University Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
St. Vincent Indianapolis Hospital
🇺🇸Indianapolis, Indiana, United States
Floating Hospital for Children at Tufts - New England Medical Center
🇺🇸Boston, Massachusetts, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Primary Children's Medical Center
🇺🇸Salt Lake City, Utah, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
New York Medical College
🇺🇸Valhalla, New York, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
🇺🇸Birmingham, Alabama, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Oregon Health and Science University Cancer Institute
🇺🇸Portland, Oregon, United States
Starship Children's Health
🇳🇿Auckland, New Zealand
Saskatoon Cancer Centre at the University of Saskatchewan
🇨🇦Saskatoon, Saskatchewan, Canada
Swiss Pediatric Oncology Group Bern
🇨🇭Bern, Switzerland
Swiss Pediatric Oncology Group Geneva
🇨🇭Geneva, Switzerland
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Centre Hospitalier Universitaire de Quebec
🇨🇦Quebec, Canada
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
🇺🇸Long Beach, California, United States
Southern California Permanente Medical Group
🇺🇸Downey, California, United States
MBCCOP - Medical College of Georgia Cancer Center
🇺🇸Augusta, Georgia, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Butterworth Hospital at Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
University of Mississippi Cancer Clinic
🇺🇸Jackson, Mississippi, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
🇺🇸Saint Louis, Missouri, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
University of New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
St. Joseph's Hospital and Medical Center
🇺🇸Paterson, New Jersey, United States
Oklahoma University Cancer Institute
🇺🇸Oklahoma City, Oklahoma, United States
St. Christopher's Hospital for Children
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital of The King's Daughters
🇺🇸Norfolk, Virginia, United States
Princess Margaret Hospital for Children
🇦🇺Perth, Western Australia, Australia
Janeway Children's Health and Rehabilitation Centre
🇨🇦St. John's, Newfoundland and Labrador, Canada
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
McMaster Children's Hospital at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Montreal Children's Hospital at McGill University Health Center
🇨🇦Montreal, Quebec, Canada
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
St. Joseph's Cancer Institute at St. Joseph's Hospital
🇺🇸Tampa, Florida, United States
Sanford Cancer Center at Sanford USD Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
West Virginia University Health Sciences Center - Charleston
🇺🇸Charleston, West Virginia, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Sutter Cancer Center
🇺🇸Sacramento, California, United States
University of Florida Shands Cancer Center
🇺🇸Gainesville, Florida, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
🇺🇸Orlando, Florida, 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
Dell Children's Medical Center of Central Texas
🇺🇸Austin, Texas, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States