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Spots Global Cancer Trial Database for Combination Chemotherapy in Treating Children With Newly Diagnosed Malignant Germ Cell Tumors

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Combination Chemotherapy in Treating Children With Newly Diagnosed Malignant Germ Cell Tumors

Official Title: Pilot Study of Cisplatin, Etoposide, Bleomycin and Escalating Dose Cyclophosphamide Therapy for Children With High Risk Malignant Germ Cell Tumors

Study ID: NCT00066482

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effect on the body of combining cyclophosphamide with cisplatin, etoposide, and bleomycin in treating children who have newly diagnosed malignant germ cell tumors that are not in the brain and gonads.

Detailed Description: OBJECTIVES: * Determine the maximum tolerated dose and toxicity profile of cyclophosphamide in combination with bleomycin, etoposide, and cisplatin in pediatric patients with newly diagnosed high-risk extracranial, extragonadal malignant germ cell tumors. * Determine the response rate in patients treated with this regimen. OUTLINE: This is a pilot, multicenter, dose-escalation study of cyclophosphamide. * Induction therapy: Patients receive bleomycin IV over 10-20 minutes on day 1, etoposide IV over 1 hour and cisplatin IV over 4 hours on days 1-5, and cyclophosphamide IV over 1 hour on day 1. Patients also receive filgrastim (G-CSF) subcutaneously once daily beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 6 patients receive escalating doses of cyclophosphamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are evaluated after 4 courses of therapy. Patients with partial response or stable disease undergo second-look surgery, receive 2 more courses of induction therapy, and are then re-evaluated. Patients who do not achieve complete response (CR) after a total of 6 courses may undergo a third surgery. Patients who still have tumor that cannot be removed are removed from study therapy. Patients who achieve a CR at anytime are followed. Patients are followed monthly for 1 year, every 6 months for 1 year, and then annually for 3 years. PROJECTED ACCRUAL: A total of 6-18 patients will be accrued for this study within 1.3 years.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Comprehensive Cancer Center at University of Alabama at Birmingham, Birmingham, Alabama, United States

Phoenix Children's Hospital, Phoenix, Arizona, United States

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

Southern California Permanente Medical Group, Downey, California, United States

Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda, California, United States

Children's Hospital Los Angeles, Los Angeles, California, United States

Children's Hospital Central California, Madera, California, United States

Children's Hospital of Orange County, Orange, California, United States

Kaiser Permanente Medical Center - Oakland, Sacramento, California, United States

Children's Hospital and Health Center - San Diego, San Diego, California, United States

Stanford Cancer Center at Stanford University Medical Center, Stanford, California, United States

Children's Hospital Cancer Center, Denver, Colorado, United States

Alfred I. duPont Hospital for Children, Wilmington, Delaware, United States

Children's National Medical Center, Washington, District of Columbia, United States

Lee Cancer Care of Lee Memorial Health System, Fort Myers, Florida, United States

University of Florida Shands Cancer Center, Gainesville, Florida, United States

Nemours Children's Clinic, Jacksonville, Florida, United States

University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, United States

Miami Children's Hospital, Miami, Florida, United States

Baptist-South Miami Regional Cancer Program, Miami, Florida, United States

Sacred Heart Cancer Center at Sacred Heart Hospital, Pensacola, Florida, United States

All Children's Hospital, St. Petersburg, Florida, United States

St. Joseph's Cancer Institute at St. Joseph's Hospital, Tampa, Florida, United States

Kaplan Cancer Center at St. Mary's Medical Center, West Palm Beach, Florida, United States

Emory University Hospital - Atlanta, Atlanta, Georgia, United States

Cancer Research Center of Hawaii, Honolulu, Hawaii, United States

Children's Memorial Hospital - Chicago, Chicago, Illinois, United States

Saint Jude Midwest Affiliate, Peoria, Illinois, United States

Southern Illinois University School of Medicine, Springfield, Illinois, United States

St. Vincent Indianapolis Hospital, Indianapolis, Indiana, United States

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, United States

Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky, United States

CancerCare of Maine at Eastern Maine Medial Center, Bangor, Maine, United States

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore, Maryland, United States

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States

C.S. Mott Children's Hospital at University of Michigan, Ann Arbor, Michigan, United States

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States

Hurley Medical Center, Flint, Michigan, United States

Spectrum Health Cancer Care - Butterworth Campus, Grand Rapids, Michigan, United States

Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States

Breslin Cancer Center at Ingham Regional Medical Center, Lansing, Michigan, United States

Children's Hospital of Minnesota - Minneapolis, Minneapolis, Minnesota, United States

Fairview University Medical Center - University Campus, Minneapolis, Minnesota, United States

Mayo Clinic Cancer Center, Rochester, Minnesota, United States

University of Mississippi Medical Center, Jackson, Mississippi, United States

Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, United States

Children's Mercy Hospital, Kansas City, Missouri, United States

Siteman Cancer Center at Barnes-Jewish Hospital, St. Louis, Missouri, United States

Hackensack University Medical Center Cancer Center, Hackensack, New Jersey, United States

St. Barnabas Medical Center, Livingston, New Jersey, United States

Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York, United States

James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States

SUNY Upstate Medical University Hospital, Syracuse, New York, United States

New York Medical College, Valhalla, New York, United States

Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina, United States

Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina, United States

Duke Comprehensive Cancer Center, Durham, North Carolina, United States

Children's Hospital Medical Center of Akron, Akron, Ohio, United States

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

Children's Medical Center - Dayton, Dayton, Ohio, United States

Tod Children's Hospital - Forum Health, Youngstown, Ohio, United States

Oklahoma University Medical Center, Oklahoma City, Oklahoma, United States

Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States

Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States

Greenville Hospital System Cancer Center, Greenville, South Carolina, United States

East Tennessee Children's Hospital, Knoxville, Tennessee, United States

St. Jude Children's Research Hospital, Memphis, Tennessee, United States

Texas Tech University Health Sciences Center School of Medicine, Amarillo, Texas, United States

Children's Hospital of Austin, Austin, Texas, United States

Driscoll Children's Hospital, Corpus Christi, Texas, United States

Medical City Dallas Hospital, Dallas, Texas, United States

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, United States

Cook Children's Medical Center - Fort Worth, Fort Worth, Texas, United States

Baylor University Medical Center - Houston, Houston, Texas, United States

M.D. Anderson Cancer Center at University of Texas, Houston, Texas, United States

Covenant Children's Hospital, Lubbock, Texas, 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

Primary Children's Medical Center, Salt Lake City, Utah, United States

INOVA Fairfax Hospital, Fairfax, Virginia, United States

Carilion Cancer Center of Western Virginia, Roanoke, Virginia, United States

West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division, Charleston, West Virginia, United States

St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States

University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States

Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin, United States

Midwest Children's Cancer Center, Milwaukee, Wisconsin, United States

Princess Margaret Hospital for Children, Perth, Western Australia, Australia

Children's & Women's Hospital of British Columbia, Vancouver, British Columbia, Canada

Janeway Children's Health and Rehabilitation Centre, St. John's, Newfoundland and Labrador, Canada

McMaster Children's Hospital at Hamilton Health Sciences, Hamilton, Ontario, Canada

Hospital for Sick Children, Toronto, Ontario, Canada

Montreal Children's Hospital at McGill University Health Center, Montreal, Quebec, Canada

Hopital Sainte Justine, Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Quebec, Ste-Foy, Quebec, Canada

Allan Blair Cancer Centre at Pasqua Hospital, Regina, Saskatchewan, Canada

San Jorge Children's Hospital, Santurce, , Puerto Rico

Contact Details

Name: Marcio A. Malogolowkin, MD

Affiliation: Children's Hospital Los Angeles

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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