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Combination Chemotherapy Plus Amifostine in Treating Children With Malignant Germ Cell Tumors

Information source: Children's Oncology Group
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Childhood Germ Cell Tumor; Drug/Agent Toxicity by Tissue/Organ; Extragonadal Germ Cell Tumor; Ovarian Cancer

Intervention: bleomycin sulfate (Biological); amifostine trihydrate (Drug); cisplatin (Drug); etoposide (Drug); conventional surgery (Procedure)

Phase: Phase 2

Status: Completed

Sponsored by: Children's Oncology Group

Official(s) and/or principal investigator(s):
Neyssa M. Marina, MD, Study Chair, Affiliation: Stanford University

Summary

RATIONALE: Chemotherapy drugs use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase I trial to study the effectiveness of high-dose cisplatin, etoposide, and bleomycin plus amifostine in treating children who have malignant germ cell tumors.

Clinical Details

Official title: High-Dose Cisplatin, Etoposide and Bleomycin (HD-PEB) Combined With Amifostine in Children With High-Risk Malignant Germ Cell Tumors - A POG Pilot Study

Study design: Primary Purpose: Treatment

Primary outcome: Feasibility from Efficacy Standpoint

Secondary outcome: Assessment of Reduction in Toxicity

Detailed description: OBJECTIVES: I. Evaluate the early efficacy and toxicity profile of high-dose cisplatin, etoposide, bleomycin, and amifostine in children with newly diagnosed, high-risk malignant, extragonadal germ cell tumors. II. Determine whether the use of amifostine can reduce the hematologic and nonhematologic toxic effects of this combination chemotherapy in these patients when compared to similar patients treated on POG-9049/CCG-8881 with the same combination chemotherapy. III. Determine the response rate of patients treated with this regimen. OUTLINE: Patients undergo surgical biopsy or resection. Patients then receive bleomycin IV over 10 minutes on day 1 and etoposide IV over 1 hour, amifostine IV over 15 minutes, and cisplatin IV over 1 hour on days 1-5. Treatment repeats every 3-4 weeks for 4 courses in the absence of unacceptable toxicity or disease progression. Patients who have no disease after 4 courses of chemotherapy receive no further treatment. Patients who have residual disease undergo second-look surgery. After surgery, patients who still have active tumor receive 2 additional courses of chemotherapy. Those patients who still have tumor after the 2 additional courses may have a third surgery. Patients are followed every month for 6 months, every 2 months for 6 months, every 6 months for 1 year, and then annually thereafter until death. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 1. 39 years.

Eligibility

Minimum age: N/A. Maximum age: 14 Years. Gender(s): Both.

Criteria:

DISEASE CHARACTERISTICS: Histologically confirmed, newly diagnosed, high-risk, extracranial germ cell tumors including the following: Yolk sac carcinoma (endodermal sinus tumor) Embryonal carcinoma Choriocarcinoma Teratoma with mixed malignant elements (malignant teratoma) OR Malignant recurrence (stage III or IV) of previously resected stage I extracranial, extragonadal tumor High-risk disease defined as stage III or IV extragonadal tumors Measurable disease by diagnostic imaging PATIENT CHARACTERISTICS: Age: Under 15 at time of diagnosis Performance status: Not specified Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 750/mm3 Platelet count greater than 75,000/mm3 Hepatic: Not specified Renal: Creatinine normal OR Glomerular filtration rate at least 50% of normal PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics

Locations and Contacts

Academisch Ziekenhuis Groningen, Groningen 9713 EZ, Netherlands

San Jorge Childrens Hospital, Santurce 00912, Puerto Rico

Swiss Pediatric Oncology Group Bern, Bern CH 3010, Switzerland

Clinique de Pediatrie, Geneva 1211, Switzerland

University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama 35294-3300, United States

MBCCOP - Gulf Coast, Mobile, Alabama 36688, United States

Alberta Children's Hospital, Calgary, Alberta T2T 5C7, Canada

Cross Cancer Institute, Edmonton, Alberta T6G 1Z2, Canada

Arizona Cancer Center, Tucson, Arizona 85724, United States

University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States

University of California San Diego Cancer Center, La Jolla, California 92093-0658, United States

Lucile Packard Children's Hospital at Stanford, Palo Alto, California 94304, United States

Sutter Cancer Center, Sacramento, California 95816, United States

University of California Davis Medical Center, Sacramento, California 95817, United States

Children's Hospital and Health Center, San Diego, California 92123-4282, United States

Kaiser Permanente-Southern California Permanente Medical Group, San Diego, California 92120, United States

Naval Medical Center - San Diego, San Diego, California 92134-3202, United States

Kaiser Permanente Medical Center - Santa Clara, Santa Clara, California 95051-5386, United States

Stanford University Medical Center, Stanford, California 94305-5408, United States

Yale Comprehensive Cancer Center, New Haven, Connecticut 06520-8028, United States

Walter Reed Army Medical Center, Washington, District of Columbia 20307-5000, United States

Shands Hospital and Clinics, University of Florida, Gainesville, Florida 32610-100277, United States

Nemours Children's Clinic, Jacksonville, Florida 32207, United States

Baptist Hospital of Miami, Miami, Florida 33176-2197, United States

Miami Children's Hospital, Miami, Florida 33155, United States

Sylvester Cancer Center, University of Miami, Miami, Florida 33136, United States

Walt Disney Memorial Cancer Institute, Orlando, Florida 32803, United States

CCOP - Florida Pediatric, Tampa, Florida 33682-7757, United States

St. Mary's Hospital, West Palm Beach, Florida 33407, United States

Emory University Hospital - Atlanta, Atlanta, Georgia 30322, United States

Cancer Research Center of Hawaii, Honolulu, Hawaii 96813, United States

Tripler Army Medical Center, Honolulu, Hawaii 96859-5000, United States

Children's Memorial Hospital, Chicago, Chicago, Illinois 60614, United States

Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois 60612, United States

Hope Children's Hospital, Oak Lawn, Illinois 60453, United States

Saint Jude Midwest Affiliate, Peoria, Illinois 61637, United States

University of Kansas Medical Center, Kansas City, Kansas 66160-7357, United States

CCOP - Wichita, Wichita, Kansas 67214-3882, United States

Via Christi Regional Medical Center, Wichita, Kansas 67214, United States

CCOP - Ochsner, New Orleans, Louisiana 70121, United States

MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana 70112, United States

Tulane University School of Medicine, New Orleans, Louisiana 70112, United States

Eastern Maine Medical Center, Bangor, Maine 04401, United States

Maine Children's Cancer Program, Portland, Maine 04101, United States

Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland 21201, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21231-2410, United States

Boston Floating Hospital Infants and Children, Boston, Massachusetts 02111, United States

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States

Massachusetts General Hospital Cancer Center, Boston, Massachusetts 02114, United States

University of Massachusetts Memorial Medical Center, Worcester, Massachusetts 01655, United States

Children's Hospital of Michigan, Detroit, Michigan 48201, United States

St. John's Hospital and Medical Center, Detroit, Michigan 48236, United States

Hurley Medical Center, Flint, Michigan 48503, United States

University of Mississippi Medical Center, Jackson, Mississippi 39216-4505, United States

Keesler Medical Center - Keesler AFB, Keesler AFB, Mississippi 39534-2576, United States

University of Missouri-Columbia Hospital and Clinics, Columbia, Missouri 65212, United States

Cardinal Glennon Children's Hospital, Saint Louis, Missouri 63104, United States

Washington University School of Medicine, Saint Louis, Missouri 63110, United States

Norris Cotton Cancer Center, Lebanon, New Hampshire 03756-0002, United States

CCOP - Northern New Jersey, Hackensack, New Jersey 07601, United States

Hackensack University Medical Center, Hackensack, New Jersey 07601, United States

University of New Mexico School of Medicine, Albuquerque, New Mexico 87131, United States

Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States

Schneider Children's Hospital, New Hyde Park, New York 11042, United States

Mount Sinai School of Medicine, New York, New York 10029, United States

University of Rochester Cancer Center, Rochester, New York 14642, United States

State University of New York Health Sciences Center - Stony Brook, Stony Brook, New York 11790-7775, United States

State University of New York - Upstate Medical University, Syracuse, New York 13210, United States

Mission Saint Joseph's Health System, Asheville, North Carolina 28801, United States

Carolinas Medical Center, Charlotte, North Carolina 28232-2861, United States

Presbyterian Healthcare, Charlotte, North Carolina 28233-3549, United States

Duke Comprehensive Cancer Center, Durham, North Carolina 27710, United States

East Carolina University School of Medicine, Greenville, North Carolina 27858-4354, United States

Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina 27157-1082, United States

Oklahoma Memorial Hospital, Oklahoma City, Oklahoma 73126-0307, United States

Natalie Warren Bryant Cancer Center, Tulsa, Oklahoma 74136, United States

Children's Hospital, Hamilton, Ontario L8N 3Z5, Canada

Children's Hospital of Eastern Ontario, Ottawa, Ontario K1H 8L1, Canada

Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada

CCOP - Columbia River Program, Portland, Oregon 97213, United States

Legacy Emanuel Hospital and Health Center, Portland, Oregon 97227, United States

St. Christopher's Hospital for Children, Philadelphia, Pennsylvania 19134-1095, United States

Hopital Sainte Justine, Montreal, Quebec H3T 1C5, Canada

McGill University Health Center - Montreal Children's Hospital, Montreal, Quebec H3H 1P3, Canada

Centre Hospitalier de L'Universite Laval, Sainte Foy, Quebec GIV 4G2, Canada

Medical University of South Carolina, Charleston, South Carolina 29425-0721, United States

Children's Hospital of Greenville Hospital System, Greenville, South Carolina 29605, United States

James H. Quillen College of Medicine, Johnson City, Tennessee 37614-0622, United States

Saint Jude Children's Research Hospital, Memphis, Tennessee 38105-2794, United States

Medical City Dallas Hospital, Dallas, Texas 75230, United States

Simmons Cancer Center - Dallas, Dallas, Texas 75235-9154, United States

Cook Children's Medical Center - Fort Worth, Fort Worth, Texas 76104, United States

University of Texas Medical Branch, Galveston, Texas 77555-0209, United States

Baylor College of Medicine, Houston, Texas 77030, United States

San Antonio Military Pediatric Cancer and Blood Disorders Center, Lackland Air Force Base, Texas 78236-5300, United States

MBCCOP - South Texas Pediatric, San Antonio, Texas 78229-3900, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas 78284-7811, United States

Scott and White Clinic, Temple, Texas 76508, United States

Vermont Cancer Center, Burlington, Vermont 05401-3498, United States

Royal Children's Hospital, Parkville, Victoria 3052, Australia

Cancer Center at the University of Virginia, Charlottesville, Virginia 22908, United States

Inova Fairfax Hospital, Falls Church, Virginia 22042-3300, United States

Naval Medical Center, Portsmouth, Portsmouth, Virginia 23708-2197, United States

Massey Cancer Center, Richmond, Virginia 23298-0037, United States

Carilion Roanoke Community Hospital, Roanoke, Virginia 24029, United States

Madigan Army Medical Center, Tacoma, Washington 98431-5000, United States

West Virginia University Medical School-Charleston, Charleston, West Virginia 25304, United States

West Virginia University Hospitals, Morgantown, West Virginia 26506-9300, United States

St. Vincent Hospital, Green Bay, Wisconsin 54307-3508, United States

Midwest Children's Cancer Center, Milwaukee, Wisconsin 53226, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: April 2000
Last updated: July 3, 2013

Page last updated: August 20, 2015

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