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

NCT00003811 | Completed Phase 2

• 3 other identifiers: 9749POG-9749CDR0000066956
• Study Type: interventional
• Target: 27
• Locations: 6 countries
• Sites: 110

Brief 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.

Conditions

Childhood Germ Cell Tumor; Drug/Agent Toxicity by Tissue/Organ; Extragonadal Germ Cell Tumor; Ovarian Cancer

Keywords

drug/agent toxicity by tissue/organ; childhood teratoma; childhood malignant testicular germ cell tumor; childhood malignant ovarian germ cell tumor; childhood extragonadal germ cell tumor; recurrent childhood malignant germ cell tumor

Outcome Measures

Primary Outcomes (1)

• Feasibility from Efficacy Standpoint

  The hazard rate is constant over 1.39 years, then the probability of the occurrence of a failure within this time interval follows a Poisson distribution. The table below shows the trial feasibility probabilities associated with those failure rates. We define the probability of feasibility as the probability of observing a total of at most less than three failures in 25 patient years of follow-up.

Secondary Outcomes (1)

• Assessment of Reduction in Toxicity

Interventions

bleomycin sulfate BIOLOGICAL

amifostine trihydrate DRUG

cisplatin DRUG

etoposide DRUG

conventional surgery PROCEDURE

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (110)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

MBCCOP - Gulf Coast

Mobile, Alabama, 36688, United States

Location

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

University of California San Diego Cancer Center

La Jolla, California, 92093-0658, United States

Location

Lucile Packard Children's Hospital at Stanford

Palo Alto, California, 94304, United States

Location

Sutter Cancer Center

Sacramento, California, 95816, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Kaiser Permanente-Southern California Permanente Medical Group

San Diego, California, 92120, United States

Location

Children's Hospital and Health Center

San Diego, California, 92123-4282, United States

Location

Naval Medical Center - San Diego

San Diego, California, 92134-3202, United States

Location

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051-5386, United States

Location

Stanford University Medical Center

Stanford, California, 94305-5408, United States

Location

Yale Comprehensive Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5000, United States

Location

Shands Hospital and Clinics, University of Florida

Gainesville, Florida, 32610-100277, United States

Location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Sylvester Cancer Center, University of Miami

Miami, Florida, 33136, United States

Location

Miami Children's Hospital

Miami, Florida, 33155, United States

Location

Baptist Hospital of Miami

Miami, Florida, 33176-2197, United States

Location

Walt Disney Memorial Cancer Institute

Orlando, Florida, 32803, United States

Location

CCOP - Florida Pediatric

Tampa, Florida, 33682-7757, United States

Location

St. Mary's Hospital

West Palm Beach, Florida, 33407, United States

Location

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322, United States

Location

Cancer Research Center of Hawaii

Honolulu, Hawaii, 96813, United States

Location

Tripler Army Medical Center

Honolulu, Hawaii, 96859-5000, United States

Location

Rush-Presbyterian-St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

Children's Memorial Hospital, Chicago

Chicago, Illinois, 60614, United States

Location

Hope Children's Hospital

Oak Lawn, Illinois, 60453, United States

Location

Saint Jude Midwest Affiliate

Peoria, Illinois, 61637, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Maine Children's Cancer Program

Portland, Maine, 04101, United States

Location

Marlene & Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, 21201, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Boston Floating Hospital Infants and Children

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

St. John's Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Keesler Medical Center - Keesler AFB

Keesler Air Force Base, Mississippi, 39534-2576, United States

Location

University of Missouri-Columbia Hospital and Clinics

Columbia, Missouri, 65212, United States

Location

Cardinal Glennon Children's Hospital

St Louis, Missouri, 63104, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756-0002, United States

Location

CCOP - Northern New Jersey

Hackensack, New Jersey, 07601, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

University of New Mexico School of Medicine

Albuquerque, New Mexico, 87131, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Schneider Children's Hospital

New Hyde Park, New York, 11042, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

University of Rochester Cancer Center

Rochester, New York, 14642, United States

Location

State University of New York Health Sciences Center - Stony Brook

Stony Brook, New York, 11790-7775, United States

Location

State University of New York - Upstate Medical University

Syracuse, New York, 13210, United States

Location

Mission Saint Joseph's Health System

Asheville, North Carolina, 28801, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Presbyterian Healthcare

Charlotte, North Carolina, 28233-3549, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

East Carolina University School of Medicine

Greenville, North Carolina, 27858-4354, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Oklahoma Memorial Hospital

Oklahoma City, Oklahoma, 73126-0307, United States

Location

Natalie Warren Bryant Cancer Center

Tulsa, Oklahoma, 74136, United States

Location

CCOP - Columbia River Program

Portland, Oregon, 97213, United States

Location

Legacy Emanuel Hospital and Health Center

Portland, Oregon, 97227, United States

Location

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134-1095, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-0721, United States

Location

Children's Hospital of Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

James H. Quillen College of Medicine

Johnson City, Tennessee, 37614-0622, United States

Location

Saint Jude Children's Research Hospital

Memphis, Tennessee, 38105-2794, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

Cook Children's Medical Center - Fort Worth

Fort Worth, Texas, 76104, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0209, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

San Antonio Military Pediatric Cancer and Blood Disorders Center

Lackland Air Force Base, Texas, 78236-5300, United States

Location

MBCCOP - South Texas Pediatric

San Antonio, Texas, 78229-3900, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

Location

Scott and White Clinic

Temple, Texas, 76508, United States

Location

Vermont Cancer Center

Burlington, Vermont, 05401-3498, United States

Location

Cancer Center at the University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042-3300, United States

Location

Naval Medical Center, Portsmouth

Portsmouth, Virginia, 23708-2197, United States

Location

Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

Carilion Roanoke Community Hospital

Roanoke, Virginia, 24029, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431-5000, United States

Location

West Virginia University Medical School-Charleston

Charleston, West Virginia, 25304, United States

Location

West Virginia University Hospitals

Morgantown, West Virginia, 26506-9300, United States

Location

St. Vincent Hospital

Green Bay, Wisconsin, 54307-3508, United States

Location

Midwest Children's Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Royal Children's Hospital

Parkville, Victoria, 3052, Australia

Location

Alberta Children's Hospital

Calgary, Alberta, T2T 5C7, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

McGill University Health Center - Montreal Children's Hospital

Montreal, Quebec, H3H 1P3, Canada

Location

Hopital Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Centre Hospitalier de L'Universite Laval

Sainte-Foy, Quebec, GIV 4G2, Canada

Location

Academisch Ziekenhuis Groningen

Groningen, 9713 EZ, Netherlands

Location

San Jorge Childrens Hospital

Santurce, 00912, Puerto Rico

Location

Swiss Pediatric Oncology Group Bern

Bern, CH 3010, Switzerland

Location

Clinique de Pediatrie

Geneva, 1211, Switzerland

Location

Related Publications (1)

• Marina N, Chang KW, Malogolowkin M, London WB, Frazier AL, Womer RB, Rescorla F, Billmire DF, Davis MM, Perlman EJ, Giller R, Lauer SJ, Olson TA; Children's Oncology Group. Amifostine does not protect against the ototoxicity of high-dose cisplatin combined with etoposide and bleomycin in pediatric germ-cell tumors: a Children's Oncology Group study. Cancer. 2005 Aug 15;104(4):841-7. doi: 10.1002/cncr.21218.

  PMID: 15999362 RESULT

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; Ovarian Neoplasms; Teratoma; Testicular Neoplasms; Ovarian Germ Cell Cancer

Interventions

Bleomycin; Amifostine; Cisplatin; Etoposide

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Genital Neoplasms, Male; Genital Diseases, Male; Male Urogenital Diseases; Testicular Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Organothiophosphates; Organophosphates; Organophosphorus Compounds; Organic Chemicals; Organothiophosphorus Compounds; Sulfur Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides

Study Officials

• Neyssa M. Marina, MD

  Stanford University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: December 10, 2003
• Study Start: April 1, 2000
• Primary Completion: October 1, 2004
• Study Completion: September 1, 2007
• Last Updated: July 4, 2013

Record last verified: 2013-07

Locations

PR (1); CH (2); AU (1); NL (1); CA (8); US (97)