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Surgery and Combination Chemotherapy in Treating Children With Extracranial 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 Embryonal Tumor; Childhood Extracranial Germ Cell Tumor; Childhood Extragonadal Germ Cell Tumor; Childhood Malignant Ovarian Germ Cell Tumor; Childhood Malignant Testicular Germ Cell Tumor; Childhood Teratoma; Ovarian Embryonal Carcinoma; Ovarian Yolk Sac Tumor; Stage II Malignant Testicular Germ Cell Tumor; Stage IIA Ovarian Germ Cell Tumor; Stage IIB Ovarian Germ Cell Tumor; Stage IIC Ovarian Germ Cell Tumor; Stage III Malignant Testicular Germ Cell Tumor; Stage IIIA Ovarian Germ Cell Tumor; Stage IIIB Ovarian Germ Cell Tumor; Stage IIIC Ovarian Germ Cell Tumor; Testicular Choriocarcinoma and Yolk Sac Tumor; Testicular Embryonal Carcinoma

Intervention: conventional surgery (Procedure); cisplatin (Drug); etoposide (Drug); bleomycin sulfate (Biological); laboratory biomarker analysis (Other)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Children's Oncology Group

Official(s) and/or principal investigator(s):
Anne Frazier, MD, Principal Investigator, Affiliation: Children's Oncology Group

Summary

This phase III trial is studying surgery followed by combination chemotherapy to see how well it works in treating children with germ cell tumors that are not located in the head. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them after surgery, may kill any remaining tumor cells following surgery. It is not yet known whether combination chemotherapy is effective in decreasing the recurrence of childhood germ cell tumors.

Clinical Details

Official title: A Phase III Study Of Reduced Therapy In The Treatment Of Children With Low And Intermediate Risk Extracranial Germ Cell Tumors

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Event-free survival (EFS) of at least 92% (for intermediate-risk tumors only) defined as the first occurrence of relapse, progressive disease, second malignancy, or death after the start of protocol-specified chemotherapy

Overall survival (OS) of at least 95% (both low-risk and intermediate-risk tumors)

Days of hospitalization and number of doctor visits

Toxicity as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0

Detailed description: OBJECTIVES: I. Determine whether children with newly diagnosed low- or intermediate-risk extracranial germ cell tumors (GCTs) can maintain a 3-year event-free survival of at least 92% (for intermediate-risk tumors only) and overall survival of at least 95% (both low-risk and intermediate-risk tumors) after treatment with surgery followed by compressed cisplatin, etoposide, and bleomycin (low-risk disease closed to accrual as of 01/20/10). II. Determine the percentage of patients with stage I ovarian or stage I testicular GCTs for whom chemotherapy can be eliminated. III. Determine the percentage of intermediate-risk patients who require only 3 courses of therapy. IV. Determine the acute toxic effects of compressed therapy in these patients. V. Determine the long-term sequelae in patients treated with this regimen. VI. Determine the number of hospital days and total drug doses required for patients treated with compressed therapy. VII. Compare the number of protocol-directed treatment days used in CCG-8882 vs the number of treatment days used in this study. VIII. Determine the cytogenetic and molecular genetic features in patients treated with this regimen. OUTLINE: Patients are stratified according to disease risk (low vs intermediate). SURGERY: Patients undergo surgical resection. Low-risk disease: Patients with gonadal primaries and no evidence of disease after surgery undergo monitoring for disease progression. Patients who remain disease free receive no further treatment. Patients who have disease progression after surgery receive compressed induction chemotherapy. (closed to accrual as of 01/20/2010) Intermediate-risk disease: After surgery, patients proceed to compressed induction chemotherapy. COMPRESSED INDUCTION CHEMOTHERAPY: Patients receive cisplatin IV over 90 minutes and etoposide IV over 90 minutes on days 1-3 and bleomycin IV over ≥ 10 minutes on day 1. Treatment repeats every 3 weeks for 3 courses (weeks 0, 3, and 6). After completion of compressed induction chemotherapy, patients who have no change in disease status or disease progression are removed from study. Patients with no evidence of disease receive no further therapy. Patients with a partial response or who have abnormal tumor markers proceed to second-look surgery and/or 3 more courses of compressed consolidation chemotherapy. SECOND-LOOK SURGERY: Patients undergo surgical resection of residual tumor. After surgery, patients who are in pathologic complete response and have normal tumor markers receive no further therapy. Patients who remain with a partial response after surgery receive compressed consolidation chemotherapy. COMPRESSED CONSOLIDATION CHEMOTHERAPY: Patients receive cisplatin, etoposide, and bleomycin as in induction chemotherapy in weeks 10, 13, and 16. Patients are followed up monthly for 6 months, every 3 months for 18 months, and then annually for up to 10 years.

Eligibility

Minimum age: N/A. Maximum age: 21 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Extracranial germ cell tumor that contains 1 of the following malignant histologies:

NOTE: Mixed germ cell tumors that include mature/immature teratoma are eligible provided 1 of the 3 histologies listed above is also present in the tumor.

- Yolk sac tumor

- Embryonal carcinoma

- Choriocarcinoma

- Low-risk disease (closed to accrual as of 01/20/10)

- Stage I gonadal tumors (ovarian and testicular)

- Must have undergone complete surgical and radiologic staging to exclude the

possibility of > stage I disease

- Intermediate-risk disease

- Stage II, III, or IV malignant testicular GCT

- Stage II or III malignant ovarian GCT

- Stage I or II malignant extragonadal GCT

- Previously stage I gonadal patients who have relapsed on the low-risk

(observation) stratum of this study(closed to accrual as of 01/20/10)

- Patients with immature teratoma or mature teratoma who relapse with a malignant

component

- No patients with any of the following diagnoses:

- Stage IV ovarian and stage III-IV extragonadal GCT

- Intracranial GCT

- Pure mature or immature teratoma, pure dysgerminoma, or seminoma

- Patients with a non-germ cell component in their GCT (e. g., primitive

neuroectodermal tumors or rhabdomyosarcoma)

- Alpha-fetoprotein and beta human chorionic gonadotropin tumor markers known

- If > 5 days have elapsed from the time of obtaining original markers, tumor

markers must be repeated before enrollment of low-risk patients and before initiating therapy in intermediate-risk patients (the results of the repeated tumor markers do not have to be known at the time of study enrollment)

- Must be enrolled within 6 weeks of original diagnostic surgery

- Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR a serum creatinine based on

age/gender as follows:

- ≤ 0. 4 mg/dL (for patients 1 to 5 months of age)

- ≤ 0. 5 mg/dL (for patients 6 to 11 months of age)

- ≤ 0. 6 mg/dL (for patients 1 year of age)

- ≤ 0. 8 mg/dL (for patients 2 to 5 years of age)

- ≤ 1. 0 mg/dL (for patients 6 to 9 years of age)

- ≤ 1. 2 mg/dL (for patients 10 to 12 years of age)

- ≤ 1. 4 mg/dL (for female patients ≥ 13 years of age)

- ≤ 1. 5 mg/dL (for male patients 13 to 15 years of age)

- ≤ 1. 7 mg/dL (for male patients ≥ 16 years of age)

- No prior chemotherapy

- No prior radiotherapy

Locations and Contacts

San Jorge Children's Hospital, Santurce 00912, Puerto Rico

Swiss Pediatric Oncology Group - Geneva, Geneva 1205, Switzerland

University of Alabama at Birmingham, Birmingham, Alabama 35294, United States

Alberta Children's Hospital, Calgary, Alberta T3B 6A8, Canada

University of Alberta Hospital, Edmonton, Alberta T6G 2B7, Canada

Phoenix Childrens Hospital, Phoenix, Arizona 85016, United States

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

Starship Children's Hospital, Grafton, Auckland 1145, New Zealand

British Columbia Children's Hospital, Vancouver, British Columbia V6H 3V4, Canada

Southern California Permanente Medical Group, Downey, California 90242, United States

Loma Linda University Medical Center, Loma Linda, California 92354, United States

Miller Children's Hospital, Long Beach, California 90806, United States

Children's Hospital Los Angeles, Los Angeles, California 90027, United States

Children's Hospital Central California, Madera, California 93636-8762, United States

Children's Hospital and Research Center at Oakland, Oakland, California 94609-1809, United States

Kaiser Permanente-Oakland, Oakland, California 94611, United States

Childrens Hospital of Orange County, Orange, California 92868-3874, United States

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

Sutter General Hospital, Sacramento, California 95816, United States

Rady Children's Hospital - San Diego, San Diego, California 92123, United States

University of California San Francisco Medical Center-Parnassus, San Francisco, California 94143, United States

Children's Hospital Colorado, Aurora, Colorado 80045, United States

Connecticut Children's Medical Center, Hartford, Connecticut 06106, United States

Yale University, New Haven, Connecticut 06520-8032, United States

Alfred I duPont Hospital for Children, Wilmington, Delaware 19803, United States

Children's National Medical Center, Washington, District of Columbia 20010, United States

Broward Health Medical Center, Fort Lauderdale, Florida 33316, United States

Lee Memorial Health System, Fort Myers, Florida 33901, United States

University of Florida, Gainesville, Florida 32610, United States

Memorial Healthcare System - Joe DiMaggio Children's Hospital, Hollywood, Florida 33021, United States

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

University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida 33136, United States

All Children's Hospital, Saint Petersburg, Florida 33701, United States

Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia 30322, United States

Memorial Health University Medical Center, Savannah, Georgia 31403, United States

University of Hawaii, Honolulu, Hawaii 96813, United States

Saint Luke's Mountain States Tumor Institute, Boise, Idaho 83712, United States

Childrens Memorial Hospital, Chicago, Illinois 60614, United States

Loyola University Medical Center, Maywood, Illinois 60153, United States

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

Saint Jude Midwest Affiliate, Peoria, Illinois 61602, United States

Southern Illinois University, Springfield, Illinois 62702, United States

University of Kentucky, Lexington, Kentucky 40536, United States

Kosair Children's Hospital, Louisville, Kentucky 40202, United States

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

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

Baystate Medical Center, Springfield, Massachusetts 01199, United States

C S Mott Children's Hospital, Ann Arbor, Michigan 48109, United States

Saint John Hospital and Medical Center, Detroit, Michigan 48236, United States

Wayne State University, Detroit, Michigan 48202, United States

Hurley Medical Center, Flint, Michigan 48502, United States

Helen DeVos Children's Hospital at Spectrum Health, Grand Rapids, Michigan 49503, United States

Michigan State University - Breslin Cancer Center, Lansing, Michigan 48910, United States

Children's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis, Minnesota 55404, United States

University of Minnesota Medical Center-Fairview, Minneapolis, Minnesota 55455, United States

Mayo Clinic, Rochester, Minnesota 55905, United States

The Childrens Mercy Hospital, Kansas City, Missouri 64108, United States

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

Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States

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

Saint Peter's University Hospital, New Brunswick, New Jersey 08901, United States

UMDNJ - Robert Wood Johnson University Hospital, New Brunswick, New Jersey 08903, United States

Newark Beth Israel Medical Center, Newark, New Jersey 07112, United States

The Children's Hospital at Westmead, Sydney, New South Wales 2145, Australia

Albany Medical Center, Albany, New York 12208, United States

Montefiore Medical Center, Bronx, New York 10467-2490, United States

Brooklyn Hospital Center, Brooklyn, New York 11201, United States

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

The Steven and Alexandra Cohen Children's Medical Center of New York, New Hyde Park, New York 11040, United States

Columbia University Medical Center, New York, New York 10032, United States

New York University Langone Medical Center, New York, New York 10016, United States

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

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

New York Medical College, Valhalla, New York 10595, United States

Mission Hospitals Inc, Asheville, North Carolina 28801, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States

Sanford Medical Center-Fargo, Fargo, North Dakota 58122, United States

Children's Hospital Medical Center of Akron, Akron, Ohio 44308, United States

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229, United States

Rainbow Babies and Childrens Hospital, Cleveland, Ohio 44106, United States

Nationwide Children's Hospital, Columbus, Ohio 43205, United States

The Children's Medical Center of Dayton, Dayton, Ohio 45404, United States

Mercy Children's Hospital, Toledo, Ohio 43608, United States

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73104, United States

Chedoke-McMaster Hospitals, Hamilton, Ontario L8S 4L8, Canada

Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston, Ontario K7L 5P9, Canada

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

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

Oregon Health and Science University, Portland, Oregon 97239, United States

Geisinger Medical Center, Danville, Pennsylvania 17822-2001, United States

Penn State Hershey Children's Hospital, Hershey, Pennsylvania 17033, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States

Saint Christopher's Hospital for Children, Philadelphia, Pennsylvania 19134, United States

Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania 15224, United States

Hospital Sainte-Justine, Montreal, Quebec H3T 1C5, Canada

Centre Hospitalier Universitaire de Quebec, Ste-Foy, Quebec G1V 4G2, Canada

Allan Blair Cancer Centre, Regina, Saskatchewan S4T 7T1, Canada

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

Palmetto Health Richland, Columbia, South Carolina 29203, United States

T C Thompson Children's Hospital, Chattanooga, Tennessee 37403, United States

East Tennessee Childrens Hospital, Knoxville, Tennessee 37916, United States

St. Jude Children's Research Hospital, Memphis, Tennessee 38105, United States

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee 37232, United States

Texas Tech University Health Science Center-Amarillo, Amarillo, Texas 79106, United States

Dell Children's Medical Center of Central Texas, Austin, Texas 78723, United States

Driscoll Children's Hospital, Corpus Christi, Texas 78411, United States

University of Texas Southwestern Medical Center, Dallas, Texas 75390, United States

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

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

M D Anderson Cancer Center, Houston, Texas 77030, United States

Covenant Children's Hospital, Lubbock, Texas 79410, United States

Methodist Children's Hospital of South Texas, San Antonio, Texas 78229, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas 78229-3900, United States

Scott and White Memorial Hospital, Temple, Texas 76508, United States

Primary Children's Medical Center, Salt Lake City, Utah 84113, United States

University of Vermont, Burlington, Vermont 05401, United States

Childrens Hospital-King's Daughters, Norfolk, Virginia 23507, United States

Carilion Clinic Children's Hospital, Roanoke, Virginia 24014, United States

Seattle Children's Hospital, Seattle, Washington 98105, United States

West Virginia University Charleston, Charleston, West Virginia 25304, United States

Princess Margaret Hospital for Children, Perth, Western Australia 6008, Australia

Saint Vincent Hospital, Green Bay, Wisconsin 54301, United States

University of Wisconsin Hospital and Clinics, Madison, Wisconsin 53792, United States

Marshfield Clinic, Marshfield, Wisconsin 54449, United States

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

Additional Information

Starting date: November 2003
Last updated: March 4, 2015

Page last updated: August 20, 2015

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