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| ID | Type | Description | Link |
|---|---|---|---|
| POG-9749 | Other Identifier | Pediatric Oncology Group | |
| CDR0000066956 | Other Identifier | Clinical Trials.gov |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bleomycin sulfate | Biological | |||
| amifostine trihydrate | Drug | |||
| cisplatin | Drug | |||
| etoposide | Drug | |||
| conventional surgery | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Reduction in Toxicity | Descriptive statistics will be performed for nephrotoxicity, hematologic and pulmonary toxicities, and inference will be performed for ototoxicity. Frequency tables of the occurrences of toxicities by grade will be tabulated for ANC and platelets. To assess nephrotoxicity and pulmonary toxicity, descriptive statistics will be calculated for GFR and DLCO, respectively. These statistics will be compared to the corresponding summaries on the appropriate population of patients from POG 9049/CCG 8881. |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Neyssa M. Marina, MD | Stanford University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama | 35294-3300 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15999362 | Result | 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. |
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| MBCCOP - Gulf Coast |
| Mobile |
| Alabama |
| 36688 |
| United States |
| 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 |
| Kaiser Permanente-Southern California Permanente Medical Group | San Diego | California | 92120 | United States |
| Children's Hospital and Health Center | San Diego | California | 92123-4282 | 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 D.C. | 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 |
| Sylvester Cancer Center, University of Miami | Miami | Florida | 33136 | United States |
| Miami Children's Hospital | Miami | Florida | 33155 | United States |
| Baptist Hospital of Miami | Miami | Florida | 33176-2197 | 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 |
| Rush-Presbyterian-St. Luke's Medical Center | Chicago | Illinois | 60612 | United States |
| Children's Memorial Hospital, Chicago | Chicago | Illinois | 60614 | 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 |
| MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | United States |
| CCOP - Ochsner | New Orleans | Louisiana | 70121 | 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 |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | 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 Air Force Base | Mississippi | 39534-2576 | United States |
| University of Missouri-Columbia Hospital and Clinics | Columbia | Missouri | 65212 | United States |
| Cardinal Glennon Children's Hospital | St Louis | Missouri | 63104 | United States |
| Washington University School of Medicine | St 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 |
| 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 |
| 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 |
| 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 |
| Royal Children's Hospital | Parkville | Victoria | 3052 | Australia |
| Alberta Children's Hospital | Calgary | Alberta | T2T 5C7 | Canada |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| 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 |
| McGill University Health Center - Montreal Children's Hospital | Montreal | Quebec | H3H 1P3 | Canada |
| Hopital Sainte Justine | Montreal | Quebec | H3T 1C5 | Canada |
| Centre Hospitalier de L'Universite Laval | Sainte-Foy | Quebec | GIV 4G2 | Canada |
| 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 |
| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D010051 | Ovarian Neoplasms |
| D013724 | Teratoma |
| D013736 | Testicular Neoplasms |
| C562841 | Ovarian Germ Cell Cancer |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| D013733 | Testicular Diseases |
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| ID | Term |
|---|---|
| D001761 | Bleomycin |
| D004999 | Amifostine |
| D002945 | Cisplatin |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D063086 | Organothiophosphates |
| D010755 | Organophosphates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D009946 | Organothiophosphorus Compounds |
| D013457 | Sulfur Compounds |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
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