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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00003811




Registration number
NCT00003811
Ethics application status
Date submitted
1/11/1999
Date registered
10/12/2003
Date last updated
4/07/2013

Titles & IDs
Public title
Combination Chemotherapy Plus Amifostine in Treating Children With Malignant Germ Cell Tumors
Scientific 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
Secondary ID [1] 0 0
POG-9749
Secondary ID [2] 0 0
9749
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood Germ Cell Tumor 0 0
Drug/Agent Toxicity by Tissue/Organ 0 0
Extragonadal Germ Cell Tumor 0 0
Ovarian Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Testicular
Cancer 0 0 0 0
Other cancer types
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - bleomycin sulfate
Treatment: Drugs - amifostine trihydrate
Treatment: Drugs - cisplatin
Treatment: Drugs - etoposide
Treatment: Surgery - conventional surgery

Other interventions: bleomycin sulfate


Treatment: Drugs: amifostine trihydrate


Treatment: Drugs: cisplatin


Treatment: Drugs: etoposide


Treatment: Surgery: conventional surgery
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility from Efficacy Standpoint
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Assessment of Reduction in Toxicity
Timepoint [1] 0 0

Eligibility
Key inclusion 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
Minimum age
No limit
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2007
Sample size
Target
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Children's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Arkansas
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California
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Connecticut
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District of Columbia
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Florida
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Georgia
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Hawaii
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Illinois
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Kansas
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Louisiana
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Maine
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Maryland
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Massachusetts
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Michigan
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Mississippi
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Missouri
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New Hampshire
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New Jersey
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New Mexico
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New York
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North Carolina
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Vermont
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Virginia
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Washington
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West Virginia
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Wisconsin
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Canada
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Alberta
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Canada
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Ontario
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Canada
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Quebec
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Netherlands
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Groningen
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Puerto Rico
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Santurce
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Switzerland
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Bern
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Switzerland
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Geneva

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00003811
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Neyssa M. Marina, MD
Address 0 0
Stanford University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00003811