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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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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
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Secondary ID [1]
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POG-9749
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Secondary ID [2]
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9749
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Childhood Germ Cell Tumor
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Drug/Agent Toxicity by Tissue/Organ
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Extragonadal Germ Cell Tumor
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Ovarian Cancer
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Condition category
Condition code
Cancer
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Ovarian and primary peritoneal
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Cancer
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Testicular
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Cancer
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Other cancer types
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Feasibility from Efficacy Standpoint
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Assessment method [1]
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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.
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Timepoint [1]
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Secondary outcome [1]
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Assessment of Reduction in Toxicity
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Assessment method [1]
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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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Timepoint [1]
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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
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Minimum age
No limit
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Maximum age
14
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Intervention assignment
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2000
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2007
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Sample size
Target
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Accrual to date
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Final
27
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Royal Children's Hospital - Parkville
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Recruitment postcode(s) [1]
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3052 - Parkville
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Recruitment outside Australia
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United States of America
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Alabama
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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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Bern
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Geneva
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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Address
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Government body
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Name [1]
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National Cancer Institute (NCI)
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT00003811
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Trial related presentations / publications
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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Public notes
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Contacts
Principal investigator
Name
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Neyssa M. Marina, MD
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Address
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Stanford University
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Marina N, Chang KW, Malogolowkin M, London WB, Fra...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT00003811
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