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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00187109 |
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Date of registration:
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13/09/2005 |
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Primary sponsor: |
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Public title:
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Recombinant Human Thrombopoietin in Children Receiving Ifosfamide, Carboplatin, and Etoposide Chemotherapy
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Scientific title:
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A Phase I/II Trial of Recombinant Human Thrombopoietin in Children With Malignant Solid Tumors and Lymphoma Receiving Ifosfamide, Carboplatin and Etoposide |
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Date of first enrolment:
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June 2000 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00187109 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Najat C. Daw, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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St. Jude Children's Research Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of recurrent, refractory, or previously untreated malignant solid tumor or
recurrent/refractory lymphoma for which Ifosfamide, Carboplatin, and Etoposide
chemotherapy is the most appropriate treatment.
- Adequate liver and kidney function.
- Adequate performance status.
Age minimum:
N/A
Age maximum:
21 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Germ Cell Tumors
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Hepatic Cancer
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Neuroblastoma
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Osteosarcoma
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Rhabdomyosarcoma
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Intervention(s)
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Drug: Recombinant Human Thrombopoietin
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Primary Outcome(s)
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To evaluate the safety of recombinant human thrombopoietin following chemotherapy which includes ifosfamide, carboplatin and etoposide for solid tumors and lymphoma.
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To evaluate whether recombinant human thrombopoietin will reduce the time necessary for platelet counts to recover following chemotherapy.
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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