Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187109
Status:
COMPLETED
Last Update Posted:
2008-04-10
First Post:
2005-09-13
Brief Title:
Recombinant Human Thrombopoietin in Children Receiving Ifosfamide Carboplatin and Etoposide Chemotherapy
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
A Phase III Trial of Recombinant Human Thrombopoietin in Children With Malignant Solid Tumors and Lymphoma Receiving Ifosfamide Carboplatin and Etoposide
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Life-threatening thrombocytopenia low platelet count and neutropenia low white blood count remain the major dose-limiting toxicities following chemotherapy treatment for cancer The only remedy for thrombocytopenia at present is platelet transfusion which is effective in preventing life-threatening hemorrhage but may lead to other complications Preclinical studies and studies in adults have shown recombinant human thrombopoietin rhTPO to be effective in stimulating platelet production The initial phase of this trial will evaluate the safety of rhTPO use immediately after chemotherapy with ifosfamide carboplatin and etoposide in children with solid tumors and lymphomas The second phase of the study will evaluate the effectiveness of rhTPO in decreasing the duration of low platelet count after chemotherapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None