Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003597
Status:
COMPLETED
Last Update Posted:
2014-07-24
First Post:
1999-11-01
Brief Title:
Colony-Stimulating Factors in Treating Children With Recurrent or Refractory Solid Tumors
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase I Study of Thrombopoietin rhTPO Plus G-CSF in Children Receiving Ifosfamide Carboplatin and Etoposide ICE Chemotherapy for Recurrent or Refractory Solid Tumors
Status:
COMPLETED
Status Verified Date:
2014-07
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Colony-stimulating factors such as thrombopoietin and G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of chemotherapy
PURPOSE Phase I trial to study the effectiveness of colony-stimulating factors in treating children who have recurrent or refractory solid tumors and who are receiving chemotherapy
PURPOSE Phase I trial to study the effectiveness of colony-stimulating factors in treating children who have recurrent or refractory solid tumors and who are receiving chemotherapy
Detailed Description:
OBJECTIVES
Determine the pharmacokinetics and toxicities associated with the administration of recombinant human thrombopoietin in children with solid tumors receiving myelosuppressive chemotherapy with ifosfamide carboplatin and etoposide ICE
Determine a safe dose of recombinant human thrombopoietin with filgrastim G-CSF in this patient population
Evaluate the time to platelet count recovery following chemotherapy in this patient population
Evaluate the depth and duration of neutropenia and thrombocytopenia and the number of platelet transfusion events in this patient population
OUTLINE This is a dose escalation study of recombinant human thrombopoietin
All patients receive chemotherapy consisting of carboplatin IV over 60 minutes on days 0 and 1 and etoposide and ifosfamide IV over 60 minutes on days 0-4 Chemotherapy is continued in the absence of disease progression or unacceptable toxicity for a maximum of 6 courses every 21 days
Cohorts of 3-6 patients each receive escalating doses of recombinant human thrombopoietin IV on days 4 6 8 10 and 12 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which fewer than 2 patients experience dose limiting toxicity After the MTD is determined an additional cohort of patients are treated at this dose level every other day on days 4-20 Patients receive filgrastim G-CSF subcutaneously beginning on day 5 and continuing until absolute neutrophil count is greater than 1000mm3 for 2 consecutive days or day 33
PROJECTED ACCRUAL A total of 24 evaluable patients will be accrued for this study
Determine the pharmacokinetics and toxicities associated with the administration of recombinant human thrombopoietin in children with solid tumors receiving myelosuppressive chemotherapy with ifosfamide carboplatin and etoposide ICE
Determine a safe dose of recombinant human thrombopoietin with filgrastim G-CSF in this patient population
Evaluate the time to platelet count recovery following chemotherapy in this patient population
Evaluate the depth and duration of neutropenia and thrombocytopenia and the number of platelet transfusion events in this patient population
OUTLINE This is a dose escalation study of recombinant human thrombopoietin
All patients receive chemotherapy consisting of carboplatin IV over 60 minutes on days 0 and 1 and etoposide and ifosfamide IV over 60 minutes on days 0-4 Chemotherapy is continued in the absence of disease progression or unacceptable toxicity for a maximum of 6 courses every 21 days
Cohorts of 3-6 patients each receive escalating doses of recombinant human thrombopoietin IV on days 4 6 8 10 and 12 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which fewer than 2 patients experience dose limiting toxicity After the MTD is determined an additional cohort of patients are treated at this dose level every other day on days 4-20 Patients receive filgrastim G-CSF subcutaneously beginning on day 5 and continuing until absolute neutrophil count is greater than 1000mm3 for 2 consecutive days or day 33
PROJECTED ACCRUAL A total of 24 evaluable patients will be accrued for this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000066668 | None | None | None |
| CCG-09717 | None | None | None |