Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107458
Status:
COMPLETED
Last Update Posted:
2014-08-07
First Post:
2005-04-05
Brief Title:
Valproic Acid in Treating Young Patients With Recurrent or Refractory Solid Tumors or CNS Tumors
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase I Study of Valproic Acid in Children With RecurrentProgressive Solid Tumors Including CNS Tumors
Status:
COMPLETED
Status Verified Date:
2014-08
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 such as valproic acid work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Valproic acid may also stop the growth of solid tumors or CNS tumors by blocking blood flow to the tumor
PURPOSE This phase I trial is studying the side effects and best dose of valproic acid in treating patients with recurrent or refractory solid tumors or CNS tumors
PURPOSE This phase I trial is studying the side effects and best dose of valproic acid in treating patients with recurrent or refractory solid tumors or CNS tumors
Detailed Description:
OBJECTIVES
Primary
Determine the toxic effects of valproic acid VPA administered at doses required to maintain serum trough VPA concentrations of 100-150 mcgmL or 150-200 mcgmL in young patients with recurrent or refractory solid tumors or CNS tumors
Secondary
Determine the steady-state serum trough concentration of free and total VPA at the targeted total trough VPA concentration in these patients
Determine the steady state histone acetylation status of peripheral blood monocytes at the targeted trough VPA concentration in these patients
Determine the pharmacokinetic profile of this drug in these patients
Correlate histone acetylation with free or total trough VPA concentration in these patients
Determine preliminarily the antitumor activity of this drug in these patients
OUTLINE This is a dose-escalation multicenter study
For course 1 patients receive escalating doses of oral valproic acid VPA twice daily until a target serum trough VPA concentration range is maintained for 28 days Patients who achieve the target serum trough VPA concentration range receive subsequent courses of oral VPA twice daily at the dose found to maintain the target serum trough VPA concentration range on days 1-28 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
The first cohort of 6 patients receives VPA to achieve an initial target trough serum VPA concentration If fewer than 2 of 6 patients in the first cohort experience dose-limiting toxicity DLT then a second cohort of 6 patients receives VPA to achieve the next higher target trough serum VPA concentration If fewer than 2 patients from the second cohort experience DTL then 6 additional patients are enrolled in this cohort to better define pharmacokinetics and DLT at this VPA concentration range
After completion of study treatment patients are followed annually
PROJECTED ACCRUAL A total of 12-18 patients will be accrued for this study
Primary
Determine the toxic effects of valproic acid VPA administered at doses required to maintain serum trough VPA concentrations of 100-150 mcgmL or 150-200 mcgmL in young patients with recurrent or refractory solid tumors or CNS tumors
Secondary
Determine the steady-state serum trough concentration of free and total VPA at the targeted total trough VPA concentration in these patients
Determine the steady state histone acetylation status of peripheral blood monocytes at the targeted trough VPA concentration in these patients
Determine the pharmacokinetic profile of this drug in these patients
Correlate histone acetylation with free or total trough VPA concentration in these patients
Determine preliminarily the antitumor activity of this drug in these patients
OUTLINE This is a dose-escalation multicenter study
For course 1 patients receive escalating doses of oral valproic acid VPA twice daily until a target serum trough VPA concentration range is maintained for 28 days Patients who achieve the target serum trough VPA concentration range receive subsequent courses of oral VPA twice daily at the dose found to maintain the target serum trough VPA concentration range on days 1-28 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
The first cohort of 6 patients receives VPA to achieve an initial target trough serum VPA concentration If fewer than 2 of 6 patients in the first cohort experience dose-limiting toxicity DLT then a second cohort of 6 patients receives VPA to achieve the next higher target trough serum VPA concentration If fewer than 2 patients from the second cohort experience DTL then 6 additional patients are enrolled in this cohort to better define pharmacokinetics and DLT at this VPA concentration range
After completion of study treatment patients are followed annually
PROJECTED ACCRUAL A total of 12-18 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 |
|---|---|---|---|
| CDR0000417845 | OTHER | Clinical Trialsgov | None |
| COG-ADVL0419 | OTHER | None | None |
| NCI-05-C-0235 | None | None | None |
| NCI-P6631 | None | None | None |