Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00358319
Status:
TERMINATED
Last Update Posted:
2013-11-25
First Post:
2006-07-27
Brief Title:
Phase III Trial of Valproic Acid and Karenitecin for Melanoma
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Phase III Trial of Valproic Acid and Karenitecin for Metastatic Malignant Melanoma
Status:
TERMINATED
Status Verified Date:
2011-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left Moffitt
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase I study looking at the combination of Valproic Acid VPA and Karenitecin to treat patients with metastatic malignant melanoma We will find the dose-limiting toxicity DLT and the highest dose maximum tolerated dose of this combination treatment that has acceptable side effects and recommend a Phase II dose level
There will be seven escalating doses of Valproic acid and one dose escalation step of Karenitecin Each patient shall receive one cycle of Karenitecin alone cycle 1 days 1 - 5 followed by the same dose of Karenitecin given in combination with VPA cycle 2 days 1-7 Patients will receive oral VPA in divided doses for 5 days and Karenitecin starting on the 3rd day every 3 weeks a treatment cycle
Treatment will continue until progression of disease or an unacceptable level of toxicity After 2 cycles of treatment there will be the first efficacy evaluation or restaging of the disease In the absence of disease progression and if there is continued safety and tolerability treatment may continue
There will be seven escalating doses of Valproic acid and one dose escalation step of Karenitecin Each patient shall receive one cycle of Karenitecin alone cycle 1 days 1 - 5 followed by the same dose of Karenitecin given in combination with VPA cycle 2 days 1-7 Patients will receive oral VPA in divided doses for 5 days and Karenitecin starting on the 3rd day every 3 weeks a treatment cycle
Treatment will continue until progression of disease or an unacceptable level of toxicity After 2 cycles of treatment there will be the first efficacy evaluation or restaging of the disease In the absence of disease progression and if there is continued safety and tolerability treatment may continue
Detailed Description:
Treatment cycles are every 3 weeks and there are 17 study visits in all
During Phase I subjects will receive one cycle of Karenitecin alone cycle 1 days 1-5 and then combination therapy with VPA Karenitecin cycle 2 days 1-7followed by oral VPA in divided doses for 5 days and Karenitecin starting the third day days 3-7 every 3 weeks After 2 cycles of treatment there will be the first efficacy evaluation or restaging of the disease
Dose escalations will continue until unacceptable dose limiting toxicity DLT occurs then dose escalation will be stopped and the previous dose level will be explored In each dose level participants will undergo pharmacokinetic PK sampling to determine blood levels The melanoma skin lesions will also be biopsied to measure the effect of the combination therapy
All patients enrolled in the Phase II will be treated with VPA and Karenitecin using the dosing schedule determined to be the MTD in Phase I In the absence of disease progression and if there is continued safety and tolerability treatment may continue in consecutive 3 week cycles
During Phase I subjects will receive one cycle of Karenitecin alone cycle 1 days 1-5 and then combination therapy with VPA Karenitecin cycle 2 days 1-7followed by oral VPA in divided doses for 5 days and Karenitecin starting the third day days 3-7 every 3 weeks After 2 cycles of treatment there will be the first efficacy evaluation or restaging of the disease
Dose escalations will continue until unacceptable dose limiting toxicity DLT occurs then dose escalation will be stopped and the previous dose level will be explored In each dose level participants will undergo pharmacokinetic PK sampling to determine blood levels The melanoma skin lesions will also be biopsied to measure the effect of the combination therapy
All patients enrolled in the Phase II will be treated with VPA and Karenitecin using the dosing schedule determined to be the MTD in Phase I In the absence of disease progression and if there is continued safety and tolerability treatment may continue in consecutive 3 week cycles
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