Ignite Creation Date:
2024-05-05 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00496444
Status:
COMPLETED
Last Update Posted:
2012-08-01
First Post:
2007-07-02
Brief Title:
Azacytidine and Valproic Acid in Patients With Advanced Cancers
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase I Study of Low-Dose Hypomethylating Agent Azacitidine Combined With the Histone Deacetylase Inhibitor Valproic Acid in Patients With Advanced Cancers
Status:
COMPLETED
Status Verified Date:
2012-07
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:
Primary Objective
1 To evaluate side effects and maximum tolerated dose of azacitidine and valproic acid in patients with advanced cancer
Secondary Objectives
1 To perform a preliminary assessment of the histone acetylation and DNA methylation effects of this combination on peripheral blood mononuclear cells PBMC
2 To assess the clinical anti-tumor activity objective response including complete and partial responses of this combination in patients with advanced cancer in a descriptive fashion
1 To evaluate side effects and maximum tolerated dose of azacitidine and valproic acid in patients with advanced cancer
Secondary Objectives
1 To perform a preliminary assessment of the histone acetylation and DNA methylation effects of this combination on peripheral blood mononuclear cells PBMC
2 To assess the clinical anti-tumor activity objective response including complete and partial responses of this combination in patients with advanced cancer in a descriptive fashion
Detailed Description:
Azacitidine is a new chemotherapy drug that is designed to destroy cancer cells at high doses At low doses it is designed to destroy some cancer cells as well as cause changes that may make cancer cells less harmful Valproic acid is a drug that is used in every day practice in the treatment of seizures migraine headache and mood disturbance in bipolar disorders
Before you can start receiving the study drug you will have what are called screening tests These tests will help the doctor decide if you are eligible to take part in the study You will have a complete physical exam including routine blood tests about 4 teaspoons You may have to get either a CT scan or a MRI to measure your disease if you have not had one within 1 month Women who are able to have children must have a negative blood-pregnancy test
If you are found to be eligible to take part in this study you will receive the study drug in cycles Cycles will generally be 4 weeks long but may be longer depending on any side effects you experience from the azacitidine During each cycle you will receive azacitidine under the skin once each day for the first 10 days Day 1 to Day 10 You will then have an 18-day break during which you will not receive azacitidine injections for the rest of the cycle Additionally you will take valproic acid pills by mouth every day starting the first day of the first cycle Day 1 to Day 28 You will take valproic acid every day while on study without interruption
The dose of azacitidine that you receive will depend on when you enroll in this study You will be part of a study group cohort 6 patients will be enrolled in each cohort All members of a cohort receive the same dose of azacitidine when they begin receiving the study drug Each new cohort will receive a higher dose than the cohort before The dose of azacitidine that you receive may be adjusted depending on how well you tolerate it The starting dose of valproic acid is fixed for all the patients but this dose may be adjusted by your physician based on the results of your blood work
You will have a physical exam and blood tests about 1 tablespoon each every two weeks of the first two study drug cycles For further cycles you will have a physical exam and blood test only once a month Your disease will be measured by CT scan or MRI after every 2 treatment cycles
You may continue to receive the study drug on this study until your disease gets worse or intolerable side effects occur After your participation in this study is over you will receive follow-up care as is standard of care for your disease
This is an investigational study The FDA has approved azacitidine for a blood disease known as myelodysplastic syndrome Its use in this study is experimental The valproic acid is a drug approved by the FDA for treatment of seizure bipolar disorders and migraine headaches Up to 68 patients will take part in the study All will be enrolled at M D Anderson
Before you can start receiving the study drug you will have what are called screening tests These tests will help the doctor decide if you are eligible to take part in the study You will have a complete physical exam including routine blood tests about 4 teaspoons You may have to get either a CT scan or a MRI to measure your disease if you have not had one within 1 month Women who are able to have children must have a negative blood-pregnancy test
If you are found to be eligible to take part in this study you will receive the study drug in cycles Cycles will generally be 4 weeks long but may be longer depending on any side effects you experience from the azacitidine During each cycle you will receive azacitidine under the skin once each day for the first 10 days Day 1 to Day 10 You will then have an 18-day break during which you will not receive azacitidine injections for the rest of the cycle Additionally you will take valproic acid pills by mouth every day starting the first day of the first cycle Day 1 to Day 28 You will take valproic acid every day while on study without interruption
The dose of azacitidine that you receive will depend on when you enroll in this study You will be part of a study group cohort 6 patients will be enrolled in each cohort All members of a cohort receive the same dose of azacitidine when they begin receiving the study drug Each new cohort will receive a higher dose than the cohort before The dose of azacitidine that you receive may be adjusted depending on how well you tolerate it The starting dose of valproic acid is fixed for all the patients but this dose may be adjusted by your physician based on the results of your blood work
You will have a physical exam and blood tests about 1 tablespoon each every two weeks of the first two study drug cycles For further cycles you will have a physical exam and blood test only once a month Your disease will be measured by CT scan or MRI after every 2 treatment cycles
You may continue to receive the study drug on this study until your disease gets worse or intolerable side effects occur After your participation in this study is over you will receive follow-up care as is standard of care for your disease
This is an investigational study The FDA has approved azacitidine for a blood disease known as myelodysplastic syndrome Its use in this study is experimental The valproic acid is a drug approved by the FDA for treatment of seizure bipolar disorders and migraine headaches Up to 68 patients will take part in the study All will be enrolled at M D Anderson
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