Ignite Creation Date:
2024-05-05 @ 9:48 PM
Last Modification Date:
2024-10-26 @ 10:10 AM
Study NCT ID:
NCT00969085
Status:
WITHDRAWN
Last Update Posted:
2012-09-07
First Post:
2009-08-27
Brief Title:
Trial of Curcumin in Cutaneous T-cell Lymphoma Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Trial of Curcumin in Cutaneous T-cell Lymphoma Patients
Status:
WITHDRAWN
Status Verified Date:
2012-09
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:
The goal of this clinical research study is to learn if treatment with curcumin can help to decrease the size of lesions andor decrease itching in patients with MF or SS The safety of curcumin will also be studied
Detailed Description:
Curcumin
Curcumin a yellow substance taken from a plant is commonly used in cooking as a spice called turmeric In this study participants will receive much higher doses of curcumin than can be received through food
Curcumin may block proteins that help cells to divide These proteins also may stop cancer cells from dying
Study Drug Administration
If you are found to be eligible to take part in this study you will swallow 2 sticks of curcumin per day You should take the 2 sticks each morning with food and enough water for you to be able to swallow them If you miss taking a dose of curcumin in the morning you can take it later that day as soon as you remember However if you miss a dose all day do not take 2 doses the next day to make up for it
Study Visits
You will be asked to return for study visits
At baseline Day 1 the following tests and procedures will be performed
You will have a physical exam including measurement of your vital signs
You will be asked to rate your itching on a scale of 0-10
You will complete the 2 quality-of-life questionnaires
The study staff will take photos of up to 6 selected skin lesions These will be close-up photos of the lesions and a small area of surrounding skin Half-body photos will also be taken These will be front back andor side views of the top and bottom half of your body depending on where the lesions are For the half-body photos your private areas will be covered as much as possible and your face will not be included in the photos unless there are lesions there
Blood about 3 teaspoons will be drawn for routine tests
You will complete 2 quality-of-life questionnaires that ask how the symptoms of the disease may be affecting your life This should take about 5 minutes
You will have a physical exam including having skin lesions and affected areas of your skin looked at by the study doctor
If the study doctor thinks it is needed you will have a skin biopsy performed To perform a skin biopsy the area is numbed with anesthetic and a small amount of tissue about the size of a pencil eraser is removed with a special tool
The following tests and procedures will be performed at Weeks 2 4 8 12 16 and 20
You will have a physical exam including having skin lesions and affected areas of your skin looked at by the study doctor
You will complete the 2 quality-of-life questionnaires
Your vital signs will be measured
You will be asked to rate your itching on a scale of 0-10
At Weeks 2 4 and 12 only the following additional test will be performed
-Just like at baseline you will have skin lesion photos and half-body photos taken
At Weeks 4 12 and 20 only the following additional test will be performed
-Blood about 3 teaspoons will be drawn for routine tests
If the doctor decides it is needed based on abnormal blood tests at screening additional blood about 1 teaspoon will be drawn to check the status of the disease at Weeks 2 4 8 and 12
If at any time during the study the skin disease seems to have cleared you will have a skin biopsy performed in order to confirm the response
Length of Study Participation
You may continue receiving the study drug for up to 6 months as long as you and the study doctor think you are benefitting from taking curcumin If the disease gets worse or intolerable side effects occur at any time during this study you will be taken off study
End-of-Treatment Visit
When you go off study for any reason you will have an end-of-treatment visit The following procedures will be performed
You will have a physical exam
You will be asked to rate your itching on a scale of 0-10
Blood about 2 teaspoons will be drawn for routine tests
If the doctor decides it is needed based on abnormal blood tests at screening additional blood about 1 teaspoon will be drawn to check the status of the disease
A skin biopsy will be performed to check the status of the disease
Photos of the skin lesions will be taken
You will complete the 2 quality-of-life questionnaires
You will have a CT andor PET scan to check the size of the lymph nodes
Follow-Up
Every 3 months for 6 months after your last dose of the study drug the study staff will check the results of any routine tests that were performed at your regular follow-up visits for MF or SS If you do not visit the clinic during one or both of these two 3-month time periods you will be called at home at 3 months andor 6 months after your last dose of the study drug The purpose of the phone calls is to ask how you are doing
This is an investigational study Curcumin is not FDA approved or commercially available for the treatment of cutaneous T-cell lymphoma For this purpose it is being used in research only
Up to 20 patients will take part in this study All will be enrolled at M D Anderson
Curcumin a yellow substance taken from a plant is commonly used in cooking as a spice called turmeric In this study participants will receive much higher doses of curcumin than can be received through food
Curcumin may block proteins that help cells to divide These proteins also may stop cancer cells from dying
Study Drug Administration
If you are found to be eligible to take part in this study you will swallow 2 sticks of curcumin per day You should take the 2 sticks each morning with food and enough water for you to be able to swallow them If you miss taking a dose of curcumin in the morning you can take it later that day as soon as you remember However if you miss a dose all day do not take 2 doses the next day to make up for it
Study Visits
You will be asked to return for study visits
At baseline Day 1 the following tests and procedures will be performed
You will have a physical exam including measurement of your vital signs
You will be asked to rate your itching on a scale of 0-10
You will complete the 2 quality-of-life questionnaires
The study staff will take photos of up to 6 selected skin lesions These will be close-up photos of the lesions and a small area of surrounding skin Half-body photos will also be taken These will be front back andor side views of the top and bottom half of your body depending on where the lesions are For the half-body photos your private areas will be covered as much as possible and your face will not be included in the photos unless there are lesions there
Blood about 3 teaspoons will be drawn for routine tests
You will complete 2 quality-of-life questionnaires that ask how the symptoms of the disease may be affecting your life This should take about 5 minutes
You will have a physical exam including having skin lesions and affected areas of your skin looked at by the study doctor
If the study doctor thinks it is needed you will have a skin biopsy performed To perform a skin biopsy the area is numbed with anesthetic and a small amount of tissue about the size of a pencil eraser is removed with a special tool
The following tests and procedures will be performed at Weeks 2 4 8 12 16 and 20
You will have a physical exam including having skin lesions and affected areas of your skin looked at by the study doctor
You will complete the 2 quality-of-life questionnaires
Your vital signs will be measured
You will be asked to rate your itching on a scale of 0-10
At Weeks 2 4 and 12 only the following additional test will be performed
-Just like at baseline you will have skin lesion photos and half-body photos taken
At Weeks 4 12 and 20 only the following additional test will be performed
-Blood about 3 teaspoons will be drawn for routine tests
If the doctor decides it is needed based on abnormal blood tests at screening additional blood about 1 teaspoon will be drawn to check the status of the disease at Weeks 2 4 8 and 12
If at any time during the study the skin disease seems to have cleared you will have a skin biopsy performed in order to confirm the response
Length of Study Participation
You may continue receiving the study drug for up to 6 months as long as you and the study doctor think you are benefitting from taking curcumin If the disease gets worse or intolerable side effects occur at any time during this study you will be taken off study
End-of-Treatment Visit
When you go off study for any reason you will have an end-of-treatment visit The following procedures will be performed
You will have a physical exam
You will be asked to rate your itching on a scale of 0-10
Blood about 2 teaspoons will be drawn for routine tests
If the doctor decides it is needed based on abnormal blood tests at screening additional blood about 1 teaspoon will be drawn to check the status of the disease
A skin biopsy will be performed to check the status of the disease
Photos of the skin lesions will be taken
You will complete the 2 quality-of-life questionnaires
You will have a CT andor PET scan to check the size of the lymph nodes
Follow-Up
Every 3 months for 6 months after your last dose of the study drug the study staff will check the results of any routine tests that were performed at your regular follow-up visits for MF or SS If you do not visit the clinic during one or both of these two 3-month time periods you will be called at home at 3 months andor 6 months after your last dose of the study drug The purpose of the phone calls is to ask how you are doing
This is an investigational study Curcumin is not FDA approved or commercially available for the treatment of cutaneous T-cell lymphoma For this purpose it is being used in research only
Up to 20 patients will take part in this 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