Trial of Curcumin in Cutaneous T-cell Lymphoma Patients

Cutaneous T-cell Lymphoma Clinical Trial

Official title: Phase II Trial of Curcumin in Cutaneous T-cell Lymphoma Patients

Status Withdrawn

Clinical Trial Summary

The goal of this clinical research study is to learn if treatment with curcumin can help to decrease the size of lesions and/or decrease itching in patients with MF or SS. The safety of curcumin will also be studied.

Clinical Trial 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 lesion(s). 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, and/or 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 lesion(s) will be taken.

• You will complete the 2 quality-of-life questionnaires.

• You will have a CT and/or 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 and/or 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cutaneous T-cell Lymphoma
• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous

• NCT number: NCT00969085
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Withdrawn
• Phase: Phase 2
• Start date: November 2012