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Cutaneous T-cell LymphomaPhase 2NCT00969085

Trial of Curcumin in Cutaneous T-cell Lymphoma Patients

A Phase 2 study testing Curcumin (Turmeric), Questionnaires and Photos in people with Cutaneous T-cell Lymphoma, run by M.D. Anderson Cancer Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Cutaneous T-cell Lymphoma
What is being tested?
Curcumin (Turmeric), Questionnaires and Photos
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Nov 2012to Nov 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • The patient has pathologically confirmed mycosis fungoides (MF) or Sézary syndrome (SS) form of cutaneous T-cell lymphoma (CTCL). Histology must be confirmed by the pathology department of the investigational center. This study is opened to MF and SS patients Stages 1A-IVA except for patients with aggressive disease requiring systemic chemotherapy. The patient must have pruritus at a severity of at least 3 to be eligible for the protocol.
  • The patient has been on a stable dose of antihistamine for at least two weeks and promises not to change the antihistamine or increase the dose.
  • The patient has a Karnofsky Performance Status of more than or equal to 60 at study entry.
  • The patient has given signed informed consent.
  • The patient has a life expectancy greater than 6 months.
  • The patient has adequate hematologic function as defined by an absolute neutrophil count more than or equal to 1,500/mm^3, platelet count more than or equal to 100,000/mm^3.
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  • The patient has adequate hepatic and renal function as defined by a total bilirubin less than or equal to 2.0 X ULN, alkaline phosphatase, AST and ALT less than or equal to 2.5 X ULN, and creatinine less than or equal to 2.0 mg/dL.
  • The patient agrees to practice effective contraception during the entire study period unless documentation of infertility exists. The methods of contraception include: abstinence, hormonal contraception (pills, injections, implants, and patches), intrauterine device, barrier methods (diaphragms, cervical caps, sponges, male and female condoms), and sterilization (vasectomy or tubal ligation). Women of childbearing potential are women who have not been menopausal for 12 consecutive months or have never been previously sterilized.
  • The patient is able to swallow curcumin powder.
  • The patient must also agree to refrain from use of additional herbal supplements.
  • There is no age limit for this protocol. Minor children will need to give assent with informed consent.

Who cannot join

  • The patient has a history of treated or active brain metastases, carcinomatous meningitis, an uncontrolled seizure disorder, or active neurological disease or has visceral disease stage IVB.
  • The patient has received prior local radiation treatment that would preclude evaluation for efficacy, or has received total body skin electron beam within 3 months prior to starting the trial.
  • The patient has an unstable medical condition according to the investigator, including, but are not limited to, an aggressive disease requiring systemic chemotherapy, uncontrolled diabetes mellitus Hgb A1c : >/= 8.or hypertension ( BP >/=140/90) or in the doctors opinion, active infections requiring systemic antibiotics, antivirals, or antifungals, unstable congestive heart failure, uncontrolled arrhythmias, unstable angina pectoris, unstable coagulation disorders, or psychiatric illness/social situations that would limit compliance with study requirements.
  • The patient is pregnant (confirmed by serum beta-HCG) or is breast feeding.
  • The patient is on any systemic therapy for MF/SS within the past 4 weeks, with the exception of Sézary syndrome patients, who may continue up to 10 mg of prednisone throughout trial participation.
  • The patient is on any topical therapy within the past 2 weeks, except if he/she has been using a stable dosage of topical steroids which does not exceed 2.5% hydrocortisone in MF patients, or triamcinolone 0.1% in Sézary syndrome patients. The patient must have been off high-potency steroids for at least 2 weeks. Moisturizers are allowed if they are not medicated and have been used for at least 2 weeks prior.
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  • The patient has known HIV, active hepatitis B, and/or hepatitis C infection.
  • The patient currently has an active cancer other than CTCL that was diagnosed or had recurred in the last 2 years. The patient is allowed to participate if he/she has a history of skin cancers that have been treated.
  • The patient has known allergies to any component of the study drug.
  • The patient has any circumstances at the time of enrollment that would preclude completion of the study or the required follow-up.
  • The patient currently on active anticoagulation therapy (warfarin, aspirin, aspirin-containing products, NSAIDS or antiplatelet agents (eg, ticlopidine, clopidogrel, dipyridamole) who are at risk for platelet suppression.
  • The patient has biliary obstruction and/or elevated (greater than 2.5X normal) liver function studies (AST, ALT, and total bilirubin).

About this study

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

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.

Read the 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 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.

Being tested
Curcumin (Turmeric), Questionnaires, Photos
Keywords
Cutaneous T-cell lymphoma, Skin, Mycosis fungoides, MF, Sézary syndrome, SS, Curcumin, Turmeric
Medical subject headings
Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Curcumin (Turmeric)Drug

    Also called Turmeric

    Chew then swallow 2 sticks per day for up to 6 months.

    2 sticks = 1 packet of curcumin = 8 grams

  • QuestionnairesBehavioural

    Also called Surveys

    Quality of life (QOL) questionnaires completed on Day 1, Weeks 2, 4, 8, 12, 16, 20, and at end of treatment visit.

  • PhotosOther

    Also called Pictures

    Photos of up to 6 selected skin lesion(s) and half-body photos taken on Day 1, Weeks 2, 4, 12, and at end of treatment visit.

Study groups in NCT00969085
Study groupRoleWhat they receive
CurcuminExperimentalNot described
Receives: Drug: Curcumin (Turmeric); Behavioral: Questionnaires; Other: Photos

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response Rate using Physician's Global Assessment (PGA) based on Severity-Weighted Assessment Tool (SWAT)

    Measured: Assessed every 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2009 (estimated)
  2. Study startNov 2012
  3. Primary completionNov 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00969085
Sponsor's protocol ID
2007-0838
Status last verified
Sep 2012
First submitted
27 Aug 2009
Last updated
7 Sep 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Curcumin (Turmeric), Questionnaires and Photos in people with Cutaneous T-cell Lymphoma, run by M.D. Anderson Cancer Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 7 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response Rate using Physician's Global Assessment (PGA) based on Severity-Weighted Assessment Tool (SWAT) (time frame: Assessed every 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00969085.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2012.

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