Trial of Curcumin in Cutaneous T-cell Lymphoma Patients

NCT00969085 | Withdrawn Phase 2

• 1 other identifier: 2007-0838
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cutaneous T-cell Lymphoma

Keywords

Cutaneous T-cell lymphoma; Skin; Mycosis fungoides; MF; Sézary syndrome; SS; Curcumin; Turmeric

Outcome Measures

Primary Outcomes (1)

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

  Assessed every 4 weeks

Study Arms (1)

Curcumin

EXPERIMENTAL

Drug: Curcumin (Turmeric); Behavioral: Questionnaires; Other: Photos

Interventions

Curcumin (Turmeric) DRUG

Chew then swallow 2 sticks per day for up to 6 months. 2 sticks = 1 packet of curcumin = 8 grams

Also known as: Turmeric

Curcumin

Questionnaires BEHAVIORAL

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

Also known as: Surveys

Curcumin

Photos OTHER

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.

Also known as: Pictures

Curcumin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides; Sezary Syndrome

Interventions

Curcumin; Surveys and Questionnaires; Motion Pictures

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture

Study Officials

• Madeleine Duvic, MD

  UT MD Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2009
• First Posted: August 31, 2009
• Study Start: November 1, 2012
• Primary Completion: November 1, 2014
• Last Updated: September 7, 2012

Record last verified: 2012-09