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Trial of Curcumin in Cutaneous T-cell Lymphoma Patients

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00969085
First received: August 27, 2009
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Cutaneous T-cell Lymphoma
Drug: Curcumin (Turmeric)
Behavioral: Questionnaires
Other: Photos
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Curcumin in Cutaneous T-cell Lymphoma Patients

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Response Rate using Physician's Global Assessment (PGA) based on Severity-Weighted Assessment Tool (SWAT) [ Time Frame: Assessed every 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: November 2012
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Curcumin Drug: Curcumin (Turmeric)

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

2 sticks = 1 packet of curcumin = 8 grams

Other Name: Turmeric
Behavioral: Questionnaires
Quality of life (QOL) questionnaires completed on Day 1, Weeks 2, 4, 8, 12, 16, 20, and at end of treatment visit.
Other Name: Surveys
Other: Photos
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.
Other Name: Pictures

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. The patient has a Karnofsky Performance Status of more than or equal to 60 at study entry.
  4. The patient has given signed informed consent.
  5. The patient has a life expectancy greater than 6 months.
  6. 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.
  7. 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.
  8. 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.
  9. The patient is able to swallow curcumin powder.
  10. The patient must also agree to refrain from use of additional herbal supplements.
  11. There is no age limit for this protocol. Minor children will need to give assent with informed consent.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. The patient is pregnant (confirmed by serum beta-HCG) or is breast feeding.
  5. 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.
  6. 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.
  7. The patient has known HIV, active hepatitis B, and/or hepatitis C infection.
  8. 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.
  9. The patient has known allergies to any component of the study drug.
  10. The patient has any circumstances at the time of enrollment that would preclude completion of the study or the required follow-up.
  11. 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.
  12. The patient has biliary obstruction and/or elevated (greater than 2.5X normal) liver function studies (AST, ALT, and total bilirubin).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00969085

Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Madeleine Duvic, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00969085     History of Changes
Other Study ID Numbers: 2007-0838
Study First Received: August 27, 2009
Last Updated: September 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Cutaneous T-cell lymphoma
Skin
Mycosis fungoides
MF
Sézary syndrome
SS
Curcumin
Turmeric

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Curcumin
Turmeric extract
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antineoplastic Agents
Antioxidants
Antirheumatic Agents
Central Nervous System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014