Trial of Curcumin in Cutaneous T-cell Lymphoma Patients

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Curcumin; Turmeric extract

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).