RATIONALE: Green tea extract contains ingredients that may inhibit the growth of actinic keratosis. PURPOSE: Randomized phase II trial to determine the effectiveness of green tea extract in treating patients who have actinic keratosis.

Condition	Treatment or Intervention	Phase
actinic keratosis squamous cell carcinoma of the skin prevention of skin cancer basal cell carcinoma of the skin	Drug: green tea extract	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the efficacy of the green tea extract epigallocatechin gallate (Polyphenon E topical ointment) in causing complete clinical and histopathologic regression in patients with actinic keratoses. II. Determine duration of treatment with Polyphenon E necessary to cause regression in these patients. III. Describe pathophysiologic and molecular alterations in actinic keratoses and sun damaged skin that are not present in skin that is not sun damaged in these patients. IV. Determine the effects of this treatment on biomarkers for skin cancer in these patients.

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. One of the patient's arms is randomized to receive topical epigallocatechin gallate (Polyphenon E), the other arm to receive a placebo. Patients receive topical applications daily for 12 weeks, or until resolution of all actinic keratoses within the treatment field.

PROJECTED ACCRUAL: A minimum of 60 patients will be accrued for this study over 10 months.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Clinically and histologically confirmed grade 1-3 actinic keratoses; At least 2 actinic keratoses on each arm

--Prior/Concurrent Therapy--

• Biologic therapy: At least 2 months since prior immunotherapy
• Chemotherapy: At least 2 months since prior topical application of fluorouracil or masoprocol for actinic keratoses; At least 2 months since prior systemic chemotherapy; No further anticipated chemotherapy
• Endocrine therapy: At least 2 weeks since prior topical corticosteroids to target lesions; At least 4 weeks since prior systemic steroid therapy
• Radiotherapy: No anticipated radiotherapy
• Surgery: Not specified
• Other: At least 2 weeks since prior other topical medications (e.g., retinoids or alpha hydroxyacids such as glycolic acid or lactic acid); At least 2 months since prior cryotherapy to target lesions; At least 2 months since prior systemic psoralens or retinoids; At least 2 months since prior laser resurfacing or chemical peels; At least 30 days since prior other investigational drug; No other concurrent topical medication to areas being studied

--Patient Characteristics--

• Age: Over 18
• Performance status: SWOG 0-1; Karnofsky 70-100%
• Life expectancy: Not specified
• Hematopoietic: Not specified
• Hepatic: Not specified
• Renal: Not specified
• Other: No prior invasive malignancy within past 5 years except nonmelanomatous skin cancer, stage I carcinoma in situ of the cervix, or stage 0 chronic lymphocytic leukemia; No severe metabolic disorder; No life threatening acute or chronic disease; No medical condition that would preclude study; No active systemic infectious disease that may affect immune system; No prior keloid formation; Not pregnant or nursing; Negative pregnancy test

California
      Chao Family Comprehensive Cancer Center, Orange,  California,  92868,  United States

Study chairs or principal investigators

Frank L. Meyskens, Jr.,  Study Chair,  Chao Family Comprehensive Cancer Center   

Study ID Numbers:  CDR0000067798; UCIRVINE-N01-CN-85182; NCI-P00-0142
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  April 6, 2000
ClinicalTrials.gov Identifier:  NCT00005097
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08