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A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of Polyphenon E Against Various Endpoints of Actinic Keratosis Pathobiology


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-melanomatous Skin Cancer

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Trial Information

A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of Polyphenon E Against Various Endpoints of Actinic Keratosis Pathobiology


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.

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.

Inclusion Criteria


DISEASE CHARACTERISTICS: Clinically and histologically confirmed grade 1-3 actinic
keratoses At least 2 actinic keratoses on each arm

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

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Clinical and histopathologic regression of actinic keratoses

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Frank L. Meyskens, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Chao Family Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067798

NCT ID:

NCT00005097

Start Date:

March 2000

Completion Date:

Related Keywords:

  • Non-melanomatous Skin Cancer
  • squamous cell carcinoma of the skin
  • Skin Neoplasms
  • Keratosis
  • Keratosis, Actinic

Name

Location

Chao Family Comprehensive Cancer CenterOrange, California  92868