Phase I Evaluation of Green Tea Extract in Adults With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Evaluation of Green Tea Extract in Adults With Advanced Solid Tumors


OBJECTIVES: I. Determine the maximum tolerated dose of green tea extract administered daily
to adults with solid tumors. II. Determine the safety of chronic daily administration of
green tea extract in these patients. III. Investigate the clinical pharmacology of green tea
extract in this study. IV. Document observed antitumor activity of this treatment.

OUTLINE: This is a dose escalation study of green tea extract. Patients receive green tea
extract by mouth daily after meals for 4 weeks. One patient is entered at each dose level.
If grade II toxicities are experienced, then 2 more patients are entered at the same dose
level. One patient must complete 4 weeks of therapy and 2 others must complete 2 weeks of
therapy with no greater than grade I toxicity before dose escalation proceeds. If at least 2
patients experience dose limiting toxicity at any dose level, the immediately preceding dose
level is considered the maximum tolerated dose (MTD). At least 6 patients are studied at the
MTD. Patients may continue therapy for up to 6 months in the absence of toxicity and disease
progression. Patients are followed every 4 weeks for the duration of treatment and at least
one month after completing treatment.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Pathologically proven incurable advanced solid tumor refractory
to standard therapy or for which no standard therapy exists No known brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 OR Karnofsky
70-100% Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm3 Platelet
count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST less than 1.25
times normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No significant
cardiac disease Other: No significant metabolic disorder No significant infection Not
pregnant or nursing Effective contraception must be used by fertile women

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks
(6 weeks for nitrosourea) since prior chemotherapy and recovered Endocrine therapy: Not
specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery:
Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Vincent A. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

97-128

NCT ID:

NCT00003197

Start Date:

December 1997

Completion Date:

June 2000

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021