RATIONALE: Green tea extract contains ingredients that may slow the growth of certain cancers, as well as prevent the development of new cancers.

PURPOSE: Phase I trial to study the effectiveness of green tea extract in treating patients with advanced solid tumors that are refractory to standard therapy.

Condition	Treatment or Intervention	Phase
unspecified adult solid tumor, protocol specific	Drug: green tea extract	Phase I

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

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

--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 radiation therapy and recovered
• Surgery: Not specified

--Patient Characteristics--

• Age: 18 and over
• Performance status: Zubrod 0-2 OR Karnofsky 70-100%
• Life expectancy: Not specified
• Hematopoietic: WBC greater than 4000/mm3; Platelet count greater than 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

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

Vincent A. Miller,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000066033; MSKCC-97128; NCI-G98-1375
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003197
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08