NCT00003197

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 1997

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1997

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2000

Completed
4.2 years until next milestone

First Posted

Study publicly available on registry

August 12, 2004

Completed
Last Updated

June 26, 2013

Status Verified

June 1, 2013

Enrollment Period

2.5 years

First QC Date

November 1, 1999

Last Update Submit

June 24, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

green tea extractDIETARY_SUPPLEMENT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Interventions

Tea

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Vincent A. Miller, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 12, 2004

Study Start

December 1, 1997

Primary Completion

June 1, 2000

Study Completion

June 1, 2000

Last Updated

June 26, 2013

Record last verified: 2013-06

Locations

US(1)