MDACC Study Summary ID01-155

Study Summary
No. ID01-155:.......Head and Neck; CTRC (Translational Research)......Vali Papadimitrakopoulou......Thoracic and Head and Neck Medical Oncology

Study Summary Title



Study Summary Number:	ID01-155

Study Title:	A PHASE II RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING PILOT STUDY OF ORALLY ADMINISTERED GREEN TEA EXTRACT FOR THE CHEMOPREVENTION OF MALIGNANT PROGRESSION OF ORAL PREMALIGNANT LESIONS IN HIGH RISK PATIENTS

Physician

New Patient Referral



Name:	Vali Papadimitrakopoulou	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Thoracic and Head and Neck Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6363 Contact us about clinical trials

General Information



Disease Group:	Head and Neck CTRC (Translational Research)	Supported By:	Ilex Oncology, Inc.

Phase of Study:	Phase II	Return Visit:	EVERY 4 WEEKS DURING ACTIVE INTERVENTION, AT WEEK 24, AND AT ONE YEAR

Treatment Agents:	Green Tea	Home Care:	N/A

Treatment Loc:	outpatient

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	Unavailable

Study Objectives / Outcomes

Unavailable

Study Status Information



Study Activation / Registration Date:	10/14/2002

IRB Review and Approval Date:	06/20/2001

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	41

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

ALL PATIENTS MUST HAVE ONE OR MORE HIGH RISK, ORAL, PREMALIGNANT LESIONS.

MALES OR FEMALES 18 TO 75 YEARS OF AGE.

PERFORMANCE STATUS OF <2 ON THE ZUBROD PERFORMANCE SCALE.

PATIENTS MUST HAVE AN ESTIMATED LIFE EXPECTANCY OF AT LEAST 12 WEEKS.

MEN AND WOMEN OF REPRODUCTIVE POTENTIAL MUST USE AN EFFECTIVE CONTRACEPTIVE METHOD WHILE ENROLLED IN THE STUDY.

PATIENTS MUST HAVE AN ABSOLUTE NEUTROPHIL COUNT >/= 1.5 X 10 9/L

PATIENTS MUST HAVE A PLATELETS COUNT OF >/= 100 X 10 9L.

PATIENTS MUST HAVE A HEMOGLOBIN OF =/>9 mg/dL.

PATIENTS MUST HAVE A SERUM CREATININE <2.0 mg/dL.

PATIENTS MUST HAVE A SERUM BILIRUBIN <2.0 mg/dL and an AST of <3 x INSTITUTIONAL ULN.

NO CONCURRENT CHEMOTHERAPY OR RADIOTHERAPY IS ALLOWED.

Females able to have children must have negative serum pregnancy test within 7 days prior to the first dose of medication.

Patients must be willing to provide written informed consent for participation.

No clinically significantly ECG abnormality; no history of unstable atrial or ventricular arrhythmias that require control by medication; no ischemic event experienced within the previous 6 months.

All patients must have bidimensionally measurable disease or high risk oral premaligant lesion (s) with 1 or more lesions amenable to biopsy.

Exclusion Criteria:

PATIENTS WITH A KNOWN HYPERSENSITIVITY TO STUDY DRUG OR ITS ANALOGS WILL NOT BE ELIGIBLE.

PATIENTS WHO HAVE USED INVESTIGATIONAL AGENTS INCLUDING EHCMOPREVENTION AGENTS WITH 30 DAYS OF STUDY WILL NOT BE ELIGIBLE.

PATIENTS WITH ANY SERIOUS INTERCURRENT ILLNESS, INCLUDING ACTIVE AND UNCONTROLLED INFECTION WILL NOT BE ELIGIBLE.

PATIENTS WITH EVIDENCE OF EXTRAORAL MALIGNANT DISEASE WILL NOT BE ELIGIBLE.

PATIENTS WITH ANY CONCURRENT CHEMOTHERAPY OR RADIOTHERAPY WILL NOT BE ELIGIBLE.

PATIENTS WITH PSYCHIATRIC DISORDERS THAT WOULD INTERFERE WITH CONSENT OR FOLLOW UP ARE NOT ELIGIBLE.

PATIENTS WITH A HISTORY OF PRIOR MALIGNANCY WITH LESS THAN ONE YEAR DISEASE-FREE INTERVAL PRIOR TO STUDY ENTRY ARE NOT ELIGIBLE.

PREGNANT OR LACTATING FEMALES ARE NOT ELIGIBLE.

PATIENTS WHO ARE NOT ABLE TO ABSTAIN FROM THE CONSUMPTION OF METHYLXANTHINE-CONTAINING PRODUCTS AND DECAFFEINATED TEA ARE NOT ELIGIBLE.

Any other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study, including caffeine intolerance or have medical conditions that could be aggravated by caffeine.

Links

Registration Number: