Full Text View
Tabular View
No Study Results Posted
Related Studies
Green Tea Extract in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), January 2009
First Received: December 6, 2005   Last Updated: April 14, 2009   History of Changes
Sponsors and Collaborators: Mayo Clinic
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00262743
  Purpose

RATIONALE: Green tea extract contains ingredients that may slow the growth of certain cancers.

PURPOSE: This phase I/II trial is studying the side effects and best dose of green tea extract and to see how well it works in treating patients with stage 0, stage I, or stage II chronic lymphocytic leukemia.


Condition Intervention Phase
Leukemia
Dietary Supplement: defined green tea catechin extract
Phase I
Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic
Drug Information available for: Catechin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I/II Study of Daily Oral Polyphenon E in Asymptomatic, Rai Stage 0-II Patients With Chronic Lymphocytic Leukemia

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Dose-limiting toxicity as measured by CTCAE [ Designated as safety issue: Yes ]
  • Confirmed response defined as objective status of complete response (CR), complete clinical response (CCR), nodular partial response (NPR), and partial response (PR) on 2 consecutive evaluations at least 4 weeks apart [ Designated as safety issue: No ]
  • Biological response on 2 consecutive evaluations at least 4 weeks apart [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical response (CR, CCR, NPR, and PR) at least 4 weeks apart [ Designated as safety issue: No ]

Estimated Enrollment: 73
Study Start Date: August 2005
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Phase I

  • Determine the maximally tolerated dose of green tea extract (Polyphenon E) in patients with previously untreated stage 0-II chronic lymphocytic leukemia.
  • Describe the dose-limiting toxicity of green tea extract (Polyphenon E).

Phase II

  • Evaluate the response rate and response duration of patients with previously untreated, asymptomatic Rai stage 0-II chronic lymphocytic leukemia treated with green tea extract (Polyphenon E) for 6 months at the MTD.
  • Further characterize toxicity.

OUTLINE: This is a phase I, dose-escalation study of green tea extract (Polyphenon E) followed by a phase II study.

  • Phase I: Patients receive oral green tea extract (Polyphenon E) once or twice daily for 4 weeks. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of green tea extract (Polyphenon E) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
  • Phase II: Patients receive green tea extract (Polyphenon E) as in the phase I portion of the study at the MTD.

After completion of study treatment, patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: A total of 73 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Confirmed diagnosis of chronic lymphocytic leukemia (CLL)

    • Stage 0, I, or II disease
    • Previously untreated disease
    • Splenomegaly, hepatomegaly, or lymphadenopathy are not required for the diagnosis of CLL
    • Absolute lymphocyte count > 10,000/mm^3
    • Lymphocytosis must consist of small to moderate size lymphocytes, with ≤ 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically
    • Phenotypically characterized B-CLL defined by all of the following criteria:

      • A population of leukemic cells that co-expresses the B-cell antigen CD23 as well as CD5 in the absence of other T-cell markers (CD3, CD2, etc.)
      • Dim surface immunoglobulin expression
      • Exclusively κ or λ light chains
    • Mantle cell lymphoma must be excluded by demonstrating the absence of the t(11:14) by FISH testing
  • Patients who require chemotherapy for treatment of CLL, based on any of the following criteria, are excluded:

    • CLL-related symptoms requiring treatment, including any of the following:

      • Unintentional weight loss ≥ 10% body weight within the previous 6 months
      • Extreme fatigue
      • Fevers > 100.5°F for 2 weeks without evidence of infection
      • Night sweats without evidence of infection
    • Evidence of progressive marrow failure due to CLL involvement of bone marrow as manifested by the development of worsening anemia (hemoglobin < 11 g/dl) and/or thrombocytopenia (platelet count < 100,000/mm^3)

      • Thrombocytopenia due to immune phenomena (ITP) is permitted as long as platelet count is ≥ 100,000/mm^3and the patient is not on active pharmacologic therapy
    • Massive (i.e. > 6 cm below left costal margin) or progressive splenomegaly
    • Massive nodes or clusters (i.e., > 10 cm in longest diameter) or progressive adenopathy
    • Progressive lymphocytosis with an increase of > 50% over 2 month period, or an anticipated lymphocyte doubling time of < 6 months

PATIENT CHARACTERISTICS:

  • Platelet count ≥ 100,000/µL
  • ANC ≥ 1500/µL
  • Hemoglobin ≥ 11 g/dL
  • Total or direct bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • AST (SGOT) and ALT (SGPT) ≤ 2 x ULN
  • Creatinine ≤ 1.5 x ULN OR creatinine clearance ≥ 40 mL/min
  • May have a history of autoimmune hemolytic anemia (AIHA) and positive Coombs test provided there has not been active hemolysis requiring transfusion or steroid treatment ≤ 10 weeks prior to registration
  • ECOG performance status 0, 1, or 2
  • Life expectancy of ≥ 6 months
  • No uncontrolled infection
  • No myocardial infarction within the past 6 weeks
  • No New York Heart Association class III or IV congestive heart failure
  • Not pregnant or nursing
  • Negative pregnancy test
  • Must employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], or abstinence, etc.) prior to study entry and for the duration of study participation
  • No other severe medical or psychiatric illness
  • No active hemolysis requiring transfusion or other pharmacologic therapy

PRIOR CONCURRENT THERAPY:

  • At least 8 weeks since prior and no other concurrent over the counter green tea or green tea extract
  • No prior daily use of over the counter green tea products for medicinal purposes for > 4 weeks (phase II only)
  • No other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation)
  • No concurrent combination anti-retroviral therapy for HIV positive patients
  • No concurrent oral steroid preparations
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262743

Locations
United States, Minnesota
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Tait D. Shanafelt, MD Mayo Clinic
Investigator: Neil E. Kay, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Roswell Park Cancer Institute ( Alex A. Adjei )
Study ID Numbers: CDR0000454773, MAYO-MC0419, NCI-7303, CLLT-MAYO-MC0419
Study First Received: December 6, 2005
Last Updated: April 14, 2009
ClinicalTrials.gov Identifier: NCT00262743     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
B-cell chronic lymphocytic leukemia
stage 0 chronic lymphocytic leukemia
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia

Study placed in the following topic categories:
Epigallocatechin gallate
Lymphatic Diseases
Leukemia
Chronic Lymphocytic Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-cell, Chronic
Lymphoproliferative Disorders
Leukemia, B-Cell

Additional relevant MeSH terms:
Lymphatic Diseases
Leukemia
Neoplasms
Leukemia, Lymphoid
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoproliferative Disorders
Leukemia, B-Cell

ClinicalTrials.gov processed this record on May 07, 2009