Status:
COMPLETED
Green Tea Extract in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 se...
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-li...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00262743
Start Date
August 1 2005
End Date
August 1 2012
Last Update
May 30 2013
Active Locations (2)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
2
Mayo Clinic
Rochester, Minnesota, United States, 55905