Green Tea Extract in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia

NCT ID: NCT00262743

Last Updated: 2013-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2012-08-31

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 see how well it works in treating patients with stage 0, stage I, or stage II chronic lymphocytic leukemia (CLL).

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.

Conditions

Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

polyphenon E

Designed to assess toxicity, treatment response, and pertinent laboratory measurements in patients with previously untreated, asymptomatic, Rai Stage 0-II CLL.

Group Type: EXPERIMENTAL

Polyphenon E

Intervention Type: BIOLOGICAL

Phase I Dose Escalation:. 400 mg orally twice a day to 2000 mg orally twice a day

Phase II: 2000 mg orally twice a day

Interventions

Polyphenon E

Phase I Dose Escalation:. 400 mg orally twice a day to 2000 mg orally twice a day

Phase II: 2000 mg orally twice a day

Intervention Type: BIOLOGICAL

Eligibility Criteria

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tait D. Shanafelt, MD

Role: STUDY_CHAIR

Mayo Clinic

Jose F Leis, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

Shanafelt TD, Call TG, Zent CS, LaPlant B, Bowen DA, Roos M, Secreto CR, Ghosh AK, Kabat BF, Lee MJ, Yang CS, Jelinek DF, Erlichman C, Kay NE. Phase I trial of daily oral Polyphenon E in patients with asymptomatic Rai stage 0 to II chronic lymphocytic leukemia. J Clin Oncol. 2009 Aug 10;27(23):3808-14. doi: 10.1200/JCO.2008.21.1284. Epub 2009 May 26.

Reference Type: RESULT

PMID: 19470922 (View on PubMed)

Shanafelt TD, Call TG, Zent CS, Leis JF, LaPlant B, Bowen DA, Roos M, Laumann K, Ghosh AK, Lesnick C, Lee MJ, Yang CS, Jelinek DF, Erlichman C, Kay NE. Phase 2 trial of daily, oral Polyphenon E in patients with asymptomatic, Rai stage 0 to II chronic lymphocytic leukemia. Cancer. 2013 Jan 15;119(2):363-70. doi: 10.1002/cncr.27719. Epub 2012 Jul 3.

Reference Type: RESULT

PMID: 22760587 (View on PubMed)

Other Identifiers

P30CA015083

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1155-05

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2009-01227

Identifier Type: REGISTRY

Identifier Source: secondary_id

MC0419

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000454773

Identifier Type: -

Identifier Source: org_study_id

NCT00166335

Identifier Type: -

Identifier Source: nct_alias