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Azadirachta Indica in Treating Patients With Chronic Lymphocytic Leukemia

Sponsor
Roswell Park Cancer Institute (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01251250
Collaborator
(none)
0
Enrollment
1
Arm

Study Details

Study Description

Brief Summary

RATIONALE: Azadirachta indica may be an effective treatment for chronic lymphocytic leukemia. PURPOSE: This phase I trial is studying the side effects and best dose of Azadirachta indica in treating patients with chronic lymphocytic leukemia.

Condition or Disease Intervention/Treatment Phase
  • Other: laboratory biomarker analysis
  • Genetic: western blotting
  • Genetic: gene expression analysis
  • Other: pharmacological study
  • Other: flow cytometry
  • Genetic: fluorescence in situ hybridization
  • Biological: azadirachta indica
  • Genetic: reverse transcriptase-polymerase chain reaction
 Phase 1

Detailed Description

PRIMARY OBJECTIVES: I. To determine the lowest dose of neem leaf extract (NLE) with antileukemic effect and acceptable toxicity in patients with chronic lymphocytic leukemia (CLL). II. Establish the safety and toxicity of NLE in patients with CLL. SECONDARY OBJECTIVES: I. Determine the efficacy of NLE in patients with CLL defined as overall clinical response (CR + PR) by the IWCLL criterion. II. To develop a pharmacokinetic/pharmacodynamic model relating neem leaf extract exposure to toxicity and pharmacodynamic endpoints in CLL patients that will allow personalized dosing to target optimal drug exposure. III. To conduct correlative studies. OUTLINE: This is a dose-escalation study. Patients receive oral Azadirachta indica once daily on days 1-28. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I Clinical Trial of Neem Leaf Extract for the Treatment of Chronic Lymphocytic Leukemia
Study Start Date :
Dec 1, 2010
Actual Primary Completion Date :
Jul 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I

Patients receive oral Azadirachta indica once daily on days 1-28. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Other: laboratory biomarker analysis
Correlative studies

Genetic: western blotting
Correlative studies
Other Names:
  • Blotting, Western
  • Western Blot

    • Genetic: gene expression analysis
    Correlative studies

    Other: pharmacological study
    Correlative studies
    Other Names:
  • pharmacological studies

    • Other: flow cytometry
    Correlative studies

    Genetic: fluorescence in situ hybridization
    Correlative studies
    Other Names:
  • fluorescence in situ hybridization (FISH)

    • Biological: azadirachta indica
    Given orally
    Other Names:
  • neem
  • neem tree

    • Genetic: reverse transcriptase-polymerase chain reaction
    Correlative studies
    Other Names:
  • RT-PCR

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Lowest clinically active and tolerable dose [After patients have completed at least 2 treatment courses]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients must have a definitive diagnosis of CLL as defined by the IWCLL criteria

    • Patients may not have received any prior treatment for management of CLL; (no more than 30 patients with treatment naive disease will be included in this study)

    • Patients with advance stage disease (Rai Stage II-IV) may be included in this clinical trial if they refuse to take standard chemotherapeutic regimens

    • Patients with relapsed or relapsed/ resistant may be included in this clinical trial if they refuse to take standard chemotherapeutic regimens

    • Patients must understand and voluntarily sign an informed consent form

    • Have an ECOG Performance Status of =< 2 at study entry

    • Able to adhere to the study visit schedule and other protocol requirements

    • Leukocytes >= 3,000/mcL

    • Absolute neutrophil count >= 1,500/mcL

    • Hemoglobin >= 10g/dl

    • Platelets >= 50,000/mcl

    • Total bilirubin within normal institutional limits

    • AST (SGOT)/ ALT (SGPT) =< 2.5 X institutional ULN

    • Patients of childbearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment

    • Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

    Exclusion Criteria:

    • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form

    • Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study

    • Trying to conceive, pregnant or breast feeding female patients

    • Unwilling or unable to follow protocol requirements

    • Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug

    • Patients who are consuming other herbals or non-traditional therapies (i.e. green tea extracts and cumin) within the last 4 weeks(28 days) of initiating this clinical study; note: patient must have stopped herbal or other non-traditional therapies for CLL at least 28 days prior to initiating therapy on this study

    • Patients with high-risk cytogenetic (del 17p, del 11q) determined by FISH analysis

    • Prior organ transplant

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Roswell Park Cancer Institute

    Investigators

    • Principal Investigator: Asher Chanan-Khan, Roswell Park Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Roswell Park Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT01251250
    Other Study ID Numbers:
    • I 169009
    • NCI-2010-02103
    First Posted:
    Dec 1, 2010
    Last Update Posted:
    Jan 13, 2014
    Last Verified:
    Jan 1, 2014
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Lymphoid
    Leukemia, Lymphocytic, Chronic, B-Cell

    Study Results

    No Results Posted as of Jan 13, 2014