Azadirachta Indica in Treating Patients With Chronic Lymphocytic Leukemia

NCT01251250 | Withdrawn Phase 1 DMC

• 2 other identifiers: I 169009NCI-2010-02103
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Refractory Chronic Lymphocytic Leukemia; Stage II Chronic Lymphocytic Leukemia; Stage III Chronic Lymphocytic Leukemia; Stage IV Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• Lowest clinically active and tolerable dose

  After patients have completed at least 2 treatment courses

Study Arms (1)

Arm I

EXPERIMENTAL

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; 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

Interventions

laboratory biomarker analysis OTHER

Correlative studies

Arm I

western blotting GENETIC

Correlative studies

Also known as: Blotting, Western, Western Blot

Arm I

gene expression analysis GENETIC

Correlative studies

Arm I

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Arm I

flow cytometry OTHER

Correlative studies

Arm I

fluorescence in situ hybridization GENETIC

Correlative studies

Also known as: fluorescence in situ hybridization (FISH)

Arm I

azadirachta indica BIOLOGICAL

Given orally

Also known as: neem, neem tree

Arm I

reverse transcriptase-polymerase chain reaction GENETIC

Correlative studies

Also known as: RT-PCR

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Blotting, Western; Gene Expression Profiling; Flow Cytometry; In Situ Hybridization, Fluorescence; neem oil; Reverse Transcriptase Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrophoresis; Chemistry Techniques, Analytical; Investigative Techniques; Electrochemical Techniques; Immunoblotting; Immunoassay; Immunologic Techniques; Molecular Probe Techniques; Genetic Techniques; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; In Situ Hybridization; Staining and Labeling; Histocytological Preparation Techniques; Histological Techniques; Cytogenetic Analysis; Nucleic Acid Hybridization; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques

Study Officials

• Asher Chanan-Khan

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2010
• First Posted: December 1, 2010
• Study Start: December 1, 2010
• Primary Completion: July 1, 2011
• Last Updated: January 13, 2014

Record last verified: 2014-01