Clinical Trials /

PH 2 ADI-PEG 20 Acute Myeloid Leukemia

NCT01910012

Description:

Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrade arginine. ADI has been formulated with polyethylene glycol and has been used to treat patients that have cancers that require arginine. In this study, the investigators will evaluate the response rate, as determined by the revised International Working Group recommendations.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: PH 2 ADI-PEG 20 Acute Myeloid Leukemia
  • Official Title: Phase 2 Study of ADI-PEG 20 in Acute Myeloid Leukemia

Clinical Trial IDs

  • ORG STUDY ID: POLARIS2012-001
  • NCT ID: NCT01910012

Conditions

  • Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
ADI-PEG 20arginine deiminase formulated with polyethylene glycolADI-PEG 20

Purpose

Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrade arginine. ADI has been formulated with polyethylene glycol and has been used to treat patients that have cancers that require arginine. In this study, the investigators will evaluate the response rate, as determined by the revised International Working Group recommendations.

Trial Arms

NameTypeDescriptionInterventions
ADI-PEG 20Experimentalarginine deiminase formulated with polyethlene glycol
  • ADI-PEG 20

Eligibility Criteria

        Inclusion Criteria:

          1. Acute myeloid leukemia (AML) diagnosed by morphologic, histochemical or cell surface
             marker criteria.

          2. Patients with AML must have either:

             (a) relapsed or refractory leukemia after receiving at least one prior conventional
             induction therapy. Those in early first relapse must not have a matched donor and/or
             they must not be a candidate for allogeneic stem cell transplantation (usually this
             would mean the patient is too ill, obese, has a co-morbid condition or is over the age
             of 55 years) or (b) poor-risk AML as defined below: (i) Treatment related AML, except
             if it is associated with favorable cytogenetics (e.g., inversion 16, t(16;16),
             t(8;21), t(15;17), and not a candidate for stem cell transplantation, or (ii) AML with
             an antecedent hematologic disease (e.g., MDS, myelofibrosis, polycythemia vera, etc.),
             and not a candidate for stem cell transplantation.

             (iii) De novo AML > 70 years of age. (iv) AML with unfavorable cytogenetics regardless
             of age (>18 years), if patients are not candidates for allogeneic transplantation.
             Unfavorable cytogenetics are the following: complex (>3 abnormalities), -7, -5, 7q-,
             5q-, abnormalities of 11q23 excluding t(9;11), t(9;22), inversion 3, t(3;3), t(6;9).

             (c) Patients older than 60 years of age who had AML (i.e., > 20% bone marrow blasts)
             and no prior therapy for AML

          3. Age ≥ 18 years.

          4. ECOG performance status of 0-2.

          5. Post-menarche female subjects and male subjects must be asked to use appropriate
             contraception for both the male and female for the duration of the study. Subjects
             must agree to use two forms of contraception or agree to refrain from intercourse for
             the duration of the study. Females must not be pregnant at the start of the study, and
             a serum human chorionic gonadotropin (HCG) pregnancy test must be negative before
             entry into the study.

        Exclusion Criteria:

          1. Patients with infections requiring intravenous (IV) antibiotic/antiviral therapy are
             not eligible for entry onto the study; patients on prophylactic antibiotics or
             antivirals are acceptable.

          2. Pregnancy or lactation.

          3. Expected non-compliance.

          4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure (New York Heart Association Class III
             or IV), cardiac arrhythmia, psychiatric illness, social situations that would limit
             compliance with study requirements or DIC.

          5. Subjects who have had any anticancer treatment prior to entering the study and have
             not recovered to baseline (except alopecia) or≤ Grade 1 AEs, or deemed irreversible
             from the effects of prior cancer therapy. AEs > Grade 1 that are not considered a
             safety risk by the Sponsor and investigator may be allowed upon agreement with both.

          6. Subjects with history of another primary cancer, including co-existent second
             malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b)
             curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no
             known active disease present in the opinion of the investigator will not affect
             patient outcome in the setting of current diagnosis.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Response Rate
Time Frame:2 years estimated
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Safety and tolerability
Time Frame:2 years estimated
Safety Issue:
Description:Time on treatment Overall survival Evaluate the response rate and correlate with patient disease burden, and type of disease. Determine the pharmacodynamics of ADI-PEG 20 Determine the immunogenicity of ADI-PEG 20

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Polaris Group

Trial Keywords

  • Argininosuccinate Synthetase
  • Arginine
  • Arginine deiminase
  • Failed prior systemic therapy

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