Clinical Trials /

Study of Cordycepin Plus Pentostatin in Patients With Refractory TdT-Positive Leukemia

NCT00709215

Description:

This is a two-part, open-label, Phase I/II study in subjects with relapsed or refractory TdT-positive leukemia for which no standard therapies are expected to result in durable remission.

Related Conditions:
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Chronic Myeloid Leukemia
Recruiting Status:

Unknown status

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Cordycepin Plus Pentostatin in Patients With Refractory TdT-Positive Leukemia
  • Official Title: A Phase I/II Study of Cordycepin Plus Pentostatin in Patients With Refractory TdT-Positive Leukemia

Clinical Trial IDs

  • ORG STUDY ID: OV06-001
  • NCT ID: NCT00709215

Conditions

  • Refractory TdT-Positive Leukemia

Interventions

DrugSynonymsArms
Cordycepin plus Pentostatin

Purpose

This is a two-part, open-label, Phase I/II study in subjects with relapsed or refractory TdT-positive leukemia for which no standard therapies are expected to result in durable remission.

Detailed Description

      In the first phase the Study Objectives are to:

        -  Define the maximally tolerated dose (MTD) and recommended dose (RD) for administration
           of cordycepin as a 1-hour IV infusion, administered 1 hour following administration of
           an IV bolus of pentostatin, in subjects with refractory TdT-positive leukemia;

        -  Determine plasma ADA levels prior to pentostatin infusion and at 60 and 120 minutes
           after administration of pentostatin;

        -  Determine the single and multiple dose pharmacokinetics (PK) of cordycepin given 1 hour
           after a fixed dose of pentostatin;

        -  Assess cordycepin pharmacodynamics by measurement of blast cell apoptosis from
           peripheral blood smears;

        -  Measure and quantitate any clinical responses in refractory TdT-positive leukemia
           patients following cordycepin/pentostatin administration.

      In the second phase, the Study Objectives are to assess the safety, PK, and clinical outcomes
      of cordycepin in combination with pentostatin, at the RD, in a 20 subject cohort
    

Trial Arms

NameTypeDescriptionInterventions

Eligibility Criteria

        Inclusion Criteria:

          -  TdT-positive leukemia (ALL, AML, or blastic CML) that has failed at least one standard
             treatment regimen and for which no standard therapies are expected to result in
             durable remission. Leukemia is minimally defined as at least 20% blast cells present
             in marrow or peripheral blood. TdT must be expressed in at least 20% of blast cells
             present and documented either immunologically or biochemically;

          -  Age ≥18 years;

          -  Must understand and voluntarily sign informed consent;

          -  Adequate non-hematologic organ system function, defined by:

               -  Creatinine ≤1.5 times the upper limit of normal (ULN) and/or creatinine clearance
                  ≥60 mL/min

               -  AST and/or ALT ≤2.5 times upper limit of normal (ULN)

               -  Total bilirubin within institutional normal range

               -  Normal EKG and LVEF >40%, measured by EKG and MUGA scan, radionuclide
                  ventriculogram, or echocardiogram

          -  Life expectancy >3 months;

          -  Performance status (PS) >70% Karnofsky or ECOG ≤2;

          -  Women of childbearing potential must have a negative serum pregnancy test within 7
             days of starting study drug. A woman of child-bearing potential is a sexually mature
             woman who has not undergone a hysterectomy or who has not been naturally
             postmenopausal for at least 24 consecutive months (i.e., who has had menses at any
             time in the preceding 24 consecutive months);

          -  Male or female of child-bearing potential must agree to use adequate contraceptive
             methods

        Exclusion Criteria:

          -  Failure to meet inclusion criteria;

          -  Uncontrolled active infection;

          -  Extramedullary (CNS) disease;

          -  Serious concomitant medical illness, such as active infection, uncontrolled congestive
             heart failure, or uncontrolled diabetes or other metabolic disorder, or psychiatric
             illness;

          -  Pregnancy or lactation; females of child bearing potential must use adequate
             contraceptive methods;

          -  Less than 3 weeks since prior chemotherapy, radiation therapy, or immunotherapy.
             However, hydroxyurea is permitted up to 24 hours before the study is initiated;

          -  Less than 2 months following bone marrow or peripheral blood stem cell transplantation
             or treatment with donor lymphocyte infusion (DLI).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Establishment of the recommended dose (RD) of cordycepin, given one hour following a fixed dose of the ADA inhibitor pentostatin, in subjects with refractory TdT-positive leukemia
Time Frame:one year
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Determination of the single and multiple dose pharmacokinetics of cordycepin. Measurement and quantification any any clinical responses following administration of cordycepin/pentostatin at the recomme
Time Frame:18 months
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Unknown status
Lead Sponsor:OncoVista, Inc.

Trial Keywords

  • refractory TdT-positive leukemia
  • ALL
  • AML
  • blastic CML

Last Updated