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

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ClinicalTrials.gov Identifier: NCT00709215
Recruitment Status : Unknown
Verified January 2009 by OncoVista, Inc..
Recruitment status was:  Recruiting
First Posted : July 3, 2008
Last Update Posted : January 9, 2009
Information provided by:
OncoVista, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Refractory TdT-Positive Leukemia Drug: Cordycepin plus Pentostatin Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Cordycepin Plus Pentostatin in Patients With Refractory TdT-Positive Leukemia
Study Start Date : June 2008
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia
Drug Information available for: Pentostatin

Intervention Details:
  • Drug: Cordycepin plus Pentostatin
    Cordycepin Plus Pentostatin on days 1, 2 and 3 of a 21 day cycle. Number of cycles until progression or unacceptable toxicity

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00709215

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Contact: Michael Moloney, MBA, BS 210.677.6000 ext 201 michael.moloney@oncovista.com

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United States, Massachusetts
Brigham & Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Daniel J DeAngelo, MD, PhD.    617-632-2645    Daniel_Deangelo@dfci.harvard.edu   
Principal Investigator: Daneil J DeAngelo, MD, PhD.         
Sub-Investigator: Richard Stone, MD         
Sub-Investigator: L. Andres Sirulnik, MD         
Sub-Investigator: Martha Wadleigh, MD         
Sub-Investigator: Gregory Abel, MD, MPH         
Sub-Investigator: Susan L Buchanan, PA         
Sub-Investigator: Adriana Penicaud, PA         
Sub-Investigator: Ilene Galinsky, APRN         
Sub-Investigator: Eyal Attar, MD         
Sub-Investigator: Philip Amrein, MD         
Sub-Investigator: Karen Kuhn Ballen, MD         
United States, Texas
Cancer Therapy Reasearch Center at UTHSCA Recruiting
San Antonio, Texas, United States, 78229
Contact: Swaminathan Padmanabhan, MD    210-450-5094    PadmanabhanS@uthscsa.edu   
Sub-Investigator: Monica Mita, MD         
Principal Investigator: Alain Mita, MD         
Sponsors and Collaborators
OncoVista, Inc.
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Principal Investigator: Swaminathan Padmanabhan, MD Cancer Therapy Research Center at UTHSCSA
Principal Investigator: Daneil J DeAngelo, MD, PhD. Dana Farber Cancr Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael Moloney, Director - Program Management, OncoVista, Inc.
ClinicalTrials.gov Identifier: NCT00709215    
Other Study ID Numbers: OV06-001
First Posted: July 3, 2008    Key Record Dates
Last Update Posted: January 9, 2009
Last Verified: January 2009
Keywords provided by OncoVista, Inc.:
refractory TdT-positive leukemia
blastic CML
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Antineoplastic Agents
Adenosine Deaminase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents