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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2009 by OncoVista, Inc..
Recruitment status was:  Recruiting
Information provided by:
OncoVista, Inc. Identifier:
First received: June 30, 2008
Last updated: January 8, 2009
Last verified: January 2009
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 Intervention Phase
Refractory TdT-Positive Leukemia Drug: Cordycepin plus Pentostatin Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by OncoVista, Inc.:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 44
Study Start Date: June 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00709215

Contact: Michael Moloney, MBA, BS 210.677.6000 ext 201

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   
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   
Sub-Investigator: Monica Mita, MD         
Principal Investigator: Alain Mita, MD         
Sponsors and Collaborators
OncoVista, Inc.
Principal Investigator: Swaminathan Padmanabhan, MD Cancer Therapy Research Center at UTHSCSA
Principal Investigator: Daneil J DeAngelo, MD, PhD. Dana Farber Cancr Institute
  More Information

Responsible Party: Michael Moloney, Director - Program Management, OncoVista, Inc. Identifier: NCT00709215     History of Changes
Other Study ID Numbers: OV06-001
Study First Received: June 30, 2008
Last Updated: January 8, 2009

Keywords provided by OncoVista, Inc.:
refractory TdT-positive leukemia
blastic CML

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Antineoplastic Agents
Adenosine Deaminase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents processed this record on August 23, 2017