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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by OncoVista, Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
AAIPharma
Information provided by:
OncoVista, Inc.
ClinicalTrials.gov Identifier:
NCT00709215
First received: June 30, 2008
Last updated: January 8, 2009
Last verified: January 2009

June 30, 2008
January 8, 2009
June 2008
December 2010   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00709215 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Cordycepin Plus Pentostatin in Patients With Refractory TdT-Positive Leukemia
A Phase I/II Study of Cordycepin Plus Pentostatin in Patients With Refractory TdT-Positive Leukemia

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.

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

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Refractory TdT-Positive Leukemia
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
44
December 2010
December 2010   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact: Michael Moloney, MBA, BS 210.677.6000 ext 201 michael.moloney@oncovista.com
United States
 
NCT00709215
OV06-001
Yes
Michael Moloney, Director - Program Management, OncoVista, Inc.
OncoVista, Inc.
AAIPharma
Principal Investigator: Swaminathan Padmanabhan, MD Cancer Therapy Research Center at UTHSCSA
Principal Investigator: Daneil J DeAngelo, MD, PhD. Dana Farber Cancr Institute
OncoVista, Inc.
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP