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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
Sponsor:
Collaborator:
AAIPharma
Information provided by:
OncoVista, Inc.

Tracking Information
First Submitted Date  ICMJE June 30, 2008
First Posted Date  ICMJE July 3, 2008
Last Update Posted Date January 9, 2009
Study Start Date  ICMJE June 2008
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Cordycepin Plus Pentostatin in Patients With Refractory TdT-Positive Leukemia
Official Title  ICMJE A Phase I/II Study of Cordycepin Plus Pentostatin in Patients With Refractory TdT-Positive Leukemia
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.
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Refractory TdT-Positive Leukemia
Intervention  ICMJE 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
Study Arms  ICMJE Not Provided
Publications * Verma AK. Cordycepin: a bioactive metabolite of Cordyceps militaris and polyadenylation inhibitor with therapeutic potential against COVID-19. J Biomol Struct Dyn. 2022 May;40(8):3745-3752. doi: 10.1080/07391102.2020.1850352. Epub 2020 Nov 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 2, 2008)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2010
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00709215
Other Study ID Numbers  ICMJE OV06-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Michael Moloney, Director - Program Management, OncoVista, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE OncoVista, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE AAIPharma
Investigators  ICMJE
Principal Investigator: Swaminathan Padmanabhan, MD Cancer Therapy Research Center at UTHSCSA
Principal Investigator: Daneil J DeAngelo, MD, PhD. Dana Farber Cancr Institute
PRS Account OncoVista, Inc.
Verification Date January 2009

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