ClinicalTrials.gov

History of Changes for Study: NCT00709215
Study of Cordycepin Plus Pentostatin in Patients With Refractory TdT-Positive Leukemia
Latest version (submitted January 8, 2009) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 July 2, 2008 None (earliest Version on record)
2 July 14, 2008 Contacts/Locations and Study Status
3 January 8, 2009 Recruitment Status, Study Status and Contacts/Locations
Comparison Format:

Scroll up to access the controls

Study NCT00709215
Submitted Date:  July 2, 2008 (v1)

Open or close this module Study Identification
Unique Protocol ID: OV06-001
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
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2008
Overall Status: Recruiting
Study Start: June 2008
Primary Completion: December 2010 [Anticipated]
Study Completion: December 2010 [Anticipated]
First Submitted: June 30, 2008
First Submitted that
Met QC Criteria:
July 2, 2008
First Posted: July 3, 2008 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 2, 2008
Last Update Posted: July 3, 2008 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: OncoVista, Inc.
Responsible Party:
Collaborators: AAIPharma
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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

Open or close this module Conditions
Conditions: Refractory TdT-Positive Leukemia
Keywords: refractory TdT-positive leukemia
ALL
AML
blastic CML
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms:
Masking: None (Open Label)
Allocation: N/A
Enrollment: 44 [Anticipated]
Open or close this module Arms and Interventions
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
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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).
Open or close this module Contacts/Locations
Study Officials: Alain Mita, MD
Principal Investigator
Cancer Therapy Research Center at UTHSCSA
Daneil J DeAngelo, MD, PhD.
Principal Investigator
Dana Farber Cancr Institute
Locations: United States, Massachusetts
Dana Farber Cancer Institute
[Not yet recruiting]
Boston, Massachusetts, United States, 02115
Contact:Contact: Daniel J DeAngelo, MD, PhD. 617-632-2645 Daniel_Deangelo@dfci.harvard.edu
Contact:Principal Investigator: Daneil J DeAngelo, MD, PhD.
United States, Texas
Cancer Therapy Reasearch Center at UTHSCA
[Recruiting]
San Antonio, Texas, United States, 78229
Contact:Contact: Alain Mita, MD 210-450-5094 mita@uthscsa.edu
Contact:Sub-Investigator: Monica Mita, MD
Contact:Principal Investigator: Alain Mita, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services