Status:
UNKNOWN
Study of Cordycepin Plus Pentostatin in Patients With Refractory TdT-Positive Leukemia
Lead Sponsor:
OncoVista, Inc.
Collaborating Sponsors:
AAIPharma
Conditions:
Refractory TdT-Positive Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 fol...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00709215
Start Date
June 1 2008
End Date
December 1 2010
Last Update
January 9 2009
Active Locations (3)
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1
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Cancer Therapy Reasearch Center at UTHSCA
San Antonio, Texas, United States, 78229