Recruiting
Phase 1
Phase 2

Cordycepin & Pentostatin

Sponsor:

OncoVista, Inc.

Code:

NCT00709215

Conditions

Refractory TdT-Positive Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cordycepin plus Pentostatin

Study Details

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.

Conditions

Refractory TdT-Positive Leukemia

Study ID

NCT00709215

Start date

Jun, 2008

Status verified date

Jan, 2009

Completion date

Dec, 2010

Anticipated

Primary completion date

Dec, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

44 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

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

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 ]

Central Contacts and Locations

Central contacts

Michael Moloney, MBA, BS

210.677.6000michael.moloney@oncovista.com

Locations

Brigham & Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Daniel J DeAngelo, MD, PhD.

617-632-2645Daniel_Deangelo@dfci.harvard.edu

Principal Investigator:

Daneil J DeAngelo, MD, PhD.

Cancer Therapy Reasearch Center at UTHSCA

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Swaminathan Padmanabhan, MD

210-450-5094PadmanabhanS@uthscsa.edu

Principal Investigator:

Alain Mita, MD

More Information

Sponsor

OncoVista, Inc.

Last update posted

Jan 9, 2009

Last verified

Jan, 2009

Keywords

  • refractory TdT-positive leukemia
  • ALL
  • AML
  • blastic CML

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by OncoVista, Inc. on 2009-01-09.