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

NCT00709215 | Unknown Phase 1 DMC

• 1 other identifier: OV06-001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (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

  one year

Secondary Outcomes (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

  18 months

Interventions

Cordycepin plus Pentostatin DRUG

Cordycepin Plus Pentostatin on days 1, 2 and 3 of a 21 day cycle. Number of cycles until progression or unacceptable toxicity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• OncoVista, Inc.: lead
• AAIPharma: collaborator

Study Sites (3)

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

RECRUITING

Cancer Therapy Reasearch Center at UTHSCA

San Antonio, Texas, 78229, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 33225826 DERIVED

MeSH Terms

Interventions

cordycepin; Pentostatin

Intervention Hierarchy (Ancestors)

Coformycin; Formycins; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Swaminathan Padmanabhan, MD

  Cancer Therapy Research Center at UTHSCSA

  PRINCIPAL INVESTIGATOR

• Daneil J DeAngelo, MD, PhD.

  Dana Farber Cancr Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Moloney, MBA, BS

CONTACT

210.677.6000; michael.moloney@oncovista.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 30, 2008
• First Posted: July 3, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 9, 2009

Record last verified: 2009-01

Locations

US (3)