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An Open-Label, Single-Arm, Multi-Center, Phase II Study of Troxatyl™ (Troxacitabine) Administered by Continuous Infusion in Patients With Acute Myeloid Leukemia (AML) in Second Salvage


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia, Myeloid, Acute

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Trial Information

An Open-Label, Single-Arm, Multi-Center, Phase II Study of Troxatyl™ (Troxacitabine) Administered by Continuous Infusion in Patients With Acute Myeloid Leukemia (AML) in Second Salvage


This is a phase 2, single-arm, open-label, multi-center study to establish the safety and
efficacy of Troxatyl™ (troxacitabine) administered as a continuous infusion for 5 days to
subjects with AML. The study will primarily assess the complete response (CR) rate of a
5-day continuous infusion of troxacitabine at 12 mg/m2/day given as second salvage therapy
in adult patients with AML, with secondary objectives to determine the overall, relapse-free
and event-free survival and remission duration; to determine the duration of response; to
determine the complete response with incomplete platelet recovery (CRp) rate; to evaluate
the tolerability and safety of 5-day continuous intravenous (IV) infusion of troxacitabine;
and to determine the relationship between troxacitabine plasma concentrations, anti-leukemic
activity and adverse events. Additional cycles of treatment may be given at the
investigator’s discretion, provided that the subject does not have progressive disease or
experience a dose limiting toxicity. Bone marrow transplantation in responding subjects will
be allowed.


Inclusion Criteria:



- Confirmed diagnosis of acute myeloid leukemia (AML) in the second salvage setting:
refractory to two prior courses of therapy or primary refractory without response to
two previous courses of leukemia therapy.

- Patients must have received at least two previous courses of induction chemotherapy
to be considered in the second salvage setting.

- Patients who are in second relapse, must have had a duration of their second CR or
CRp of less than six months.

- Subjects must have adequate organ and immune function as indicated by the following
laboratory values:

- Creatinine clearance ≥ 45 mL/min and ≤ 125 mL/min;

- Total bilirubin ≤ 2.0 mg/dL (≤ 34.2 µmol/L);

- AST (SGOT) and ALT (SGPT) ≤ 3 x upper limit of normal (ULN).

- Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance
status of < 2, and an estimated life expectancy of at least eight weeks.

Exclusion Criteria:

- Clinical evidence of active central nervous system (CNS) leukemic involvement

- Active and uncontrolled infection

- Uncontrolled medical problems unrelated to the malignancy that impair patient ability
to give informed consent or unacceptably reduce the safety of the proposed treatment

- Neurologic or psychiatric disorders that would interfere with informed consent or
study follow-up

- Known or suspected intolerance or hypersensitivity to Troxatyl® or closely related
compounds such as lamivudine or any of the stated ingredients

- A recent history of alcohol or other substance abuse

- Subjects who have used another investigational agent or participated in a clinical
trial within the last 14 days prior to enrolment

- Females with a positive pregnancy test at screening

- Subjects who have previously been enrolled into this study and subsequently withdrew

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine complete response (CR) rate

Principal Investigator

Francis Giles, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

SPD758-216

NCT ID:

NCT00129948

Start Date:

July 2005

Completion Date:

October 2007

Related Keywords:

  • Leukemia, Myeloid, Acute
  • Acute myeloid leukemia
  • AML
  • refractory
  • relapsed
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Cleveland Clinic FoundationCleveland, Ohio  44195
Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Washington University School of MedicineSaint Louis, Missouri  63110
Loyola University Medical CenterMaywood, Illinois  60153
Scripps ClinicLa Jolla, California  92037
Morgantown Internal Medicine GroupMorgantown, West Virginia  26505
Dana Farber Cancer InstituteBoston, Massachusetts  02115
University of ChicagoChicago, Illinois  60637
UCSD Moores Cancer CenterLa Jolla, California  93093
USC-Norris Neuro-Oncology ProgramLos Angeles, California  90033
Univ. of Florida, Baptist Cancer CenterJacksonville, Florida  32209
Winship Cancer Institute, Emory University Hosp.Atlanta, Georgia  30322
Harper Hospital - Karmanos Cancer CenterDetroit, Michigan  48201
Univ. of Minnesota Medical CenterMinneapolis, Minnesota  55455
New York Presbyterian Hospital-Cornell CampusNew York, New York  10021
Wake Forest Univ. School of MedicineWinston-Salem, North Carolina  27157
Univ. of South Carolina, Hematology/Oncology DivisionCharleston, South Carolina  29425
Univ. of Texas, MD Anderson Cancer CenterHouston, Texas  77030
University of Utah Huntsman Cancer InstituteSalt Lake City, Utah  84112