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A Phase II Study Of Troxatyl In Patients With CML Blastic Phase Disease


Phase 2
16 Years
N/A
Not Enrolling
Both
Leukemia

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Trial Information

A Phase II Study Of Troxatyl In Patients With CML Blastic Phase Disease


OBJECTIVES: I. Determine the response rate, in terms of achieving complete hematologic
remission, partial hematologic remission, hematologic improvement, partial response, or back
to chronic phase status, in patients with blastic phase chronic myelogenous leukemia treated
with troxacitabine. II. Determine the proportion of patients whose disease returns to
chronic phase and remains at that level for at least 3 months when treated with this drug.
III. Determine the toxicity profile of this drug in these patients. IV. Determine the
duration of survival of patients treated with this drug.

OUTLINE: This is a multicenter study. Patients receive troxacitabine IV over 30 minutes on
days 1-5. Treatment repeats every 4 weeks in the absence of disease progression or
unacceptable toxicity. Patients are followed every 4 weeks until relapse.

PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study within 14 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Diagnosis of Philadelphia chromosome-positive blastic phase
chronic myelogenous leukemia (CML) with blasts of non-lymphoid origin Blastic phase
defined as: At least 30% blasts in the blood or bone marrow OR Presence of extramedullary
infiltration outside the liver or spleen No leukemic CNS involvement

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL
AST or ALT less than 3 times upper limit of normal Renal: Creatinine no greater than 1.5
mg/dL OR Creatinine less than 1.8 mg/dL if creatinine clearance at least 45 mL/min Other:
No known hypersensitivity to troxacitabine or its analogues No active uncontrolled serious
infection No other severe medical condition that would preclude study No neurologic or
psychiatric disorders that would preclude informed consent No uncontrolled underlying
medical condition or underlying condition that could be aggrevated by treatment Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 24 hours
since prior hydroxyurea Prior STI571 for blastic phase chronic myelogenous leukemia
allowed No other prior chemotherapy for blastic phase disease Endocrine therapy: Not
specified Radiotherapy: Not specified Surgery: Not specified Other: At least 14 days since
prior investigational agents and recovered No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Conventional Response Rate

Outcome Description:

Conventional Response Rate defined as the achievement of complete hematologic remission (CHR), partial hematologic remission (PHR), hematologic improvement (HI), partial response (PR), or back to chronic phase (BCP).

Safety Issue:

No

Principal Investigator

Francis J. Giles, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

SHIRE-BCH-4556-214

NCT ID:

NCT00012259

Start Date:

October 2000

Completion Date:

Related Keywords:

  • Leukemia
  • relapsing chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • chronic myelogenous leukemia, BCR-ABL1 positive
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Chicago Cancer Research CenterChicago, Illinois  60637
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
Cancer Center of Albany Medical CenterAlbany, New York  12208
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
MD Anderson Cancer Center OrlandoOrlando, Florida  32806
New York Medical CollegeValhalla, New York  10595
Cancer Center and Beckman Research Institute, City of HopeDuarte, California  91010-3000
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Baylor University Medical CenterDallas, Texas  75246
Northwestern University Medical CenterChicago, Illinois  60611
Cedars-Sinai Comprehensive Cancer CenterLos Angeles, California  90048