A Phase II Study Of Troxatyl In Patients With CML Blastic Phase Disease
16 Years
N/A
Both
Leukemia
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 Center | New York, New York 10021 |
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |
| Cancer Center of Albany Medical Center | Albany, New York 12208 |
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
| Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
| University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
| MD Anderson Cancer Center Orlando | Orlando, Florida 32806 |
| New York Medical College | Valhalla, New York 10595 |
| Cancer Center and Beckman Research Institute, City of Hope | Duarte, California 91010-3000 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| Baylor University Medical Center | Dallas, Texas 75246 |
| Northwestern University Medical Center | Chicago, Illinois 60611 |
| Cedars-Sinai Comprehensive Cancer Center | Los Angeles, California 90048 |
