Myeloproliferative Neoplasms Clinical Trial

Troxacitabine in Treating Patients With Chronic Myelogenous Leukemia

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of troxacitabine in treating patients who have blast phase chronic myelogenous leukemia.

View Full Description

Full Description

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

31

Study ID:

NCT00012259

Recruitment Status:

Completed

Sponsor:

Shire

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 20 Locations for this study

See Locations Near You

Cancer Center and Beckman Research Institute, City of Hope
Duarte California, 91010, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles California, 90033, United States
Cedars-Sinai Comprehensive Cancer Center
Los Angeles California, 90048, United States
MD Anderson Cancer Center Orlando
Orlando Florida, 32806, United States
Northwestern University Medical Center
Chicago Illinois, 60611, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
Johns Hopkins Oncology Center
Baltimore Maryland, 21231, United States
Cancer Center of Albany Medical Center
Albany New York, 12208, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
New York Medical College
Valhalla New York, 10595, United States
Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States
University of Pennsylvania Cancer Center
Philadelphia Pennsylvania, 19104, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia Pennsylvania, 19107, United States
Baylor University Medical Center
Dallas Texas, 75246, United States
University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States
Health Sciences Centre
Winnipeg Manitoba, R3A 1, Canada
Ottawa General Hospital
Ottawa Ontario, K1H 8, Canada
Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada
Maisonneuve-Rosemont Hospital
Montreal Quebec, H1T 2, Canada
Royal Victoria Hospital - Montreal
Montreal Quebec, H3A 1, Canada

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 2

Estimated Enrollment:

31

Study ID:

NCT00012259

Recruitment Status:

Completed

Sponsor:


Shire

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider