Troxacitabine in Treating Patients With Chronic Myelogenous Leukemia

NCT ID: NCT00012259

Last Updated: 2021-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-12-11
• Study Completion Date: 2002-03-27

Brief 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.

Detailed 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.

Conditions

Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

troxacitabine

Group Type: EXPERIMENTAL

troxacitabine

Intervention Type: DRUG

Interventions

troxacitabine

Intervention Type: DRUG

Other Intervention Names

8 mg/m2 administered IV over 30 minutes per day for 5 consecutive days

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Cancer Center and Beckman Research Institute, City of Hope

Duarte, California, United States

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Cedars-Sinai Comprehensive Cancer Center

Los Angeles, California, United States

MD Anderson Cancer Center Orlando

Orlando, Florida, United States

Northwestern University Medical Center

Chicago, Illinois, United States

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Johns Hopkins Oncology Center

Baltimore, Maryland, United States

Cancer Center of Albany Medical Center

Albany, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

New York Medical College

Valhalla, New York, United States

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, United States

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, United States

Baylor University Medical Center

Dallas, Texas, United States

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Health Sciences Centre

Winnipeg, Manitoba, Canada

Ottawa General Hospital

Ottawa, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

Royal Victoria Hospital - Montreal

Montreal, Quebec, Canada

Countries

United States; Canada

Other Identifiers

CDR0000068498

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-V01-1648

Identifier Type: -

Identifier Source: secondary_id

BCH-4556-214

Identifier Type: -

Identifier Source: org_study_id