- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00077181
3-AP and High-Dose Cytarabine in Treating Patients With Advanced Hematologic Malignancies
A Phase I Study of Triapine in Combination With High Dose Ara-C (Hi-DAC) in Patients With Advanced Hematologic Malignancies
Study Overview
Status
Conditions
- Recurrent Adult Acute Myeloid Leukemia
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
- Secondary Acute Myeloid Leukemia
- Accelerated Phase Chronic Myelogenous Leukemia
- Recurrent Adult Acute Lymphoblastic Leukemia
- Relapsing Chronic Myelogenous Leukemia
- Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
- Blastic Phase Chronic Myelogenous Leukemia
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of 3-AP (Triapine) administered with high-dose cytarabine in patients with advanced hematologic malignancies.
SECONDARY OBJECTIVES:
I. Determine the clinical activity of this regimen in these patients. II. Determine the effect of treatment with 3-AP (Triapine) on intracellular levels of cytarabine in these patients.
OUTLINE: This is a dose-escalation study of 3-AP (Triapine).
Patients receive high-dose cytarabine IV over 2 hours on days 1-5 and 3-AP (Triapine) IV over 2 hours on days 2-5. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients in each stratum receive escalating doses of 3-AP (Triapine) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed for up to 2 years.
PROJECTED ACCRUAL: A total of 6-48 patients (3-24 per stratum) will be accrued for this study within 15-24 months.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60637-1470
- University of Chicago Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Histologically confirmed diagnosis of 1 of the following hematologic malignancies:
- Relapsed or refractory acute myeloid leukemia (AML)
- Relapsed or refractory acute lymphoblastic leukemia
- Secondary AML, including AML arising from antecedent hematologic diseases, such as myelodysplastic syndromes or myeloproliferative disorders OR therapy-related AML
- Chronic myeloid leukemia in accelerated or blast phase
- Refractory to standard therapy or no standard therapy exists
- No known brain metastases
- Performance status - CALGB 0-2
- Performance status - Karnofsky 60-100%
- No G6PD deficiency
- Bilirubin < 2.0 mg/dL (unless due to Gilbert's syndrome)
- AST and ALT < 2.5 times upper limit of normal (ULN)
- Creatinine < 1.5 times ULN
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No pulmonary disease requiring oxygen
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior allergic reactions attributed to compounds of similar chemical or biological composition to study drugs
- No neuropathy
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No other concurrent uncontrolled illness
- No concurrent biologic agents
- At least 72 hours since prior hydroxyurea
- At least 2 weeks since other prior chemotherapy (6 weeks for mitomycin or nitrosoureas)
- No other concurrent chemotherapy
- At least 2 weeks since prior radiotherapy
- No concurrent radiotherapy
- Recovered from all prior therapy
- At least 4 weeks since prior investigational agents
- No other concurrent investigational therapy
- No other concurrent anticancer therapy
- No concurrent combination antiretroviral therapy for HIV-positive patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (cytarabine and triapine)
Patients receive high-dose cytarabine IV over 2 hours on days 1-5 and triapine IV over 2 hours on days 2-5.
Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
|
Correlative studies
Given IV
Other Names:
Given IV
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
MTD defined as the dose preceding that at which greater than or equal to 2 patients experience dose-limiting toxicity assessed using NCI CTCAE version 3.0
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms by Site
- Disease Attributes
- Bone Marrow Diseases
- Hematologic Diseases
- Myeloproliferative Disorders
- Neoplastic Processes
- Leukemia, Lymphoid
- Cell Transformation, Neoplastic
- Carcinogenesis
- Hematologic Neoplasms
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Recurrence
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Blast Crisis
- Leukemia, Myeloid, Accelerated Phase
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Cytarabine
Other Study ID Numbers
- NCI-2012-02570
- U01CA069852 (U.S. NIH Grant/Contract)
- UCCRC-12806B
- CDR0000349659 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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