Status:
TERMINATED
Treatment of Elderly Patients With Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic (MD) Syndrome With Laromustine and Infusional Cytarabine
Lead Sponsor:
Viron Therapeutics Inc
Collaborating Sponsors:
Vion Pharmaceuticals
Conditions:
Acute Myeloid Leukemia (AML)
Myelodysplastic Syndrome (MDS)
Eligibility:
All Genders
60+ years
Phase:
PHASE1
PHASE2
Brief Summary
* The purpose of the Phase I portion of this study is to evaluate the safety of this combination of medications and to determine the appropriate dose of VNP40101M to be used in combination with infusi...
Detailed Description
There is no known standard chemotherapy that is considered effective for older patients with AML or high risk MDS at this time, and with current treatment, tumor reduction can be difficult to achieve ...
Eligibility Criteria
Inclusion
- Diagnosis of AML based on WHO criteria (greater than 20% blasts in the bone marrow or blood) excluding AML M3, acute promyelocytic leukemia OR diagnosis of high-risk MDS defined as International Prognostic Scoring System INT-2.
- ECOG performance status equal to 0, 1, 2.
- No prior treatment for AML with myeloablative treatment. Patients may have prior treatment with a biologic therapy. Patients with MDS or AML that has evolved from MDS could have received prior low-dose cytotoxic therapy with agents such as azacytidine or low-dose Ara C.
- Ability to sign an Informed Consent according to institutional guidelines.
- Patients must have the following clinical laboratory values within 24 hours prior to beginning protocol treatment: a) serum creatinine less than or equal to 2.0mg/dl. b) total bilirubin less than or equal to 2.0 mg/dl c) ALT or AST less than or equal to 5 times the upper limit of normal.
Exclusion
- Uncontrolled active infection. Patients with infections who are under active treatment with antibiotics and whose infections are controlled may be entered into the study. Patients with chronic hepatitis are eligible.
- Active heart disease including myocardial infarction, symptomatic coronary artery disease, arrhythmias not controlled by medication or uncontrolled congestive heart failure.
- Severe pulmonary disease not controlled with medication.
- Patients with serum creatinine \> 2.0, serum bilirubin \> 2.0. ALT or AST greater that 5 times the upper limit of normal. Patients with bilirubin or creatinine outside the acceptable levels will be considered eligible if this abnormality is clearly leukemia related and discussed with the principal's investigator prior to enrollment.
- Patients concurrently receiving any other standard or investigational treatment for leukemia with the exception of hydroxyurea.
- Since the formulation contains 30% ethanol, patients being treated with Antabuse (disulfiram) are excluded from the study.
- Patients with APL t(15;17)
- Patients with ECOG performance status of 3 or 4.
- Patients should be off metronidazole (Flagyl) at least 24 hours before starting laromustine.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00655395
Start Date
March 1 2008
End Date
October 1 2010
Last Update
January 28 2019
Active Locations (1)
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1
Weill Cornell Medical College
New York, New York, United States, 10021