- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00655395
Treatment of Elderly Patients With Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic (MD) Syndrome With Laromustine and Infusional Cytarabine
A Phase I/Phase II Evaluation of Laromustine (VNP40101M), A Sulfonylhydrazine Alkylating Agent, Combined With Infusional Cytarabine in Elderly Patients With Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome
- 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 infusional cytarabine (araC) in elderly patients with Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS).
- The purpose of the Phase II portion of the study is to evaluate the effectiveness (overall response rate) for patients treated with VNP40101M and infusional cytarabine induction therapy.
Study Overview
Status
Intervention / Treatment
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 and is short-lived. We are, therefore, interested in developing new drugs that might have a longer-lasting effect against disease.
Laromustine is a new drug that has been shown to have anti-cancer activity in animal and human studies. It interacts with the DNA of a cancer cell and kills the cell. Cytarabine (AraC) is a commercially available chemotherapy drug that is active against leukemia and used routinely when the disease is first diagnosed. In previous studies, when higher doses of laromustine were given, laromustine and AraC achieved more responses than patients treated with AraC alone. However, this advantage was offset by the fact that more patients given laromustine/AraC died to due side effects. We wish to determine the effectiveness of laromustine in combination with infusional AraC in AML and high risk MDS patients who are 60 or more years of age.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Weill Cornell Medical College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
|
Experimental: 2
|
|
Experimental: 3
|
|
Experimental: 5
|
|
Experimental: 4
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The objectives of this study are to evaluate the safety and efficacy of VNP40101M in combination with infusional Ara C as induction therapy in elderly patients with AML or high-risk MDS evolving to AML.
Time Frame: Subjects will be closely monitored continuously throughout the study.
|
Subjects will be closely monitored continuously throughout the study.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The secondary objective of this study is to evaluate this regimen for toxicities in this elderly population.
Time Frame: Subjects will be closely monitored continuously throughout the study.
|
Subjects will be closely monitored continuously throughout the study.
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0702009008
- VNP40101M
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.
Clinical Trials on Acute Myeloid Leukemia (AML)
-
Goethe UniversityCompleted
-
Daiichi Sankyo, Inc.CompletedAMLUnited States, Korea, Republic of, Taiwan, United Kingdom, France, Australia, Spain, Italy, Canada, Singapore, Germany, Netherlands, Hong Kong, Belgium, Croatia, Czechia, Hungary, Poland, Serbia
-
Gemin XCompleted
-
German Cancer Research CenterUniversity Hospital Heidelberg; University Hospital DresdenNot yet recruitingRelapsed/Refractory Acute Myeloid Leukemia (AML)Germany
-
Georgetown UniversityNational Heart, Lung, and Blood Institute (NHLBI); Jazz PharmaceuticalsRecruitingAcute Myeloid Leukemia (AML) in RemissionUnited States
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.RecruitingNewly Diagnosed Acute Myeloid Leukemia (AML)China
-
Tarapeutics Science Inc.RecruitingRelapsed or Refractory Acute Myeloid Leukemia (AML)China
-
Zhejiang ACEA Pharmaceutical Co. Ltd.Recruiting
-
Tarapeutics Science Inc.RecruitingRelapsed or Refractory Acute Myeloid Leukemia (AML)China
-
The First Affiliated Hospital of Xiamen UniversityFujian Cancer Hospital; Huizhou Municipal Central Hospital; Chipscreen Biosciences... and other collaboratorsRecruitingLeukemia, Myeloid, Acute | AML Stage, AdultChina
Clinical Trials on Laromustine (VNP40101M) and Ara-C
-
Pediatric Brain Tumor ConsortiumNational Cancer Institute (NCI)CompletedVNP40101M in Treating Young Patients With Recurrent, Progressive, or Refractory Primary Brain TumorsBrain and Central Nervous System TumorsUnited States
-
Vion PharmaceuticalsCompletedLymphoma | Small Intestine Cancer | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Vion PharmaceuticalsCompletedLymphoma | Small Intestine Cancer | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Vion PharmaceuticalsCompletedMyelodysplastic Syndromes | Leukemia | Myelodysplastic/Myeloproliferative NeoplasmsUnited States
-
Xuejie JiangRecruitingLeukemia, MyeloidChina
-
POM Wonderful LLCCompletedMale InfertilityUnited States
-
University of California, IrvinePomegranate Health; Jarrow PharmaceuticalsUnknownBenign Prostatic HyperplasiaUnited States
-
University of California, Los AngelesCompletedSkin Photoaging, Inflammation and Skin Pathogenic BacteriaUnited States
-
Xiaofan ZhuCompleted
-
University of LeedsCompletedHyperglycaemiaUnited Kingdom