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Sponsors and Collaborators: |
Weill Medical College of Cornell University Vion Pharmaceuticals |
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Information provided by: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT00655395 |
Condition | Intervention | Phase |
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Acute Myeloid Leukemia (AML) Myelodysplastic Syndrome (MDS) |
Drug: Laromustine (VNP40101M) and Ara-C |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 52 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
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Drug: Laromustine (VNP40101M) and Ara-C
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2: Experimental
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Drug: Laromustine (VNP40101M) and Ara-C
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3: Experimental
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Drug: Laromustine (VNP40101M) and Ara-C
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4: Experimental
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Drug: Laromustine (VNP40101M) and Ara-C
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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.
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Tania Curcio, R.N. | 212-746-2571 | tjc9003@med.cornell.edu |
United States, New York | |
Weill Cornell Medical College | Recruiting |
New York, New York, United States, 10021 | |
Contact: Tania Curico, R.N. 212-746-2571 tjc9003@med.cornell.edu | |
Principal Investigator: Ellen Ritchie, M.D. |
Responsible Party: | Weill Medical College of Cornell University ( Ellen Ritchie, M.D. / Assistant Professor or Medicine ) |
Study ID Numbers: | 0702009008, VNP40101M |
Study First Received: | April 3, 2008 |
Last Updated: | April 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00655395 |
Health Authority: | United States: Food and Drug Administration |
Leukemia MDS |
Myelodysplastic syndromes Precancerous Conditions Hematologic Diseases Myelodysplastic Syndromes Myelodysplasia Acute myelogenous leukemia Leukemia, Myeloid |
Leukemia, Myeloid, Acute Leukemia Preleukemia Bone Marrow Diseases Acute myelocytic leukemia Cytarabine |
Neoplasms Pathologic Processes Disease Neoplasms by Histologic Type Syndrome |