VNP40101M Followed by Cytarabine in Treating Older Patients With Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT00354276|
Recruitment Status : Unknown
Verified May 2009 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : July 20, 2006
Last Update Posted : January 10, 2014
RATIONALE: Drugs used in chemotherapy, such as VNP40101M and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving VNP40101M followed by cytarabine may kill more cancer cells.
PURPOSE: This phase II trial is studying how well VNP40101M followed by cytarabine works in treating older patients with acute myeloid leukemia.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: cytarabine Drug: laromustine||Phase 2|
- Determine the complete response rate in older patients with poor-risk, de novo acute myeloid leukemia treated with VNP40101M as induction therapy followed by cytarabine as consolidation therapy.
- Determine the probability of overall survival, leukemia-free survival, and progression-free survival of patients treated with this regimen.
- Determine the safety of this regimen in these patients.
OUTLINE: This is an open-label, multicenter study.
- Induction therapy: Patients receive VNP40101M IV over 60 minutes on day 1 (course 1). Patients without evidence of disease progression who have responding but residual disease receive a second course of VNP40101M once between days 35-60. Patients achieving complete response or partial response after induction therapy proceed to consolidation therapy.
- Consolidation therapy: Beginning between days 45-90, patients receive cytarabine IV continuously over 5 days (course 1). Patients may receive a second course of cytarabine at the discretion of the investigator.
After completion of study treatment, patients are followed periodically for up to 36 months.
PROJECTED ACCRUAL: A total of 85 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||85 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Cloretazine® (VNP40101M) for Elderly Patients With De Novo Poor Risk Acute Myelogenous Leukemia|
|Study Start Date :||May 2006|
|Estimated Primary Completion Date :||December 2008|
- Complete response rate
- Leukemia-free survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00354276
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|Hopital Haut Leveque|
|Pessac, France, 33604|
|University Hospital of Wales|
|Cardiff, Wales, United Kingdom, CF14 4XW|
|OverallOfficial:||Bonny L. Johnson, RN, MSN||Vion Pharmaceuticals|