A Phase 1 interventional study of cytarabine and laromustine in Leukemia and Myelodysplastic Syndromes, sponsored by Vion Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-07-18.
Sponsored by Vion Pharmaceuticals · Phase 1, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy, such as VNP40101M and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of combining VNP40101M with cytarabine in treating patients who have hematologic malignancies, including myelodysplastic syndrome or relapsed, refractory, or untreated leukemia.
OBJECTIVES:
OUTLINE: This is an open-label, dose-escalation study of VNP40101M.
Patients receive cytarabine IV over 24 hours on days 1-4 for patients under 65 years of age OR on days 1-3 for patients 65 years of age and over. Patients also receive VNP40101M IV over 15-60 minutes on day 2. Treatment repeats every 4 weeks for up to 3 courses (in patients with responding disease) in the absence of disease progression or unacceptable toxicity. Patients with a continued response may receive additional courses at the discretion of the investigator.
Cohorts of 3-6 patients receive escalating doses of VNP40101M 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. Up to 10 patients may receive treatment at the MTD.
PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
Browse Leukemia studies →Vion Pharmaceuticals is the lead sponsor of 20 studies on the registry; none are open to participants now.
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DISEASE CHARACTERISTICS:
Diagnosis of leukemia or myelodysplastic syndromes (MDS) meeting criteria for 1 of the following:
Relapsed or refractory leukemia for which there is no standard therapy anticipated to result in a durable remission
Chronic myelogenous leukemia
Any of the following poor-risk MDS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
No uncontrolled active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.
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Vion Pharmaceuticals