Leukemia |
General leukemia; Leukemia cancer |
Clinical Trial: VNP40101M in Treating Patients With Relapsed or Refractory Leukemia or Myelodysplastic Syndrome
This study is no longer recruiting patients.
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of VNP40101M in treating patients who have relapsed or refractory leukemia or myelodysplastic syndrome.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| acute leukemia atypical chronic myeloid leukemia chronic leukemia Hairy Cell Leukemia myelodysplastic and myeloproliferative disease Prolymphocytic Leukemia | Drug: VNP40101M Procedure: chemotherapy | Phase I |
MedlinePlus related topics: Blood and Blood Disorders; Cancer; Cancer Alternative Therapy; Immune System and Disorders; Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood; Lymphatic Diseases
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of VNP40101M in Patients With Relapsed or Refractory Leukemia or Poor-Risk Myelodysplastic Syndromes
OBJECTIVES:
- Determine the toxic effects of VNP40101M in patients with relapsed or refractory leukemia or poor-risk myelodysplastic syndromes.
- Determine the maximum tolerated dose of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the antitumor effects of this drug in these patients.
OUTLINE: Patients receive VNP40101M IV over 15 minutes once every 4 weeks.
PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Relapsed or refractory leukemia for which no standard therapy is anticipated to result in a durable remission OR
- Poor-risk myelodysplastic syndromes
PATIENT CHARACTERISTICS: Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST and ALT no greater than 3 times ULN
Renal
- Creatinine no greater than 2.0 mg/dL
Cardiovascular
- No myocardial infarction within the past 3 months
- No symptomatic coronary artery disease
- No uncontrolled arrhythmia
- No uncontrolled congestive heart failure
Other
- No uncontrolled active infection
PRIOR CONCURRENT THERAPY: Biologic therapy
- Prior biologic therapy allowed
Chemotherapy
- At least 2 weeks since prior myelosuppressive cytotoxic chemotherapy in the absence of rapidly progressing disease
- At least 48 hours since prior hydroxyurea
Endocrine therapy
- Not specified
Radiotherapy
- Prior radiotherapy allowed
Surgery
- Not specified
Other
- No other concurrent standard or investigational treatment for leukemia
- No concurrent disulfiram
Location Information
Mario Sznol, MD, Study Chair, Vion Pharmaceuticals
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: November 2003
Last Updated: October 13, 2004
Record first received: November 12, 2002
ClinicalTrials.gov Identifier: NCT00049686
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Acute Lymphoblastic Leukemia in Children (National Cancer Institute)
- Acute Lymphoblastic Leukemia in Children (National Cancer Institute)

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