Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Vion Pharmaceuticals
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
