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Keep this study
Lead
Vion Pharmaceuticals
OBJECTIVES:
* Determine the overall response rate (partial and complete) in patients with relapsed or refractory locally advanced or metastatic small cell lung cancer treated with VNP40101M.
* Determine the toxic effects of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to disease state (sensitive relapse \[progressive disease \> 3 months after responding to first-line chemotherapy\] vs resistant disease \[progressive disease during or ≤ 3 months after first-line chemotherapy\]).
Patients receive VNP40101M IV over 15-30 minutes once weekly for 3 weeks. Treatment repeats every 6 weeks for up to 6 courses. Patients achieving a complete response (CR) receive 2 additional courses of therapy after CR.
After completion of study treatment, patients are followed periodically for up to 18 months.
PROJECTED ACCRUAL: A total of 87 patients will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
DISEASE CHARACTERISTICS:
Cytologically confirmed small cell lung cancer
* Locally advanced or metastatic disease
* Recurrent or progressive disease after first-line standard cytotoxic therapy
Measurable or evaluable disease
Brain metastasis allowed
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
Life expectancy ≥ 2 months
Granulocyte count ≥ 1,500/mm\^3
Platelet count ≥ 100,000/mm\^3
Creatinine ≤ 2.0 mg/dL
Bilirubin ≤ 2.5 mg/dL
AST and ALT ≤ 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No active uncontrolled bleeding
No active infection
Must not require supplemental oxygen at rest
No active heart disease
No myocardial infarction within the past 3 months
No uncontrolled congestive heart failure
No uncontrolled arrhythmias
No uncontrolled coronary artery disease
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
More than 3 weeks since prior radiotherapy, biologic therapy or chemotherapy (6 weeks for nitrosoureas or mitomycin C)
* Prior radiotherapy within the past 3 weeks allowed if exposure involves no more than 30% of bones with significant bone marrow-producing capabilities (e.g., vertebral bodies and long bones)
At least 2 weeks since prior surgery or hormonal therapy
Must not require any immediate palliative treatment including surgery