A Phase II Trial of Cloretazine™ (VNP40101M) for Patients With Relapsed or Refractory Small Cell Lung Cancer

Inclusion Criteria

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

- Must have recovered from prior anticancer therapy

- Persistent, stable chronic toxic effects ≤ grade 1 are allowed

- No more than 1 prior systemic chemotherapy regimen for locally advanced or metastatic
disease

- No other concurrent anticancer therapy

- No other concurrent investigational agent

- No concurrent disulfiram