VNP40101M in Treating Patients With Relapsed or Refractory Locally Advanced or Metastatic Small Cell Lung Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as VNP40101M, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well VNP40101M works in treating patients with recurrent or refractory locally advanced or metastatic small cell lung cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vion Pharmaceuticals

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