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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: laromustine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: laromustine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (complete and partial response) |  |  | 
| Toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent small cell lung cancer, extensive stage small cell lung cancer, limited stage small cell lung cancer