Clinical trial · Interventional
VNP40101M in Treating Patients With Relapsed or Refractory Locally Advanced or Metastatic Small Cell Lung Cancer
A Phase II Trial of Cloretazine™ (VNP40101M) for Patients With Relapsed or Refractory Small Cell Lung Cancer
NCT00282022CI-TRIAL-00012539completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laromustine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Overall response rate (complete and partial response)
- measure
- Toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.