VNP40101M in Treating Patients With Relapsed or Refractory Locally Advanced or Metastatic Small Cell Lung Cancer
NCT ID: NCT00282022
Last Updated: 2013-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
87 participants
INTERVENTIONAL
2005-09-30
Brief Summary
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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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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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laromustine
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Vion Pharmaceuticals
INDUSTRY
Principal Investigators
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Bonny L. Johnson, RN, MSN
Role:
Vion Pharmaceuticals
Locations
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USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
Veterans Affairs Medical Center - West Haven
West Haven, Connecticut, United States
Helen F. Graham Cancer Center at Christiana Hospital
Newark, Delaware, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
The Bronx, New York, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Sarah Cannon Cancer Center at Centennial Medical Center
Nashville, Tennessee, United States
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Countries
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Other Identifiers
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VION-CLI-039
Identifier Type: -
Identifier Source: secondary_id
CDR0000456623
Identifier Type: -
Identifier Source: org_study_id