- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00282022
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
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.
Study Overview
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90089-9181
- USC/Norris Comprehensive Cancer Center and Hospital
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Connecticut
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New Haven, Connecticut, United States, 06520-8028
- Yale Cancer Center
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West Haven, Connecticut, United States, 06516
- Veterans Affairs Medical Center - West Haven
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Delaware
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Newark, Delaware, United States, 19713
- Helen F. Graham Cancer Center at Christiana Hospital
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New York
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Bronx, New York, United States, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Taussig Cancer Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107-5541
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
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Tennessee
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Nashville, Tennessee, United States, 37203
- Sarah Cannon Cancer Center at Centennial Medical Center
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Texas
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Houston, Texas, United States, 77030-4009
- M. D. Anderson Cancer Center at University of Texas
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Toxicity
|
Overall response rate (complete and partial response)
|
Collaborators and Investigators
Sponsor
Investigators
- Bonny L. Johnson, RN, MSN, Vion Pharmaceuticals
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000456623
- VION-CLI-039
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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