VNP40101M in Treating Patients With Relapsed or Refractory Locally Advanced or Metastatic Small Cell Lung Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: laromustine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Cloretazine™ (VNP40101M) for Patients With Relapsed or Refractory Small Cell Lung Cancer |
- Overall response rate (complete and partial response) [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 87 |
| Study Start Date: | September 2005 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90089-9181 | |
| United States, Connecticut | |
| Yale Cancer Center | |
| New Haven, Connecticut, United States, 06520-8028 | |
| Veterans Affairs Medical Center - West Haven | |
| West Haven, Connecticut, United States, 06516 | |
| United States, Delaware | |
| Helen F. Graham Cancer Center at Christiana Hospital | |
| Newark, Delaware, United States, 19713 | |
| United States, New York | |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | |
| Bronx, New York, United States, 10461 | |
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19107-5541 | |
| United States, Tennessee | |
| Sarah Cannon Cancer Center at Centennial Medical Center | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| Investigator: | Bonny L. Johnson, RN, MSN | Vion Pharmaceuticals |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00282022 History of Changes |
| Other Study ID Numbers: | CDR0000456623, VION-CLI-039 |
| Study First Received: | January 24, 2006 |
| Last Updated: | January 7, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Cancer Institute (NCI):
|
recurrent small cell lung cancer extensive stage small cell lung cancer limited stage small cell lung cancer |
Additional relevant MeSH terms:
|
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
ClinicalTrials.gov processed this record on May 22, 2013