Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| VION-CLI-039 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
OBJECTIVES:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laromustine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (complete and partial response) | ||
| Toxicity |
Not provided
Not provided
DISEASE CHARACTERISTICS:
Cytologically confirmed small cell lung cancer
Measurable or evaluable disease
Brain metastasis allowed
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
More than 3 weeks since prior radiotherapy, biologic therapy or chemotherapy (6 weeks for nitrosoureas or mitomycin C)
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
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bonny L. Johnson, RN, MSN | Vion Pharmaceuticals |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | 90089-9181 | United States | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Yale Cancer Center |
| New Haven |
| Connecticut |
| 06520-8028 |
| United States |
| Veterans Affairs Medical Center - West Haven | West Haven | Connecticut | 06516 | United States |
| Helen F. Graham Cancer Center at Christiana Hospital | Newark | Delaware | 19713 | United States |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | 19107-5541 | United States |
| Sarah Cannon Cancer Center at Centennial Medical Center | Nashville | Tennessee | 37203 | United States |
| M. D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4009 | United States |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C483604 | laromustine |
Not provided
Not provided
Not provided