A Phase II Trial of Cloretazine™ (VNP40101M) for Patients With Relapsed or Refractory Small Cell Lung Cancer
- Determine the overall response rate (partial and complete) in patients with relapsed or
refractory locally advanced or metastatic small cell lung cancer treated with
- 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
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.
Masking: Open Label, Primary Purpose: Treatment
Overall response rate (complete and partial response)
Bonny L. Johnson, RN, MSN
United States: Food and Drug Administration
|Kimmel Cancer Center at Thomas Jefferson University - Philadelphia||Philadelphia, Pennsylvania 19107|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|Yale Cancer Center||New Haven, Connecticut 06520-8028|
|Albert Einstein Cancer Center at Albert Einstein College of Medicine||Bronx, New York 10461|
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|
|Sarah Cannon Cancer Center at Centennial Medical Center||Nashville, Tennessee 37203|
|Veterans Affairs Medical Center - West Haven||West Haven, Connecticut 06516|
|Helen F. Graham Cancer Center at Christiana Hospital||Newark, Delaware 19718|