A Phase II Trial of Cloretazine™ (VNP40101M) for Patients With Relapsed or Refractory Small Cell Lung Cancer
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Overall response rate (complete and partial response)
No
Bonny L. Johnson, RN, MSN
Vion Pharmaceuticals
United States: Food and Drug Administration
CDR0000456623
NCT00282022
September 2005
Name | Location |
---|---|
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 |