A Phase II Study Of Autologous Tumor/DC Vaccine (DC Vaccine) Combined With Interleukin-2 (IL-2) And Interferon-α-2a (IFNα-2a) In Patients With Metastatic Renal Cell Carcinoma (RCC)
- Determine the clinical response rate in patients with metastatic renal cell carcinoma
treated with autologous dendritic cells (DC) loaded with autologous tumor lysate (DC
vaccine) in combination with interleukin-2 and interferon-alfa.
- Determine the toxicity of this regimen in these patients.
- Determine, within relevant immune pathways, the treatment-related, tumor-specific
immune response in patients treated with this regimen.
- Correlate tumor-specific immune response with objective clinical response in patients
treated with this regimen.
- Induction therapy: Patients undergo leukapheresis on day -9. Patients receive
autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vaccine) by
intranodal injection on days 0 and 14; interleukin-2 (IL-2) IV continuously on days 1-5
and 15-19; and interferon-alfa (IFN-α) subcutaneously (SC) once daily on days 1, 3, 5,
15, 17, and 19.
- Maintenance therapy: Patients undergo leukapheresis on days 33, 61, and 89. Patients
receive DC vaccine by intranodal injection on days 42, 70, and 98; IL-2 IV continuously
on days 43-47, 71-75, and 99-103; and IFN-α SC once daily on days 43, 45, 47, 71, 73,
75, 99, 101, and 103.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 18-33 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical Response as Measured by RECIST Monthly and Then Every 2-3 Months
A total of 18 evaluable patients will be accrued in the first stage. If 4 or fewer responses are observed in the first stage, the trial will be stopped early, otherwise an additional 15 evaluable patients will be accrued for a total of 33 evaluable patients. If 11 or more responses are observed among the 33 patients, the experimental regimen will be considered for further study, otherwise it will be rejected. The trial will not proceed to the second stage unless at least 5 responses are observed in the first stage.
If 4 or fewer responses are observed in the first stage, the trial will be stopped
Marc S. Ernstoff, MD
Norris Cotton Cancer Center
United States: Federal Government
|Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center||Lebanon, New Hampshire 03756-0002|