A Phase I/II Trial of Vaccination With Mutant Ras Peptide-Pulsed Dendritic Cells in the Treatment of HLA A2.1 Positive Patients With Colorectal Cancer
- Determine the frequency of immunologic response in patients with locally advanced or
metastatic colorectal cancer treated with ras peptide-pulsed dendritic cell vaccine
with or without interleukin-2.
- Determine the tumor response and survival time in patients with metastatic colorectal
cancer treated with vaccine plus interleukin-2.
- Determine the time to progression in patients with locally advanced colorectal cancer
treated with adjuvant vaccine.
OUTLINE: Patients are assigned to 1 of 2 treatment groups according to extent of disease.
Patients with prior locally advanced disease are assigned to treatment group A, while those
with metastatic disease are assigned to treatment group B.
- Group A: Patients are vaccinated against influenza on day -6. Patients undergo
collection of peripheral blood mononuclear cells (PBMC) on day -4. The PBMC are
cultured with sargramostim (GM-CSF) and interleukin-4 for 5 days and CD40 ligand for 24
hours and then pulsed for 2 hours with the appropriate peptide to form a vaccine.
Patients receive ras peptide-pulsed dendritic cell vaccine IV over 5 minutes on days 1,
15, 29, 43, and 57.
- Group B: Patients undergo collection of PBMC and receive vaccination as in group A.
Patients also receive interleukin-2 subcutaneously on days 2-6 and 9-13.
Treatment in both groups repeats every 2 weeks for up to 5 vaccinations in the absence of
disease progression or unacceptable toxicity.
Patients are followed on days 75, 90, 120, and 365.
PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study within 3 years.
Primary Purpose: Treatment
Response rate every 3 months for up to a year after completion of study treatment
John E. Janik, MD
NCI - Metabolism Branch;MET
United States: Federal Government
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|