Vaccine treatment using cultured autologous tumor cells in patients with recurrent, metastatic, or high-risk renal cell carcinoma

1247 Between 1991-2001 we attempted to produce tumor cell lines from patients with advanced kidney cancer [Dillman et al, Cancer Biother Radiopharm 16:47-54, 2001]. Here we report the results from treating 26 kidney cancer patients with their patient-specific whole tumor cell vaccines derived from the short-term autologous tumor cell lines. 100 million cells from successful short-term cell lines were irradiated, frozen in aliquots of 10 7 cells, then thawed and administered s.c. once a week for 3 weeks, then once a month for 5 months. Various adjuvants were co-administered with each vaccine including GM-CSF, interferon-γ, interferon-α, and BCG. Patients included 20 men and 6 women, 43-82 years of age (median 53). At the time of treatment, 17 patients had distant metastatic disease, 3 had regional extension or spread of disease, and 6 had a large primary lesion. Vaccine therapy was well tolerated. Delayed type hypersensitivity (DTH) tests of 10 6 irradiated tumor cells, injected i.d. were positive in only 1/25 at week 0, but converted to positive in 6/19 of the DTH-negative patients who were retested at week-4. The objective response rate in patients who had measurable metastatic disease at the time of treatment was 0/15. With a median follow-up of > 5 years from date of DTH #1, median survival is 3 years, 5-year survival rate is 40%, and 11 patients are alive 3 to 12 years later. The 7 DTH+ patients survived a median of 2.5 years and 3 are still alive after 3, 4, and 7 years. One female patient who had lung, liver, and adrenal metastases had stable disease as her best response, subsequently had disease progression but remains alive more than 5 years later. The other 7 patients who survived more than 5 years had no measurable disease at the time treatment was initiated. This approach is feasible and the therapy is well tolerated; it would probably be best to limit further testing to patients with minimal tumor burdens, such as the adjuvant setting after primary treatment, or in patients with metastatic disease who can be rendered free of disease by surgery or systemic therapy.