RATIONALE: Interleukin-2 may stimulate a person's white blood cells including natural killer
cells to kill prostate cancer cells. Interferon gamma may interfere with the growth of the
cancer cells. Combining interferon gamma with interleukin-2 may be a more effective
treatment for prostate cancer.
PURPOSE: Phase I/II trial to study the effectiveness of biological therapy using
interleukin-2 and interferon gamma in treating patients with advanced prostate cancer.
OBJECTIVES: I. Evaluate the safety of immunization with HLA class I-matched allogeneic human
prostate carcinoma cells genetically engineered to secrete interleukin-2 and interferon
gamma in patients with prostate carcinoma. II. Evaluate the antitumor effects of this
treatment as assessed by post-therapy declines in PSA. III. Evaluate the induction of
cellular and humoral immunity in vivo with this treatment.
OUTLINE: Tumor Cell Vaccine Therapy. Immunization with irradiated, MHC class I-matched
allogeneic human prostate carcinoma cells, LNCaP cells, engineered to secrete approximately
58 ng/24 hr/million cells of interleukin-2 (IL-2) and approximately 0.72 U/24 hr/million
cells of interferon gamma (IFN-G).
PROJECTED ACCRUAL: Up to 12 patients will be entered on the Phase I study; accrual will
continue to a total of 25 patients treated at the MTD (Phase II). Accrual is expected to
require 2 years.
DISEASE CHARACTERISTICS: Histologically confirmed prostate carcinoma For Phase I:
progressive, androgen-independent disease required, i.e.: Elevated PSA despite castrate
testosterone levels (below 50 ng/dl) documented on 3 successive occasions For Phase II:
progressive disease after surgery or radiotherapy without prior hormonal therapy also
eligible HLA-A1- or HLA-A2-positive disease required Measurable or evaluable disease
required No active CNS metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: At least 12 weeks Hematopoietic: WBC greater than 3,000 Absolute lymphocytes
greater than 1,000 Platelets greater than 100,000 Hb at least 9 g/dl Hepatic: Bilirubin
less than 2.0 mg/dl OR SGOT less than 2 x ULN Renal: Creatinine no greater than 2.0 mg/dl
OR Creatinine clearance at least 40 ml/min Cardiovascular: No NYHA class III/IV status
Pulmonary: No severe debilitating pulmonary disease Other: No active infection requiring
antibiotics Not HIV positive No history of hypersensitivity to interferon gamma or other
vaccine component No serious intercurrent medical illness
PRIOR CONCURRENT THERAPY: Recovered from toxicity of any prior therapy Biologic therapy:
No prior autologous or allogeneic tumor vaccines No concurrent other immunotherapy
Chemotherapy: At least 4 weeks since chemotherapy No concurrent chemotherapy Endocrine
therapy: Flutamide discontinued and subsequent progression prior to entry 3 consecutive
rising PSA values at least 2 weeks apart No concurrent corticosteroids (except for
life-threatening conditions) Medical hormonal therapy to maintain castrate testosterone
levels required in the absence of orchiectomy Radiotherapy: At least 4 weeks since
radiotherapy No concurrent radiotherapy Surgery: Prior surgery allowed