Biological Therapy in Treating Patients With Prostate Cancer

Condition(s) targeted: Prostate Cancer

Intervention: aldesleukin (Drug); recombinant interferon gamma (Drug); tumor cell-derivative vaccine therapy (Procedure)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Memorial Sloan-Kettering Cancer Center

Official(s) and/or principal investigator(s):
Susan Slovin, MD, PhD, Study Chair, Affiliation: Memorial Sloan-Kettering Cancer Center

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.

Official title: PHASE I/II STUDY OF IMMUNIZATION WITH MHC CLASS I MATCHED ALLOGENEIC HUMAN PROSTATIC CARCINOMA CELLS ENGINEERED TO SECRETE INTERLEUKIN-2 AND INTERFERON-GAMMA

Study design: Treatment

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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

Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: January 1995
Last updated: May 23, 2008