PHASE I/II STUDY OF IMMUNIZATION WITH MHC CLASS I MATCHED ALLOGENEIC HUMAN PROSTATIC CARCINOMA CELLS ENGINEERED TO SECRETE INTERLEUKIN-2 AND INTERFERON-GAMMA
aldesleukin
+ gene-modified tumor cell vaccine therapy
+ recombinant interferon gamma
Urogenital Diseases+7
+ Genital Diseases
+ Genital Diseases, Male
Treatment Study
Summary
Study start date: January 1, 1995
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.25 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Memorial Sloan-Kettering Cancer Center
New York, United StatesOpen Memorial Sloan-Kettering Cancer Center in Google Maps