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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Susan Slovin, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

94-134

NCT ID:

NCT00002637

Start Date:

January 1995

Completion Date:

February 2001

Related Keywords:

  • Prostate Cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021