Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Biological Therapy in Treating Patients With Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Completed	18 and over	Other	MSKCC-94134 NCI-V95-0629, NCT00002637

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.

Entry 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

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

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

Expected Enrollment

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.

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).

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Susan Slovin, MD, PhD, Protocol chair		Ph: 646-422-4470; 800-525-2225

Registry Information
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
Trial Start Date		1995-01-10
Registered in ClinicalTrials.gov		NCT00002637
Date Submitted to PDQ		1995-01-10
Information Last Verified		2008-12-23
NCI Grant/Contract Number		P30-CA08748

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