Biological Therapy in Treating Patients With Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00002637
First received: November 1, 1999
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Biological: aldesleukin
Biological: gene-modified tumor cell vaccine therapy
Biological: recombinant interferon gamma
Phase 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Estimated Enrollment: 25
Study Start Date: January 1995
Study Completion Date: February 2001
Primary Completion Date: February 2001 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002637

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Susan Slovin, MD, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002637     History of Changes
Other Study ID Numbers: 94-134, CDR0000064100, NCI-V95-0629
Study First Received: November 1, 1999
Last Updated: June 24, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Interferon-gamma
Interferons
Aldesleukin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on April 17, 2014