Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00024232
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 18, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Brief Summary:

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have prostate cancer that has not responded to hormone therapy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: monoclonal antibody huJ591 Phase 2

Detailed Description:


  • Determine the antitumor effects of monoclonal antibody huJ591 in patients with progressive androgen-independent prostate cancer.
  • Determine the biodistribution and dosimetry of this antibody in these patients.
  • Determine the effect on biodistribution of the delivery sequence of unlabeled vs indium In 111-labeled antibody in these patients.
  • Determine the HAHA response in patients treated with this regimen.
  • Correlate the dose of monoclonal antibody huJ591 with antibody-dependent cellular cytotoxicity in these patients.

OUTLINE: Patients are assigned to one of two treatment groups.

  • Group I: Patients receive monoclonal antibody huJ591 IV followed by indium In 111 monoclonal antibody huJ591 on day 1.
  • Group II: Patients receive monoclonal antibody huJ591 concurrently with indium In 111 monoclonal antibody huJ591 as in group I.

Treatment in both groups repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed for 4 weeks and then monthly for 3 months.

PROJECTED ACCRUAL: A total of 14 patients (7 per treatment group) will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Pilot Trial of Humanized Monoclonal Antibody J591 in Patients With Progressive Androgen-Independent Prostate Cancer
Study Start Date : June 2001
Actual Primary Completion Date : February 2004
Actual Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed prostate cancer
  • Disease progression after prior castration

    • At least 3 rising PSA levels at least 1 week apart OR 2 rising levels at least 4 weeks apart
  • New osseous lesions on bone scan and/or more than 25% increase in bidimensionally measurable soft tissue disease or appearance of new sites of disease by CT scan or MRI
  • Testosterone no greater than 50 ng/mL

    • Medical therapy (e.g., gonadotropin-releasing hormone analogues) to maintain castrate level of testosterone should continue in the absence of surgical orchiectomy
  • Progression of disease after discontinuation of prior anti-androgen therapy
  • No requirement for palliative therapy within the past 12 weeks
  • No active CNS or epidural primary tumor OR active CNS or epidural metastases



  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified


  • WBC greater than 3,500/mm3
  • Platelet count greater than 100,000/mm3


  • Bilirubin less than 1.5 mg/dL
  • Gamma-glutamyl-transferase less than upper limit of normal (ULN)
  • AST less than ULN
  • PT less than 14 seconds
  • No prior autoimmune hepatitis


  • Creatinine less than 1.5 mg/dL OR
  • Creatinine clearance greater than 60 mL/min


  • No clinically significant cardiac disease (New York Heart Association class III or IV)


  • No severe debilitating pulmonary disease


  • Fertile patients must use effective contraception
  • No active uncontrolled infection or infection requiring IV antibiotics
  • No prior autoimmune disease


Biologic therapy:

  • No prior murine protein for diagnostic or therapeutic purposes
  • No other concurrent anticancer immunotherapy


  • At least 4 weeks since prior chemotherapy and recovered
  • No concurrent anticancer chemotherapy

Endocrine therapy:

  • See Disease Characteristics
  • No concurrent anticancer hormonal therapy


  • At least 4 weeks since prior radiotherapy and recovered
  • Concurrent radiotherapy to localized sites of disease (e.g., bone) allowed if the site does not contain sole measurable lesion


  • See Disease Characteristics
  • No concurrent surgery


  • Recovered from all prior therapy
  • At least 4 weeks since prior therapeutic investigational anticancer drugs
  • At least 4 weeks since prior participation in therapeutic clinical trial with an experimental drug
  • No prior diagnostic ProstaScint, Myoscint, or Oncoscint scans
  • No other concurrent therapeutic investigational anticancer agents
  • No concurrent participation in other therapeutic clinical trial with an experimental drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00024232

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Michael Morris, MD Memorial Sloan Kettering Cancer Center Identifier: NCT00024232     History of Changes
Other Study ID Numbers: MSKCC-01030
CDR0000068903 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 18, 2013
Last Verified: June 2013

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs