Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer

June 17, 2013 updated by: Memorial Sloan Kettering Cancer Center

Pilot Trial of Humanized Monoclonal Antibody J591 in Patients With Progressive Androgen-Independent Prostate Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • 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

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • 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

Renal:

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

Cardiovascular:

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

Pulmonary:

  • No severe debilitating pulmonary disease

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

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

Endocrine therapy:

  • See Disease Characteristics
  • No concurrent anticancer hormonal therapy

Radiotherapy:

  • 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

Surgery:

  • See Disease Characteristics
  • No concurrent surgery

Other:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Primary Completion (Actual)

February 1, 2004

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

September 13, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

June 18, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSKCC-01030
  • CDR0000068903 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-G01-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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