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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial Sloan Kettering Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2001

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2001

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2003

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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