Safety Study of a Radiolabeled Antibody (7E11) in Patients With Progressive Hormone Refractory Prostate Cancer (CYT-500)

September 6, 2007 updated by: Cytogen Corporation

A Phase 1 Study of Radiolabeled Monoclonal Antibody 7E11-C5.3(177Lu-meO-DOTA-7E11;CYT-500) in Patients With Progressive Androgen-Independent Prostate Cancer

The proposed phase 1 clinical trial will investigate the safety and tolerability of 177Lu-CYT-500 in patients with metastatic prostate cancer and determine the optimal antibody mass and dose of 177Lu to be used for further study.

Study Overview

Status

Status

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

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

The proposed phase I clinical trial will investigate the safety and tolerability of 177Lu-CYT-500 and determine the optimal antibody mass and dose of 177Lu to be used for further study. The biodistribution and pharmacokinetics will also be assessed. Patients with histologically documented prostate cancer that is progressing following castration will be eligible. Two antibody masses will be explored in cohort 1 before dose escalation of the 177Lu begins. If the two antibody masses show no difference in pharmacokinetics or biodistribution, then the lower of the doses will be used. The radiation dose will be escalated in subsequent cohorts. Dose escalation will be permitted when the last patient accrued to the previous cohort has demonstrated count recovery in cycle 1 such that DLT has not been defined.

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

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

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 1

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

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

Inclusion Criteria:

  • Histologically documented prostate cancer that is progressing following castration. The disease should not be progressing so as to require palliative treatment within 12 weeks of enrollment based on clinical assessment by the investigator. All patients must have assessable disease by radionuclide and/or radiographic studies.
  • Castrate levels of testosterone (<50 ng/ml).
  • Karnofsky performance status >60%.
  • Patients whose initial hormone treatment (exclusive of neoadjuvant hormone therapy) was a combined androgen blockade approach, e.g. an orchiectomy plus an anti-androgen, or gonadotropin releasing hormone analog and an anti-androgen, must show progression of disease following withdrawal of the anti-androgen prior to enrollment.

  • Adequate organ function:

    • Hematologic:

      • ANC >1,500/mm3
      • Platelet count >100,000/mm3
    • Hepatic: Bilirubin <1.5 mg/dL and AST<1.5X's the ULN
    • Renal: Creatinine <1.5 mg/dL or creatinine clearance > 60 mL/min.
    • Coagulation: Prothrombin time < institutional UNL.
  • Patients must have recovered from the acute toxicities of any prior therapy, and not received chemotherapy, radiation therapy or other investigational anticancer therapeutic drugs for at least 4 weeks prior to entry into the trial.
  • Patients must be at least 18 years of age.
  • Subjects will be informed as to the potential risk of procreation while participating in this trial and will be advised to use effective contraception during the entire study period.
  • Patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the institution.

Exclusion Criteria:

  • Clinically significant cardiac disease (New York Heart Association Class III or IV), or severe debilitating pulmonary disease.
  • Active CNS or epidural primary tumor or active CNS or epidural metastases.
  • An active uncontrolled infection or an infection requiring intravenous antibiotic treatment.
  • Participation in another therapeutic clinical trial with an experimental drug, concurrently or within the 4 weeks prior to dosing in this study.
  • Lack of recovery from the myelosuppressive effects of prior radiation therapy or chemotherapy.
  • Patients who have undergone diagnostic ProstaScint, Myoscint, or Oncoscint scans, or have undergone any other prior administration of a murine protein for diagnostic or therapeutic purposes, without regard to HAMA test results.
  • Patients with a history of autoimmune hepatitis or history of autoimmune disease.
  • Prior radiation therapy encompassing >25% of the bone marrow
  • Prior systemic administration of a therapeutic radiolabeled monoclonal antibody.
  • Patients who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse, while taking the drug and for 4 weeks after stopping treatment.

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
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
To investigate the safety and tolerability of treatment with 177Lu-CYT-500 in patients with progressive androgen-independent prostate cancer
To determine the optimal antibody mass and dose of 177Lu-CYT-500 to be used for further study.
To determine the biodistribution and pharmacokinetics of 177Lu-CYT-500

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
To determine the rate of HAMA induction as a result of treatment with 177Lu-CYT-500

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.
Cytogen Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael J Morris, M.D., Memorial Sloan Kettering Cancer Center

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.
February 1, 2007

Primary Completion

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.
December 7, 2022

Study Completion

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.
December 7, 2022

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).
February 27, 2007

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.
February 28, 2007

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.
March 1, 2007

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.
September 10, 2007

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.
September 6, 2007

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.
September 1, 2007

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.
  • 500Lu01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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