MLN2704 in Subjects With Metastatic Androgen-Independent Prostate Cancer

July 12, 2007 updated by: Millennium Pharmaceuticals, Inc.

A Phase 1/2 Dose Escalation Trial of Multiple Doses of MLN2704 (DM1 Conjugated Monoclonal Antibody MLN591) in Subjects With Metastatic Androgen-Independent Prostate Cancer

The purpose of the study is to determine the highest dose of MLN2704 that can be given multiple times safely to patients with prostate cancer, and to identify any side effects associated with taking the drug. This study will also evaluate how MLN2704 is taken up, broken down and eliminated by the body.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment

46

Phase

  • Phase 2
  • 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 Locations

    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10021
        • Weill Medical College of Cornell University/ New York Presbyterian Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center, Box 3532
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic, Taussig 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

Inclusion Criteria:

  • Histologic or cytologic diagnosis (recent or remote) of prostate adenocarcinoma
  • Radiographic evidence (recent or remote) of metastatic prostate adenocarcinoma
  • 18 years of age or older
  • Progressive prostate cancer as defined by the presence of one or more of the following despite castrate levels of testosterone (testosterone <50 ng/dL):

    1. Progressive tumor lesions (changes in the size of lymph nodes or parenchymal masses on physical examination or X-ray and CT scan or MRI)
    2. Progressive bone metastasis (presence of new lesion(s) on a bone scan)
    3. Progressive PSA levels (as defined in Section 3.6.1)
  • Subjects who have received an anti-androgen must have shown progression of disease following discontinuation of the anti-androgen
  • Subjects must remain on luteinizing hormone-releasing hormone (LHRH) analog therapy for the duration of the trial unless surgically castrate
  • Agree to use an effective barrier method of contraception.

Exclusion criteria:

  • Testosterone >50 ng/dL
  • Use of corticosteroids and/or adrenal hormone inhibitors within 4 weeks of dosing
  • Use of PC-SPES within 4 weeks of dosing
  • Prior cytotoxic chemotherapy and/or radiation therapy within 6 weeks of dosing
  • Use of anti-androgen therapy (eg, flutamide, bicalutamide, nilutamide) within 6 weeks of dosing
  • Prior monoclonal antibody administration, including Prostascint®
  • Peripheral neuropathy of > Grade 2, as defined by the NCI Common Toxicity Criteria for Adverse Events (NCI CTCAE)
  • History of CNS metastasis, including incompletely treated epidural disease
  • History of Hepatitis B or C
  • History of seizure disorder requiring active treatment and/or stroke
  • History of HIV infection
  • Platelet count <100,000/mm3
  • Absolute neutrophil count (ANC) <1,500/mm3
  • Hematocrit <27 percent
  • Abnormal coagulation profile (elevated PT, and/or INR, PTT)
  • Serum creatinine >2.0 mg/dL, or creatinine clearance <60 mL/min if serum creatinine >2.0 mg/dL
  • AST or ALT >1.5 x ULN
  • Bilirubin (total) >1.25 x ULN
  • Serum calcium >12.5 mg/dL
  • Active serious infection not controlled by antibiotics
  • Active angina pectoris or NY Heart Association Class III-IV heart disease
  • Karnofsky Performance Status <60%
  • Life expectancy <6 months
  • Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems that might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study.

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: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

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

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

October 1, 2003

Study Completion

October 1, 2004

Study Registration Dates

First Submitted

October 8, 2003

First Submitted That Met QC Criteria

October 10, 2003

First Posted (Estimate)

October 13, 2003

Study Record Updates

Last Update Posted (Estimate)

July 13, 2007

Last Update Submitted That Met QC Criteria

July 12, 2007

Last Verified

July 1, 2007

More Information

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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