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A Trial of MLN2704 in Subjects With Metastatic Androgen Independent Prostate Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00052000
First Posted: January 22, 2003
Last Update Posted: March 1, 2007
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.
Information provided by:
Millennium Pharmaceuticals, Inc.
  Purpose
This is the first study of MLN2704 administered to humans. The purpose of the study is to determine the highest dose of MLN2704 that can be given 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 (absorbed), broken down (metabolized) and eliminated (excreted) by the body. This process is called pharmacokinetic analysis.

Condition Intervention Phase
Prostate Cancer Drug: MLN2704 (DM1 conjugated monoclonal antibody MLN591) Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Single Ascending Dose Trial of MLN2704 (DM1 Conjugated Monoclonal Antibody MLN591) in Subjects With Metastatic Androgen Independent Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Estimated Enrollment: 29
Study Start Date: November 2002
Detailed Description:
This is a Phase 1 open-label dose-escalating trial designed to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and pharmacokinetics of a single dose of MLN2704 in subjects with metastatic androgen-independent prostate cancer.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Each subject must meet the following inclusion criteria to be eligible for enrollment in the study:

  • Histologic diagnosis (recent or remote) of prostate adenocarcinoma
  • Progressive prostate cancer on physical exam, imaging studies and/or rising PSA, as defined by the presence of one or more of the following:

    • Progressive tumor lesions (changes in the size of lymph nodes or parenchymal masses on physical examination or X-ray and CT scan or MRI)
    • Progressive bone metastasis (presence of new lesion(s) on a bone scan)
    • Progressive PSA levels despite castrate levels of testosterone
    • Patients who have received an anti-androgen must have shown progression of disease off of the anti-androgen prior to enrollment
  • Failed hormonal therapy (including anti-androgen withdrawal therapy, as appropriate)
  • LHRH (Luteinizing Hormone–Releasing Hormone)analog therapy:
  • If subject is being treated with LHRH analog therapy at the time of screening the therapy must be maintained for the duration of the trial.
  • If subject discontinued LHRH therapy prior to screening, the therapy must be discontinued ≥10 weeks prior to enrollment for 1 month depot preparations, 24 weeks for 3 month depot preparations, and 32 weeks for 4 month depot preparations.
  • Agree to use an effective method of barrier contraception. Effective method of barrier contraception includes a condom with spermicidal jelly, a diaphragm with spermicidal jelly, or abstinence.

Exclusion Criteria

Subjects meeting any of the following exclusion criteria are not to be enrolled in the study:

  • Use of corticosteroids and/or adrenal hormone inhibitors within 4 weeks of enrollment
  • Use of PC-SPES (herbal supplement) within 4 weeks of enrollment
  • Prior cytotoxic chemotherapy and/or radiation therapy within 6 weeks of enrollment
  • Use of anti-androgen therapy (e.g., flutamide, bicalutamide, nilutamide) within 6 weeks of enrollment
  • Prior monoclonal antibody administration, including Prostacint®
  • Peripheral neuropathy of Grade 2 or greater intensity, as defined by the NCI Common Toxicity Criteria (NCI CTC)
  • History of CNS metastasis, including epidural disease
  • 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 ≤30 percent
  • Abnormal coagulation profile (PT, and/or INR, PTT)
  • Creatinine clearance <60 mL/min or Serum creatinine >2.0 mg/dL
  • AST or ALT >1.5 X ULN
  • Bilirubin (total) >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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00052000


Locations
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center @ Johns Hopkins
Baltimore, Maryland, United States, 21231
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
  More Information

ClinicalTrials.gov Identifier: NCT00052000     History of Changes
Obsolete Identifiers: NCT00058409
Other Study ID Numbers: M59102-042
First Submitted: January 21, 2003
First Posted: January 22, 2003
Last Update Posted: March 1, 2007
Last Verified: February 2007

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Androgens
Immunologic Factors
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists