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MLN2704 in Subjects With Metastatic Androgen-Independent Prostate Cancer
This study has been completed.
First Received: October 8, 2003   Last Updated: July 12, 2007   History of Changes
Sponsored by: Millennium Pharmaceuticals, Inc.
Information provided by: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00070837
  Purpose

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.


Condition Intervention Phase
Prostatic Neoplasms
Drug: MLN2704 (DM1 conjugated monoclonal antibody MLN591)
Phase I
Phase II

Genetics Home Reference related topics: myotonic dystrophy
MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Immunoglobulins MLN 2704 Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title: 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

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

Estimated Enrollment: 46
Study Start Date: October 2003
Estimated Study Completion Date: October 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00070837

Locations
United States, New York
Weill Medical College of Cornell University/ New York Presbyterian Hospital
New York, New York, United States, 10021
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, North Carolina
Duke University Medical Center, Box 3532
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic, Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
  More Information

No publications provided

Study ID Numbers: M59102-051
Study First Received: October 8, 2003
Last Updated: July 12, 2007
ClinicalTrials.gov Identifier: NCT00070837     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Genital Neoplasms, Male
Prostatic Diseases
Immunologic Factors
Urogenital Neoplasms
Genital Diseases, Male
Antibodies, Monoclonal
Antibodies
Myotonic Dystrophy
Prostatic Neoplasms
Myotonic Dystrophy 1
Myotonia Atrophica
Immunoglobulins
Androgens

Additional relevant MeSH terms:
Antibodies, Monoclonal
Antibodies
Neoplasms
Neoplasms by Site
Immunologic Factors
Prostatic Diseases
Genital Neoplasms, Male
Physiological Effects of Drugs
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009