MLN2704 in Subjects With Metastatic Androgen-Independent Prostate Cancer - Full Text View

Sponsor:	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

Millennium Pharmaceuticals, Inc. has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Immunoglobulins MLN 2704 Globulin, Immune

U.S. FDA Resources

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

ClinicalTrials.gov Identifier:	NCT00070837 History of Changes
Obsolete Identifiers:	NCT00074347
Other Study ID Numbers:	M59102-051
Study First Received:	October 8, 2003
Last Updated:	July 12, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Androgens

Antibodies
Antibodies, Monoclonal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Immunologic Factors

ClinicalTrials.gov processed this record on February 12, 2012