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Tracking Information | |||||
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First Received Date ICMJE | April 7, 2003 | ||||
Last Updated Date | February 6, 2009 | ||||
Start Date ICMJE | October 2002 | ||||
Current Primary Outcome Measures ICMJE | |||||
Original Primary Outcome Measures ICMJE | |||||
Change History | Complete list of historical versions of study NCT00058409 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | MLN2704 in Treating Patients With Progressive Metastatic Prostate Cancer | ||||
Official Title ICMJE | A Phase I Single Ascending Dose Trial of MLN2704 (DM1 Conjugated Monoclonal Antibody MLN591) in Subjects With Metastatic Androgen Independent Prostate Cancer | ||||
Brief Summary | RATIONALE: Monoclonal antibodies such as MLN2704 can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effect of MLN2704 on the body in treating patients who have progressive metastatic prostate cancer. |
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Detailed Description | OBJECTIVES:
OUTLINE: This is an open-label, dose-escalation, multicenter study. Patients receive MLN2704 IV over 2.5 hours on day 1. Treatment repeats every 6-8 weeks for up to 3 doses in the absence of disease progression or unacceptable toxicity. Patients with responsive disease after 3 doses of therapy may receive additional therapy as above at the investigator's discretion. Cohorts of 3-6 patients receive escalating doses of MLN2704 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 months until disease progression. PROJECTED ACCRUAL: A maximum of 36 patients will be accrued for this study within 1 year. |
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Study Phase | Phase I | ||||
Study Type ICMJE | Interventional | ||||
Study Design ICMJE | Treatment, Open Label | ||||
Condition ICMJE | Prostate Cancer | ||||
Intervention ICMJE | Biological: MLN2704 | ||||
Study Arms / Comparison Groups | |||||
Publications * | Galsky MD, Eisenberger M, Moore-Cooper S, Kelly WK, Slovin SF, DeLaCruz A, Lee Y, Webb IJ, Scher HI. Phase I trial of the prostate-specific membrane antigen-directed immunoconjugate MLN2704 in patients with progressive metastatic castration-resistant prostate cancer. J Clin Oncol. 2008 May 1;26(13):2147-54. Epub 2008 Mar 24. | ||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | |||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Male | ||||
Ages | |||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID ICMJE | NCT00058409 | ||||
Responsible Party | |||||
Study ID Numbers ICMJE | CDR0000288829, MSKCC-02099, MILLENNIUM-M59102-042 | ||||
Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | April 2005 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |