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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00058409 |
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.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: MLN2704 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I Single Ascending Dose Trial of MLN2704 (DM1 Conjugated Monoclonal Antibody MLN591) in Subjects With Metastatic Androgen Independent Prostate Cancer |
Study Start Date: | October 2002 |
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.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed prostate adenocarcinoma
Progressive disease by physical exam, imaging studies, and/or rising prostate-specific antigen (PSA) levels defined by at least 1 of the following criteria*:
Progressive PSA levels despite castrate levels of testosterone
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Luteinizing hormone-releasing hormone (LHRH) analog therapy allowed if 1 of the following circumstances exists:
Radiotherapy
Surgery
Other
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Howard I. Scher, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000288829, MSKCC-02099, MILLENNIUM-M59102-042 |
Study First Received: | April 7, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00058409 |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer |
Genital Neoplasms, Male Prostatic Diseases Urogenital Neoplasms Genital Diseases, Male Dystrophia myotonica 1 Recurrence Antibodies, Monoclonal |
Myotonia atrophica Antibodies Myotonic Dystrophy Adenocarcinoma Prostatic Neoplasms Immunoglobulins |
Neoplasms Neoplasms by Site |