MLN2704 in Treating Patients With Progressive Metastatic Prostate Cancer
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|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|
- Determine the dose-limiting toxicity and maximum tolerated dose of MLN2704 immunoconjugate in patients with progressive metastatic androgen-independent prostate cancer.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the prostate-specific antigen and disease response in patients treated with this drug.
- Determine the anti-MLN591 antibody and anti-MLN2704 antibody response to this drug in these patients.
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.
|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|