Maytansinoid DM4-Conjugated Humanized Monoclonal Antibody huC242 in Treating Patients With Solid Tumors
RATIONALE: Monoclonal antibodies, such as maytansinoid DM4-conjugated humanized monoclonal antibody huC242, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This phase I trial is studying the side effects and best dose of maytansinoid DM4-conjugated humanized monoclonal antibody huC242 in treating patients with solid tumors that cannot be removed by surgery or have spread to other parts of the body.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase I Study to Assess the Safety and Pharmacokinetics of huC242-DM4 Administered as a Single Intravenous Infusion Once Every Three Weeks to Subjects With Solid Tumors|
- Dose-limiting toxicity [ Time Frame: for the duration of the trial ]
- Maximum tolerated dose [ Time Frame: for the duration of the trial ]
- Toxicity [ Time Frame: for the duration of the trial ]
- Pharmacokinetics [ Time Frame: for the duration of the trial ]
- Antitumor activity [ Time Frame: for the duration of the trial ]
|Study Start Date:||February 2005|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
- Determine the dose-limiting toxicity and maximum tolerated dose of maytansinoid DM4-conjugated humanized monoclonal antibody huC242 in patients with inoperable or metastatic colorectal cancer, pancreatic cancer, or other solid tumors.
- Determine the qualitative and quantitative toxicities of this drug in these patients.
- Characterize the pharmacokinetics of this drug in these patients.
- Describe any antitumor activity of this drug in these patients.
OUTLINE: This is an open-label, nonrandomized, dose-escalation study.
Patients receive maytansinoid DM4-conjugated humanized monoclonal antibody huC242 IV over 4-5 hours on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of maytansinoid DM4-conjugated humanized monoclonal antibody huC242 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Up to 15 patients are treated at the MTD.
Patients undergo blood collection at baseline and periodically during study for pharmacokinetic studies.
After completion of study treatment, patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00352131
|United States, Texas|
|South Texas Accelerated Research Therapeutics|
|San Antonio, Texas, United States, 78229|
|UT Health Science Center|
|San Antonio, Texas, United States, 78245-3217|
|Study Chair:||Alain Mita, MD||Institute for Drug Development|