S0916, MLN1202 in Treating Patients With Bone Metastases
|ClinicalTrials.gov Identifier: NCT01015560|
Recruitment Status : Completed
First Posted : November 18, 2009
Results First Posted : May 28, 2014
Last Update Posted : March 25, 2015
RATIONALE: Monoclonal antibodies, such MLN1202, 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 II trial is studying how well MLN1202 works in treating patients with bone metastases.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific||Drug: anti-CCR2 monoclonal antibody MLN1202 Genetic: polymorphism analysis Other: laboratory biomarker analysis||Phase 2|
- To assess the urinary n-telopeptide (uNTX) response to anti-CCR2 monoclonal antibody MLN1202 in patients with bone metastases.
- To assess the feasibility of performing cross-disease site trials within the Southwest Oncology Group.
- To explore the effect of anti-CCR2 monoclonal antibody MLN1202 on markers of tumor cell proliferation, monocytes/macrophage trafficking, and osteoclast maturation.
- To estimate allele frequencies of defined SNPs occurring in the CCL2 and CCR2 genes in these patients.
OUTLINE: This is a multicenter study.
Patients receive anti-CCR2 monoclonal antibody MLN1202 IV over 1 hour on days 1, 15, and 29 in the absence of disease progression or unacceptable toxicity.
Patients undergo urine and blood sample collection at baseline and on days 15, 29, and 43 for correlative biomarker and polymorphism studies.
After completion of study treatment, patients are followed up for ≥ 30 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||S0916, A Phase II, Window Trial of the Anti-CCR2 Antibody MLN1202 in Patients With Bone Metastases|
|Study Start Date :||March 2010|
|Primary Completion Date :||December 2012|
|Study Completion Date :||December 2012|
MLN1202 8mg/kg IV Days 1, 15, 29 given as 1 6 week cycle
|Drug: anti-CCR2 monoclonal antibody MLN1202 Genetic: polymorphism analysis Other: laboratory biomarker analysis|
- uNTX Response Rate at 43 Days [ Time Frame: 43 days ]Urinary n-telopeptide (uNTX) response is defined as a 25% reduction from baseline levels. Patients with missing response data were included as non-responders.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01015560
Show 47 Study Locations
|Principal Investigator:||Kenneth J. Pienta, MD, FACP||University of Michigan Cancer Center|