S0916, MLN1202 in Treating Patients With Bone Metastases
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.
Unspecified Adult Solid Tumor, Protocol Specific
Drug: anti-CCR2 monoclonal antibody MLN1202
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||S0916, A Phase II, Window Trial of the Anti-CCR2 Antibody MLN1202 in Patients With Bone Metastases|
- Urinary NTX (uNTX) response as measured from baseline to 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Mean change in uNTX from baseline to 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- L1-regularized regression [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Serum Trap 5b, serum bone alkaline phosphatase, serum CTX, serum CCL2, and PSA measurements at baseline and 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Allele frequencies of defined SNPs occurring in the CCL2 and CCR2 genes [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||March 2010|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
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|
- 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.