Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
S0916, A Phase II, Window Trial of the Anti-CCR2 Antibody MLN1202 in 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.
OBJECTIVES:
Primary
- To assess the urinary n-telopeptide (uNTX) response to anti-CCR2 monoclonal antibody
MLN1202 in patients with bone metastases.
Secondary
- 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.
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