S0916, MLN1202 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.

DISEASE CHARACTERISTICS:

- Radiographically documented metastases to the bone by bone scan, x-ray, CT scan, MRI,
or PET scan within the past 42 days

- Documentation of progression of metastatic disease by serial scans is not
required for study entry

- No untreated or progressive brain metastases

- History of brain metastases allowed provided they have been treated and remain
controlled

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-2

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Must consent to urine and blood specimen submissions

- No concurrent uncontrolled illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situation that would limit compliance with
the study requirements

- No known hypersensitivity to anti-CCR2 monoclonal antibody MLN1202 or other
recombinant human antibodies

PRIOR CONCURRENT THERAPY:

- At least 14 days since prior radiotherapy and recovered (≤ grade 1 from all related
toxicities)

- At least 84 days since prior radionuclide therapy (e.g., strontium, samarium) and
recovered (≤ grade 1 from all related toxicities)

- More than 14 days since prior investigational agents, chemotherapeutic agents, or
other anticancer agents

- Concurrent bisphosphonate therapy for bone metastases allowed provided treatment was
initiated ≥ 28 days before study entry

- No initiation of bisphosphonates during study treatment

- Concurrent hormonal therapy (e.g., anti-estrogens or anti-androgens) or stable doses
of steroids for cancer allowed provided treatment was initiated > 14 days before study
entry

- No concurrent G-CSF or other growth factor support