S0916, A Phase II, Window Trial of the Anti-CCR2 Antibody MLN1202 in Patients With Bone Metastases

Inclusion Criteria

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