S0916, MLN1202 in Treating Patients With Bone Metastases
Condition: Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neoplasm Metastasis
Intervention: anti-CCR2 monoclonal antibody MLN1202; polymorphism analysis; laboratory biomarker analysis
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: bone metastases; unspecified adult solid tumor, protocol specific

Summary:

      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.
    

Eligibility 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