S0916, MLN1202 in Treating Patients With Bone Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01015560
Recruitment Status : Completed
First Posted : November 18, 2009
Results First Posted : May 28, 2014
Last Update Posted : March 25, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Brief 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.

Condition or disease Intervention/treatment Phase
Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific Drug: anti-CCR2 monoclonal antibody MLN1202 Genetic: polymorphism analysis Other: laboratory biomarker analysis Phase 2

Detailed Description:



  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: S0916, A Phase II, Window Trial of the Anti-CCR2 Antibody MLN1202 in Patients With Bone Metastases
Study Start Date : March 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: treatment
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

Primary Outcome Measures :
  1. uNTX Response Rate at 43 Days [ Time Frame: 43 days ]
    Urinary n-telopeptide (uNTX) response is defined as a 25% reduction from baseline levels. Patients with missing response data were included as non-responders.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01015560

  Show 47 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Kenneth J. Pienta, MD, FACP University of Michigan Cancer Center

Responsible Party: Southwest Oncology Group Identifier: NCT01015560     History of Changes
Other Study ID Numbers: S0916
S0916 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: November 18, 2009    Key Record Dates
Results First Posted: May 28, 2014
Last Update Posted: March 25, 2015
Last Verified: March 2015

Keywords provided by Southwest Oncology Group:
bone metastases
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs