S0916, MLN1202 in Treating Patients With Bone Metastases

Study Overview
=================
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
-----------------
* Drug: anti-CCR2 monoclonal antibody MLN1202
* Genetic: polymorphism analysis
* Other: laboratory biomarker analysis


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br>MLN1202 8mg/kg IV Days 1, 15, 29 given as 1 6 week cycle | Drug: anti-CCR2 monoclonal antibody MLN1202<br> <br> Genetic: polymorphism analysis<br> <br> Other: laboratory biomarker analysis<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| uNTX Response Rate at 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. | 43 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bone metastases, unspecified adult solid tumor, protocol specific