S0916, MLN1202 in Treating Patients With Bone Metastases

Phase 2

Completed

Conditions: Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific

Interventions: Drug: anti-CCR2 monoclonal antibody MLN1202
Genetic: polymorphism analysis
Other: laboratory biomarker analysis

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
treatment	anti-CCR2 monoclonal antibody MLN1202	MLN1202 8mg/kg IV Days 1, 15, 29 given as 1 6 week cycle
treatment	polymorphism analysis	MLN1202 8mg/kg IV Days 1, 15, 29 given as 1 6 week cycle
treatment	laboratory biomarker analysis	MLN1202 8mg/kg IV Days 1, 15, 29 given as 1 6 week cycle

Primary Outcome Measures

Name	Time	Method
uNTX Response Rate at 43 Days	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.

Secondary Outcome Measures

Name	Time	Method

Locations (47): Glendale Memorial Hospital Comprehensive Cancer Center
🇺🇸
Glendale, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸
Los Angeles, California, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸
Maywood, Illinois, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
🇺🇸
Beech Grove, Indiana, United States
Reid Hospital & Health Care Services
🇺🇸
Richmond, Indiana, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸
Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸
Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸
El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott
🇺🇸
Fort Scott, Kansas, United States
Cancer Center of Kansas-Independence
🇺🇸
Independence, Kansas, United States
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Glendale Memorial Hospital Comprehensive Cancer Center
🇺🇸Glendale, California, United States