S0916, A Phase II, Window Trial of the Anti-CCR2 Antibody MLN1202 in Patients With Bone Metastases
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Urinary NTX (uNTX) response as measured from baseline to 6 weeks
6 weeks
No
Kenneth J. Pienta, MD, FACP
Principal Investigator
University of Michigan Cancer Center
United States: Federal Government
CDR0000659510
NCT01015560
March 2010
December 2012
Name | Location |
---|---|
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
CCOP - Dayton | Kettering, Ohio 45429 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio, Texas 78284 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
Lucille P. Markey Cancer Center at University of Kentucky | Lexington, Kentucky 40536-0093 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana 46107 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
Grandview Hospital | Dayton, Ohio 45405 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Good Samaritan Hospital | Dayton, Ohio 45406 |
Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
Cancer Therapy and Research Center | San Antonio, Texas 78229 |
University Hospital - San Antonio | San Antonio, Texas 78229 |
Reid Hospital & Health Care Services | Richmond, Indiana 47374 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Cancer Center of Kansas, PA - Liberal | Liberal, Kansas 67905 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Wayne Hospital | Greenville, Ohio 45331 |
Clinton Memorial Hospital | Wilmington, Ohio 45177 |
MedCentral - Mansfield Hospital | Mansfield, Ohio 44903 |
Glendale Memorial Hospital Comprehensive Cancer Center | Glendale, California 91204 |
Lovelace Medical Center - Downtown | Albuquerque, New Mexico 87102 |
University of New Mexico Cancer Center - South | Las Cruces, New Mexico 88011 |