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| ID | Type | Description | Link |
|---|---|---|---|
| S0916 | Other Identifier | SWOG | |
| U10CA032102 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Experimental | MLN1202 8mg/kg IV Days 1, 15, 29 given as 1 6 week cycle |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-CCR2 monoclonal antibody MLN1202 | Drug |
| ||
| polymorphism analysis |
| 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 |
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DISEASE CHARACTERISTICS:
Radiographically documented metastases to the bone by bone scan, x-ray, CT scan, MRI, or PET scan within the past 42 days
No untreated or progressive brain metastases
PATIENT CHARACTERISTICS:
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
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
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth J. Pienta, MD, FACP | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glendale Memorial Hospital Comprehensive Cancer Center | Glendale | California | 91204 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | MLN 1202 | MLN1202 8mg/kg IV Days 1, 15, 29 given as one 6-week cycle |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Genetic |
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| laboratory biomarker analysis | Other |
|
| USC/Norris Comprehensive Cancer Center and Hospital |
| Los Angeles |
| California |
| 90089-9181 |
| United States |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana | 46107 | United States |
| Reid Hospital & Health Care Services | Richmond | Indiana | 47374 | United States |
| Cancer Center of Kansas, PA - Chanute | Chanute | Kansas | 66720 | United States |
| Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas | 67801 | United States |
| Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas | 67042 | United States |
| Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas | 66701 | United States |
| Cancer Center of Kansas-Independence | Independence | Kansas | 67301 | United States |
| Cancer Center of Kansas, PA - Kingman | Kingman | Kansas | 67068 | United States |
| Lawrence Memorial Hospital | Lawrence | Kansas | 66044 | United States |
| Cancer Center of Kansas, PA - Liberal | Liberal | Kansas | 67905 | United States |
| Cancer Center of Kansas, PA - Newton | Newton | Kansas | 67114 | United States |
| Cancer Center of Kansas, PA - Parsons | Parsons | Kansas | 67357 | United States |
| Cancer Center of Kansas, PA - Pratt | Pratt | Kansas | 67124 | United States |
| Cancer Center of Kansas, PA - Salina | Salina | Kansas | 67401 | United States |
| Cancer Center of Kansas, PA - Wellington | Wellington | Kansas | 67152 | United States |
| Associates in Womens Health, PA - North Review | Wichita | Kansas | 67208 | United States |
| Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas | 67208 | United States |
| Cancer Center of Kansas, PA - Wichita | Wichita | Kansas | 67214 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214 | United States |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas | 67214 | United States |
| Cancer Center of Kansas, PA - Winfield | Winfield | Kansas | 67156 | United States |
| Lucille P. Markey Cancer Center at University of Kentucky | Lexington | Kentucky | 40536-0093 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-0942 | United States |
| Lovelace Medical Center - Downtown | Albuquerque | New Mexico | 87102 | United States |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87131-5636 | United States |
| University of New Mexico Cancer Center - South | Las Cruces | New Mexico | 88011 | United States |
| Grandview Hospital | Dayton | Ohio | 45405 | United States |
| Good Samaritan Hospital | Dayton | Ohio | 45406 | United States |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio | 45409 | United States |
| Samaritan North Cancer Care Center | Dayton | Ohio | 45415 | United States |
| CCOP - Dayton | Dayton | Ohio | 45420 | United States |
| Blanchard Valley Medical Associates | Findlay | Ohio | 45840 | United States |
| Middletown Regional Hospital | Franklin | Ohio | 45005-1066 | United States |
| Wayne Hospital | Greenville | Ohio | 45331 | United States |
| Charles F. Kettering Memorial Hospital | Kettering | Ohio | 45429 | United States |
| MedCentral - Mansfield Hospital | Mansfield | Ohio | 44903 | United States |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio | 45373-1300 | United States |
| Clinton Memorial Hospital | Wilmington | Ohio | 45177 | United States |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio | 45385 | United States |
| Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio | Texas | 78209 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229-3900 | United States |
| Cancer Therapy and Research Center | San Antonio | Texas | 78229 | United States |
| University Hospital - San Antonio | San Antonio | Texas | 78229 | United States |
| Eligible and Analyzable |
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| COMPLETED |
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| NOT COMPLETED |
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Eligible and analyzable patients included.
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| ID | Title | Description |
|---|---|---|
| BG000 | MLN 1202 | MLN1202 8mg/kg IV Days 1, 15, 29 given as one 6-week cycle |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Eligible and analyzable patients | Posted | Number | 95% Confidence Interval | percentage of participants | 43 days |
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Minimum of 30 days after the last dose of protocol therapy, or every 4 to 6 weeks until all protocol therapy-related toxicities resolve, return to baseline, or are deemed irreversible, whichever is longer.
Only eligible and analyzable patients that were assessed for adverse events are included. One patient was not assessed for adverse events and is not included in this analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MLN 1202 | MLN1202 8mg/kg IV Days 1, 15, 29 given as one 6-week cycle | 3 | 42 | 30 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Edema limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| CD4 lymphocytes decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Statistician | SWOG Statistical Center | 206-667-4623 |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C558499 | plozalizumab |
| D054458 | Amplified Fragment Length Polymorphism Analysis |
| ID | Term |
|---|---|
| D016172 | DNA Fingerprinting |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D016133 | Polymerase Chain Reaction |
| D021141 | Nucleic Acid Amplification Techniques |
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| Unknown or Not Reported |
|