Skip to content

S0916, MLN1202 in Treating Patients With Bone Metastases

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01015560
Enrollment
44
Registered
2009-11-18
Start date
2010-03-31
Completion date
2012-12-31
Last updated
2018-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Keywords

bone metastases, unspecified adult solid tumor, protocol specific

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.

Interventions

DRUGanti-CCR2 monoclonal antibody MLN1202
GENETICpolymorphism analysis
OTHERlaboratory biomarker analysis

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
SWOG Cancer Research Network
Lead SponsorNETWORK

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
uNTX Response Rate at 43 Days43 daysUrinary n-telopeptide (uNTX) response is defined as a 25% reduction from baseline levels. Patients with missing response data were included as non-responders.

Countries

United States

Participant flow

Participants by arm

ArmCount
MLN 1202
MLN1202 8mg/kg IV Days 1, 15, 29 given as one 6-week cycle
43
Total43

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAdverse Event1
Overall StudyNot protocol specified1
Overall StudyWithdrawal by Subject1

Baseline characteristics

CharacteristicMLN 1202
Age, Continuous65 years
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
30 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
12 Participants
Race/Ethnicity, Customized
Black
4 participants
Race/Ethnicity, Customized
White
39 participants
Sex: Female, Male
Female
24 Participants
Sex: Female, Male
Male
19 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
30 / 42
serious
Total, serious adverse events
3 / 42

Outcome results

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.

Time frame: 43 days

Population: Eligible and analyzable patients

ArmMeasureValue (NUMBER)
MLN 1202uNTX Response Rate at 43 Days14 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026