Metastatic CancerPhase 2NCT01015560

S0916, MLN1202 in Treating Patients With Bone Metastases

A Phase 2 study testing anti-CCR2 monoclonal antibody MLN1202, polymorphism analysis and laboratory biomarker analysis in people with Metastatic Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by SWOG Cancer Research Network at 47 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 120 years
Conditions the study is for: Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
What is being tested?: anti-CCR2 monoclonal antibody MLN1202, polymorphism analysis and laboratory biomarker analysis
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 47 sitesUnited States
Study dates: Mar 2010to Dec 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 120 years
All sexes
No healthy volunteers
Adult, Older adult

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

Trial locations and contacts

47 sites in 1 country.

City, postcode or hospital

47 sites in 1 country

United States47 sites

Lovelace Medical Center - Downtown
Albuquerque, New Mexico, 87102
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87131-5636
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0942
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, 46107
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, 66720
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425
Grandview Hospital
Dayton, Ohio, 45405
Good Samaritan Hospital
Dayton, Ohio, 45406
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, 45409
Samaritan North Cancer Care Center
Dayton, Ohio, 45415
CCOP - Dayton
Dayton, Ohio, 45420
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, 67042
Blanchard Valley Medical Associates
Findlay, Ohio, 45840
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701
Middletown Regional Hospital
Franklin, Ohio, 45005-1066
Glendale Memorial Hospital Comprehensive Cancer Center
Glendale, California, 91204
Wayne Hospital
Greenville, Ohio, 45331
Cancer Center of Kansas-Independence
Independence, Kansas, 67301
Charles F. Kettering Memorial Hospital
Kettering, Ohio, 45429
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, 67068
University of New Mexico Cancer Center - South
Las Cruces, New Mexico, 88011
Lawrence Memorial Hospital
Lawrence, Kansas, 66044
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, 40536-0093
Cancer Center of Kansas, PA - Liberal
Liberal, Kansas, 67905
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90089-9181
MedCentral - Mansfield Hospital
Mansfield, Ohio, 44903
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, 60153
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
Reid Hospital & Health Care Services
Richmond, Indiana, 47374
Cancer Center of Kansas, PA - Salina
Salina, Kansas, 67401
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78209
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
Cancer Therapy and Research Center
San Antonio, Texas, 78229
University Hospital - San Antonio
San Antonio, Texas, 78229
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, 45373-1300
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, 67152
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 - Wichita
Wichita, Kansas, 67214
CCOP - Wichita
Wichita, Kansas, 67214
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, 67214
Clinton Memorial Hospital
Wilmington, Ohio, 45177
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, 67156
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, 45385

Other trials in United States

About this study

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

PURPOSE: This phase II trial is studying how well MLN1202 works in treating patients with bone metastases.

Read the 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.

Conditions: Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Being tested: anti-CCR2 monoclonal antibody MLN1202, polymorphism analysis, laboratory biomarker analysis
Keywords: bone metastases, unspecified adult solid tumor, protocol specific
Medical subject headings: Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

anti-CCR2 monoclonal antibody MLN1202Drug
polymorphism analysisGenetic
laboratory biomarker analysisOther

Study groups in NCT01015560
Study group	Role	What they receive
treatment	Experimental	MLN1202 8mg/kg IV Days 1, 15, 29 given as 1 6 week cycle Receives: Drug: anti-CCR2 monoclonal antibody MLN1202; Genetic: polymorphism analysis; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 43 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010Dec 2012

First posted18 Nov 2009 (estimated)
Study startMar 2010
Primary completionDec 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Metastatic CancerStudies of the same condition, open and under way.
More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01015560
Sponsor's protocol ID: S0916
Other IDs: S0916, U10CA032102
Status last verified: Jul 2018
First submitted: 17 Nov 2009
Last updated: 9 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: S0916, A Phase II, Window Trial of the Anti-CCR2 Antibody MLN1202 in Patients With Bone Metastases
ClinicalTrials.gov ID: NCT01015560
Acronym / sponsor ID: S0916
Conditions: Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Keywords: bone metastases, unspecified adult solid tumor, protocol specific
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: SWOG Cancer Research NetworkResearch network
Collaborators: National Cancer Institute (NCI)
Study start: Mar 2010
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 18 Nov 2009 (estimated)
Results: Posted 28 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
treatment	Experimental	Drug: anti-CCR2 monoclonal antibody MLN1202, Genetic: polymorphism analysis, Other: laboratory biomarker analysisMLN1202 8mg/kg IV Days 1, 15, 29 given as 1 6 week cycle

Who may qualify

Ages: 18 to 120 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
anti-CCR2 monoclonal antibody MLN1202	Drug	treatment
polymorphism analysis	Genetic	treatment
laboratory biomarker analysis	Other	treatment

Primary outcome

uNTX Response Rate at 43 Days
Time frame: 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.

Results and safety

Results posted to the registry on 28 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MLN 1202	44	41

Primary outcome: uNTX Response Rate at 43 Days

Time frame: 43 days. Number (95% Confidence Interval). Unit: percentage of participants

Measure	MLN 1202 n = 43
Value	14 (5 to 27)

Population analysed: Eligible and analyzable patients

Adverse events

Time frame: 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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MLN 1202	3 of 42 (7.1%)	30 of 42 (71.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Metastatic Cancer

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kenneth J. Pienta, MD, FACP principal investigator

University of Michigan Rogel Cancer Center

47 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

uNTX Response Rate at 43 Days (time frame: 43 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01015560.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.