S0916, MLN1202 in Treating Patients With Bone Metastases

SWOG Cancer Research Network

Status and phase

Completed

Phase 2

Conditions

Metastatic Cancer

Unspecified Adult Solid Tumor, Protocol Specific

Treatments

Drug: anti-CCR2 monoclonal antibody MLN1202

Other: laboratory biomarker analysis

Genetic: polymorphism analysis

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT01015560

S0916 (Other Identifier)

U10CA032102 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

44 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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