S0916, MLN1202 in Treating Patients With Bone Metastases - Full Text View

Purpose

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.

Condition	Intervention	Phase
Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific	Drug: anti-CCR2 monoclonal antibody MLN1202 Genetic: polymorphism analysis Other: laboratory biomarker analysis	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	S0916, A Phase II, Window Trial of the Anti-CCR2 Antibody MLN1202 in Patients With Bone Metastases

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:

Urinary NTX (uNTX) response as measured from baseline to 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean change in uNTX from baseline to 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
L1-regularized regression [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Serum Trap 5b, serum bone alkaline phosphatase, serum CTX, serum CCL2, and PSA measurements at baseline and 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Allele frequencies of defined SNPs occurring in the CCL2 and CCR2 genes [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment:	44
Study Start Date:	March 2010
Study Completion Date:	December 2012
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01015560

Show 47 Study Locations

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Kenneth J. Pienta, MD, FACP

University of Michigan Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Southwest Oncology Group
ClinicalTrials.gov Identifier:	NCT01015560 History of Changes
Other Study ID Numbers:	CDR0000659510, S0916, U10CA032102
Study First Received:	November 17, 2009
Last Updated:	December 7, 2012
Health Authority:	United States: Federal Government United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:

bone metastases
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Pathologic Processes
Neoplasms by Site

Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013