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


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Urinary NTX (uNTX) response as measured from baseline to 6 weeks

Outcome Time Frame:

6 weeks

Safety Issue:

No

Principal Investigator

Kenneth J. Pienta, MD, FACP

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000659510

NCT ID:

NCT01015560

Start Date:

March 2010

Completion Date:

December 2012

Related Keywords:

  • Metastatic Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • bone metastases
  • unspecified adult solid tumor, protocol specific
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Bone Neoplasms
  • Bone Marrow Diseases

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
CCOP - WichitaWichita, Kansas  67214-3882
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - DaytonKettering, Ohio  45429
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Cancer Therapy and Research CenterSan Antonio, Texas  78229
University Hospital - San AntonioSan Antonio, Texas  78229
Reid Hospital & Health Care ServicesRichmond, Indiana  47374
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Lawrence Memorial HospitalLawrence, Kansas  66044
Cancer Center of Kansas, PA - LiberalLiberal, Kansas  67905
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Wayne HospitalGreenville, Ohio  45331
Clinton Memorial HospitalWilmington, Ohio  45177
MedCentral - Mansfield HospitalMansfield, Ohio  44903
Glendale Memorial Hospital Comprehensive Cancer CenterGlendale, California  91204
Lovelace Medical Center - DowntownAlbuquerque, New Mexico  87102
University of New Mexico Cancer Center - SouthLas Cruces, New Mexico  88011