Phase 2
N=44
S0916, MLN1202 in Treating Patients With Bone Metastases
Metastatic Cancer · Unspecified Adult Solid Tumor, Protocol Specific
Bottom Line
View on ClinicalTrials.gov: NCT01015560 ↗Enrolled (actual)
44
Serious AEs
7.1%
Results posted
May 2014
Primary outcome: Primary: uNTX Response Rate at 43 Days — 14 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- anti-CCR2 monoclonal antibody MLN1202 (Drug); polymorphism analysis (Genetic); laboratory biomarker analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SWOG Cancer Research Network
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY uNTX Response Rate at 43 Days |
14 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01015560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.