Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT01015560
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT01015560
Study Brief:
Protocol Section:
NCT01015560