S0916, MLN1202 in Treating Patients With Bone Metastases

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antibodies; Antibodies, Monoclonal; Immunoglobulins

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