SWOG clinical trial number
S0916

A Phase II Trial of the Anti-CCR2 Antibody MLN1202 in Patients with Bone Metastases

Closed
Phase
Accrual
98%
Abbreviated Title
Anti-CCR2 Ab for Bone Metastases
Activated
03/01/2010
Closed
03/15/2011
Participants
Limited: Institutions Listed on SWOG Activation Memorandum

Research committees

Early Therapeutics & Rare Cancers
Breast Cancer
Gastrointestinal Cancer
Genitourinary Cancer
Gynecologic Cancer
Lung Cancer
Myeloma

Treatment

MLN1202

Eligibility Criteria Expand/Collapse

Pts must be >/= 18 yrs. Pts must consent to urine/blood specimen submissions outlined. Pts must be offered participation in banking. Pts must have metastatic disease to bone assessed by bone scan, X-ray, CT, MRI or PET. Prior radiation is permitted if completed at least 14 days prior to reg and pt recovered to </= Grade 1 from all toxicities. Prior radionuclide therapy is permitted if completed at least 84 days prior to reg and pt recovered to </= Grade 1 from all toxicities. Pts must have Zubrod PS 0-2. Bisphosphonate therapy for bone mets allowed if tx was initiated at least 28 days prior to reg. Initiation of bisphosphonates during study tx is not allowed. Pts must not have uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congesting heart failure, unstable angina, pectoris, cardiac arrhythmia, psychiatric illness/social situations that would limit compliance with study requirements. Pts must not have been treated with an investigational, chemotherapeutic or other anti-cancer agent within 14 days prior to reg. Pts may remain on hormonal therapy or stable doses of steroids for cancer as long as they have been on the drugs for > 14 days prior to initiation of protocol tx. Pts must not have known hypersensitivity to MLN1202 or other recombinant human antibodies. Pts with history of brain mets that have been treated and remain controlled are eligible. Pts with untreated or progressive brain mets are not eligible. Pts must not be pregnant or nursing. Women of reproductive potential must have a negative pregnancy test within 14 days prior to reg. Women/men of reproductive potential must have agreed to use an effective contraceptive method. All pts must be informed of the investigational nature of the study and must sign and give written informed consent in accordance with institutional and federal guidelines.