Expired Study
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New York, New York 10016


Purpose:

The purpose of this study is to test safety of combining fresolimumab and local radiotherapy and to see if the combination can achieve tumor regression.


Criteria:

Inclusion Criteria: - Biopsy-proven breast cancer, metastatic (persistent or recurrent). - Failed ≥1 line of therapy (endocrine or chemotherapy) for metastatic disease. - Min. 3 distinct metastatic sites, at least one measurable lesion which is at least 1 cm or larger in largest diameter. - Must be ≥4 weeks since all of the following treatments (recovered from toxicity of prior treatment to ≤Grade 1, excluding alopecia): - major surgery; - radiotherapy; - chemotherapy (≥6 weeks since therapy if a nitrosourea, mitomycin, or monoclonal antibodies such as bevacizumab); - immunotherapy; - biotherapy/targeted therapies. - >18 years of age. - Life expectancy >6 months. - Eastern Cooperative Oncology Group (ECOG) status 0 or 1. - Adequate organ function including: - Hemoglobin ≥10.0g/dL, absolute neutrophil count (ANC) ≥1,500/mm3, and platelets ≥100,000/mm3. - Hepatic: Serum total bilirubin ≤1.5x upper limit of normal (ULN) (Patients with Gilbert's Disease may be included if total bilirubin is ≤3.0mg/dL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤2.5xULN. If patient has known liver metastases, ALT and/or AST ≤5xULN are allowed. - Renal: creatinine clearance ≥60mL/min. - Prothrombin (PT) and partial thromboplastin times (PTT) <ULN. - Negative for hepatitis viruses B and C unless consistent with prior vaccination or prior infection with full recovery. - Patients of childbearing potential must agree to use effective contraception while on study, and for ≥3 months after last treatment. - Understand and sign written informed consent document. No consent by durable power of attorney. Exclusion Criteria: - Second malignancy - unless following curative intent therapy, has been disease free for ≥2 years with probability of recurrence <5%. Curatively treated early-stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia (CIN) are allowed. - Concurrent cancer therapy. - Uncontrolled central nervous system (CNS) metastases, meningeal carcinomatosis, malignant seizures, or disease that causes or threatens neurologic compromise (e.g. unstable vertebral metastases). - History of ascites or pleural effusions, unless successfully treated. - Organ transplant, including allogeneic bone marrow transplant. - Immunosuppressive therapy including: - Systemic corticosteroid therapy, including replacement therapy for hypoadrenalism. Inhaled or topical corticosteroids are allowed (if therapy is <5 days and is limited to systemic steroids as antiemetics); - Cyclosporine A, tacrolimus, or sirolimus. - Investigational agents within 4 weeks prior to study enrollment (≥6 weeks if treatment was long-acting agent such as monoclonal antibody). - Significant or uncontrolled medical illness, e.g. congestive heart failure (CHF), myocardial infarction, symptomatic coronary artery disease, significant ventricular arrhythmias within the last 6 months, or significant pulmonary dysfunction. Patients with remote history of asthma or active mild asthma may participate. - Active infection, including unexplained fever (>38.5°C). - Systemic autoimmune disease (e.g. systemic lupus erythematosus, active rheumatoid arthritis). - Known allergy to any component of GC1008. - Active thrombophlebitis, thromboembolism, hypercoagulability states, bleeding, or anti-coagulation therapy (including anti platelet agents i.e. aspirin, clopidogrel, ticlopidine, dipyridamole, other agents inducing long-acting platelet dysfunction). Patients with history of deep venous thrombosis are allowed if treated, completely resolved, and no treatment for >4months. - Calcium >11.0mg/dL (2.75mmol/L) unresponsive or uncontrolled in response to standard therapy (e.g. bisphosphonates). - Patients who, in the opinion of the Investigator, have significant medical or psychosocial problems, including, but not limited to: - Other serious non-malignancy-associated conditions that may be expected to limit life expectancy or significantly increase the risk of SAEs; - Conditions, psychiatric, substance abuse, or other, that, in the opinion of the Investigator, would preclude informed consent, consistent follow-up, or compliance with any aspect of the study; - Pregnant or nursing women.


NCT ID:

NCT01401062


Primary Contact:

Principal Investigator
Silvia Formenti, M.D.
NYU Langone Health


Backup Contact:

N/A


Location Contact:

New York, New York 10016
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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