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Fresolimumab and Radiotherapy in Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01401062
Recruitment Status : Completed
First Posted : July 25, 2011
Results First Posted : April 6, 2017
Last Update Posted : March 5, 2019
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Fresolimumab Radiation: Radiation Therapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fresolimumab and Radiotherapy in Metastatic Breast Cancer
Study Start Date : July 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Arm 1 (Fresolimumab 1 mg/kg)
Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).
Drug: Fresolimumab
Other Name: GC1008

Radiation: Radiation Therapy
Experimental: Arm 2 (Fresolimumab 10 mg/kg)
Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).
Drug: Fresolimumab
Other Name: GC1008

Radiation: Radiation Therapy



Primary Outcome Measures :
  1. Abscopal Response Rate [ Time Frame: up to 20 weeks ]
    Defined as the percentage of patients who have responses (complete or partial) outside the irradiated lesions. The abscopal response is assessed at 15 weeks, and confirmed minimum 4 weeks later. The abscopal response is evaluated based on immune-related response criteria (irRC) (Wolchok et al, 2009).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01401062


Locations
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United States, California
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095-1714
United States, New York
New York University Langone Medical Center Cancer Center
New York, New York, United States, 10016
Sponsors and Collaborators
Weill Medical College of Cornell University
University of California, Los Angeles
Investigators
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Principal Investigator: Silvia Formenti, M.D. NYU Langone Health
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01401062    
Other Study ID Numbers: S11-00533
BC100481 ( Other Grant/Funding Number: DOD )
First Posted: July 25, 2011    Key Record Dates
Results First Posted: April 6, 2017
Last Update Posted: March 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Weill Medical College of Cornell University:
metastatic breast cancer
TGF-beta
fresolimumab
monoclonal antibody
radiation therapy
abscopal response
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases