Fresolimumab and Radiotherapy in Metastatic Breast Cancer

February 21, 2019 updated by: Weill Medical College of Cornell University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095-1714
        • David Geffen School of Medicine at UCLA
    • New York
      • New York, New York, United States, 10016
        • New York University Langone Medical Center Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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).
Radiation: Radiation Therapy
Drug: Fresolimumab
Other Names:
  • GC1008
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).
Radiation: Radiation Therapy
Drug: Fresolimumab
Other Names:
  • GC1008

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
up to 20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

University of California, Los Angeles

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

July 20, 2011

First Submitted That Met QC Criteria

July 21, 2011

First Posted (Estimate)

July 25, 2011

Study Record Updates

Last Update Posted (Actual)

March 5, 2019

Last Update Submitted That Met QC Criteria

February 21, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S11-00533
  • BC100481 (Other Grant/Funding Number: DOD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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