Fresolimumab and Radiotherapy in Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01401062
First received: July 20, 2011
Last updated: December 30, 2015
Last verified: December 2015

July 20, 2011
December 30, 2015
July 2011
June 2014   (final data collection date for primary outcome measure)
Abscopal response rate [ Time Frame: up to 20 weeks ] [ Designated as safety issue: No ]
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).
Percentage of Participants with Adverse Events [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Physical exam every 2 weeks while on trial and at 3 monthly follow up visits will monitor patients for Adverse events using the NCI CTCAE vers. 4.0.
Complete list of historical versions of study NCT01401062 on ClinicalTrials.gov Archive Site
Not Provided
Local response rate [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Responses will be assessed at week 5 and week 15 of the trial by PET/CT. Tumor measurements must be recorded in millimeters (or decimal fractions of centimeters). Criteria as described by the European Organisation for Research and Treatment of Cancer (EORTC) PET study group will be used to assess response based on standard uptake value (SUV).
Not Provided
Not Provided
 
Fresolimumab and Radiotherapy in Metastatic Breast Cancer
Fresolimumab and Radiotherapy in Metastatic Breast Cancer
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
  • Drug: Fresolimumab
    Other Name: GC1008
  • Radiation: Radiation Therapy
  • 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).
    Interventions:
    • Drug: Fresolimumab
    • 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).
    Interventions:
    • Drug: Fresolimumab
    • Radiation: Radiation Therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
24
March 2016
June 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01401062
S11-00533, BC100481
Yes
Not Provided
Not Provided
New York University School of Medicine
New York University School of Medicine
University of California, Los Angeles
Principal Investigator: Silvia Formenti, M.D. New York University School of Medicine
New York University School of Medicine
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP