Stereotactic Body Radiation and Monoclonal Antibody to OX40 in Breast Cancer Patients With Metastatic Lesions (OX40 Breast)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Providence Health & Services
Sponsor:
Collaborators:
Robert W. Franz Cancer Center
Providence Cancer Center
Providence Cancer Center, Earle A. Chiles Research Institute
Information provided by (Responsible Party):
Providence Health & Services
ClinicalTrials.gov Identifier:
NCT01862900
First received: May 22, 2013
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

This study will test the investigational antibody, anti-OX40, in combination with stereotactic body radiation in breast cancer patients that have liver or lung metastases and have received systemic therapy and have progressive disease. The investigators hypothesize that SBRT directed at metastatic breast cancer lesions will result in a systemic anti-tumor immune system response. This amplified and directed immune response could result in anti-tumor responses.


Condition Intervention Phase
Metastatic Breast Cancer
Lung Metastases
Liver Metastases
Biological: anti-OX40 antibody
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of Stereotactic Body Radiation Therapy to Metastatic Lesions in the Liver or Lung in Combination With Monoclonal Antibody to OX40 in Patients With Progressive Metastatic Breast Cancer After Systemic Therapy.

Resource links provided by NLM:


Further study details as provided by Providence Health & Services:

Primary Outcome Measures:
  • Determine the maximum tolerated dose and safety profile of radiation administered in combination with anti-OX40 in patients with metastatic breast cancer. [ Time Frame: From Day 1 to Day 36 ] [ Designated as safety issue: Yes ]
    A dose limiting toxicity (DLT) is defined as any greater than or equal to grade 3 non-hematologic toxicity (except hypothyroidism or vitiligo) that in the opinion of the investigator is considered at least possibly related to treatment. Grade 3 or 4 hematologic toxicities that take longer than 10 days to resolve will be considered DLTs. Patients will have 8 clinic visits over 36 days to identify toxicities.


Secondary Outcome Measures:
  • Estimate the response rate of combined modality treatment in both irradiated and non-irradiated tumors. [ Time Frame: Day 36 ] [ Designated as safety issue: No ]
    Patients will have CT scans for tumor measurements at Day 36. Patients achieving a radiographic response, or are stable, will be followed monthly with physical exam and laboratory studies with CT (or other imaging as deemed appropriate) scans obtained every 3 months (± 2 weeks) for up to 24 months and then ever 6 months (± 2 weeks) for up to 4 years.


Other Outcome Measures:
  • Determine the influence of anti-OX40 and radiation on circulating CD4+ and CD8+ T cells. [ Time Frame: Screening to Day 36 ] [ Designated as safety issue: No ]
    Patients will provide 9 blood samples over 36 days to measure the number of CD4+ and CD8+ T Cells.


Estimated Enrollment: 40
Study Start Date: February 2013
Estimated Study Completion Date: February 2023
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 15 Gy
Patients receive a radiation dose of 15 Gy to their liver or lung metastases. Patients receive a dose of anti-OX40 antibody following radiation and on Days 3, and 5.
Biological: anti-OX40 antibody
Patients receive 3 doses of anti-OX40; one on Days 1, 3, and 5
Experimental: 20 Gy
Patients receive a radiation dose of 20 Gy to their liver or lung metastases. Patients receive a dose of anti-OX40 antibody following radiation and on Days 3, and 5.
Biological: anti-OX40 antibody
Patients receive 3 doses of anti-OX40; one on Days 1, 3, and 5
Experimental: 25 Gy
Patients receive a radiation dose of 25 Gy to their liver or lung metastases. Patients receive a dose of anti-OX40 antibody following radiation and on Days 3, and 5.
Biological: anti-OX40 antibody
Patients receive 3 doses of anti-OX40; one on Days 1, 3, and 5

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed breast cancer with clinical evidence of stage 4 disease
  • Measurable disease and at least one lesion in either liver or lung that is amenable to stereotactic body radiation
  • One site of disease that will not receive radiation
  • Patients with hormone receptor positive breast cancer must have received prior anti-hormonal therapy for metastatic disease and have progressed and patients with hormone receptor negative breast cancer must have received at least one prior chemotherapy regimen and progressed.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
  • Women of childbearing potential must have a negative pregnancy test on the day treatment starts and must avoid becoming pregnant while on treatment. Men must avoid fathering a child while on treatment.
  • Patients must have blood test results within pre-specified range
  • No active bleeding
  • No clinical coagulopathy (INR <1.5, PT <16 seconds, PTT < 38 seconds) within 28 days
  • Anticipated lifespan greater than 12 weeks

Exclusion Criteria:

  • Active infection requiring systemic antibiotics.
  • Active autoimmune disease as defined by the autoimmune disease assessment tool.
  • Previous treatment with mouse monoclonal antibodies
  • At least 28 days since prior chemotherapy or monoclonal antibody therapy (trastuzumab or bevacizumab). Patients who have been on hormonal therapy can continue on therapy at the discretion of the investigator. Bisphosphonate therapy is acceptable during study participation.
  • Diagnosis of a solid tumor malignancy (excluding non-melanoma skin cancer) within 3 years of enrollment.
  • Need for chronic maintenance oral steroids.
  • Active brain metastatic disease. Treated brain metastases with surgery, gamma-knife radiosurgery or radiation and stable for at least 4 weeks and off steroids are eligible.
  • No metastatic site amenable to SBRT
  • Pregnant or lactating women, as treatment involves risks to the embryo or fetus.
  • Other medical or psychiatric conditions that in the opinion of the Principal Investigator would preclude safe participation in protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01862900

Contacts
Contact: Nikki Moxon, RN (503) 215-2619 nicole.moxon@providence.org
Contact: Brenda Fisher, RN (503) 215-2613 brenda.fisher@providence.org

Locations
United States, Oregon
Portland Providence Medical Center Recruiting
Portland, Oregon, United States, 97213
Principal Investigator: Marka R Crittenden, MD, PhD         
Principal Investigator: Brendan Curti, MD         
Principal Investigator: Steven Seung, MD         
Sub-Investigator: Steven Bader, MD         
Sub-Investigator: Christine Cha, MD         
Sub-Investigator: Todd Crocenz, MD         
Sub-Investigator: Rachel Sanborn, MD         
Sub-Investigator: Matthew Solhjem, MD         
Sub-Investigator: Walter J. Urba, MD, PhD         
Sub-Investigator: Alice Wang-Chesebro, MD         
Sub-Investigator: Katie Strauss, RN         
Sub-Investigator: John Smith, MD         
Principal Investigator: Alison Conlin, MD         
Sponsors and Collaborators
Providence Health & Services
Robert W. Franz Cancer Center
Providence Cancer Center
Providence Cancer Center, Earle A. Chiles Research Institute
Investigators
Principal Investigator: Marka R Crittenden, MD, PhD Providence Cancer Center, Earle A. Chiles Research Institute
Principal Investigator: Brendan Curti, MD Providence Cancer Center, Earle A. Chiles Research Institute
Principal Investigator: Steven Seung, MD Providence Cancer Center, Earle A. Chiles Research Institute
Principal Investigator: Alison Conlin, MD Providence Cancer Center, Earle A. Chiles Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Providence Health & Services
ClinicalTrials.gov Identifier: NCT01862900     History of Changes
Obsolete Identifiers: NCT01642290
Other Study ID Numbers: 12-017A
Study First Received: May 22, 2013
Last Updated: December 9, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Providence Health & Services:
Breast Cancer
Metastatic
Lung metastases
Liver metastases
Stereotactic body radiation
anti-OX40 antibody

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Lung Neoplasms
Liver Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014