Safety Study of Radiation and CP-675,206 Infusion for Breast Cancer Patients

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. Identifier: NCT01334099
Recruitment Status : Terminated (Contract with drug supplier expired and was not renewed.)
First Posted : April 12, 2011
Last Update Posted : June 22, 2015
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
The purpose of this study is to determine the maximum dose of CP-675,206 when given in combination with radiation. Patients will be given local radiation to one tumor site and an intravenous infusion of CP-675,206.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Biological: CP-675,206 Radiation: External local radiation therapy Phase 1

Detailed Description:

Breast cancer is the most common cancer in Canadian women. In 2007 an estimated 22,300 women will be diagnosed and 5300 will die of the disease. Despite advances in therapy, metastatic disease remains an incurable illness, with a median survival of only 2 years. Standard systemic treatment options for metastatic disease include chemotherapy or hormonal therapy. Radiation is frequently used in the metastatic setting for palliation of symptoms, with the most frequent site of radiation being bone. Response rates to first line chemotherapy are in the range of 30%, however these responses are not durable. Currently there are no curative options for metastatic disease, underscoring the need for novel therapeutic approaches.

CTLA4 is a receptor expressed on the surface of activated T cells and regulatory T cells. CTLA-blockade has been tested in clinical trials using humanized monoclonal antibodies, and some biological responses have been reported. The anti-tumor immune response may be further augmented by the combination of CTLA4-blockade with radiation, with the potential to mediate regression of metastases outside of the field of radiation. The primary goal of this study therefore is to establish the safety of CTLA4-blockade using the antibody CP-675, 206 in combination with radiation. This trial is being conducted as a prelude to a planned phase II trial of CP-675,206 in combination with radiation in metastatic breast cancer.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Local Radiation and CP-675,206 Administration in Patients With Inoperable Locally Recurrent or Metastatic Breast Cancer
Study Start Date : July 2010
Actual Primary Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Radiation combined with CP-675,206 Biological: CP-675,206
Intravenous infusion for one cycle (further cycles permitted as per medical assessment). Patient assigned dose of 3mg/kg, 6mg/kg, 10mg/kg, or 15mg/kg.
Radiation: External local radiation therapy
One cycle of 2000cGy administered locally to one site over 5 days.

Primary Outcome Measures :
  1. Assessing safety through toxicities observed using CTCAE version 3.0 [ Time Frame: At each study visit for the duration of the 12-week cycle ]

Secondary Outcome Measures :
  1. Evaluating lesions using Response Evaluation Criteria in Solid Tumors (RECIST 1.0) [ Time Frame: Every 8 weeks after treatment ]
  2. Immunological responses to the treatment measured through analysis of blood draws [ Time Frame: At the end of the 12-week cycle ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Inoperable locally recurrent or metastatic breast cancer
  • Performance status 0-1
  • Adequate organ function as determined by lab tests
  • Greater than 3 weeks since any chemotherapy treatment
  • Greater than 2 weeks since last dose of hormonal therapy

Exclusion Criteria:

  • Previous treatment with any anti-CTLA4 agent
  • Patients with active diarrhea
  • Patients who will receive radiation to pelvic lesions
  • History of chronic inflammatory or autoimmune disorder
  • History of insulin-dependent diabetes
  • History in the last 5 years of any chronic gastrointestinal conditions
  • History within the last year of congestive heart failure, stroke, myocardial infarction or thromboembolic event
  • Patients with known brain metastasis
  • Concurrent treatment with immunosuppressive medication for longer than 10 days within 4 weeks of enrollment or while on trial
  • Patients of reproductive potential not using effective contraception, breast-feeding, or patients who test positive for pregnancy at enrollment

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 identifier (NCT number): NCT01334099

Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Principal Investigator: Srikala Sridhar, MD FRCPC University Health Network - Princess Margaret Hospital

Responsible Party: University Health Network, Toronto Identifier: NCT01334099     History of Changes
Other Study ID Numbers: GA3671RD IIR#1
First Posted: April 12, 2011    Key Record Dates
Last Update Posted: June 22, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs