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

This study has been terminated.
(Contract with drug supplier expired and was not renewed.)
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01334099
First received: January 18, 2011
Last updated: March 16, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Metastatic Breast Cancer
Biological: CP-675,206
Radiation: External local radiation therapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

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

Secondary Outcome Measures:
  • Evaluating lesions using Response Evaluation Criteria in Solid Tumors (RECIST 1.0) [ Time Frame: Every 8 weeks after treatment ] [ Designated as safety issue: Yes ]
  • Immunological responses to the treatment measured through analysis of blood draws [ Time Frame: At the end of the 12-week cycle ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: July 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

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

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
  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: NCT01334099

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

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01334099     History of Changes
Other Study ID Numbers: GA3671RD IIR#1
Study First Received: January 18, 2011
Last Updated: March 16, 2012
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tremelimumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014