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

NCT01334099 | Terminated Phase 1

• 1 other identifier: GA3671RD IIR#1
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Assessing safety through toxicities observed using CTCAE version 3.0

  At each study visit for the duration of the 12-week cycle

Secondary Outcomes (2)

• Evaluating lesions using Response Evaluation Criteria in Solid Tumors (RECIST 1.0)

  Every 8 weeks after treatment

• Immunological responses to the treatment measured through analysis of blood draws

  At the end of the 12-week cycle

Study Arms (1)

Radiation combined with CP-675,206

EXPERIMENTAL

Biological: CP-675,206; Radiation: External local radiation therapy

Interventions

CP-675,206 BIOLOGICAL

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 combined with CP-675,206

External local radiation therapy RADIATION

One cycle of 2000cGy administered locally to one site over 5 days.

Radiation combined with CP-675,206

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

tremelimumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Srikala Sridhar, MD FRCPC

  University Health Network - Princess Margaret Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2011
• First Posted: April 12, 2011
• Study Start: July 1, 2010
• Primary Completion: March 1, 2013
• Last Updated: June 22, 2015

Record last verified: 2015-06

Locations

CA (1)