Know Cancer

or
forgot password

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.


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Metastatic, Malignant Neoplasm of Breast TNM Stage M1

Thank you

Trial Information

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.


This is a phase I/II study to determine the maximum tolerated dose of stereotactic body
radiation given with anti-OX40. Three different dose levels of radiation will be tested.
All patients will receive three doses of anti-OX40 given over a 60 minute IV infusion. Up to
18 patients will be treated during the dose escalation phase, and an additional 20 at the
maximum tolerated dose.


Inclusion Criteria:



- Stage 4 histologically confirmed breast cancer

- At least 1 lesion in the liver or lung amenable to SBRT

- 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.

- ECOG performance status of 0, 1, or 2

- Anticipated life span greater than 12 weeks

Exclusion Criteria:

- Active infection

- Active autoimmune disease

- Previous treatment with mouse monoclonal antibodies

- Brain metastatic disease

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in blood tests, overall health or symptoms.

Outcome Description:

Patients will have radiation therapy and anti-OX40 on Day 1. Patients return to clinic on Days 2, 3, 5, 8, 15, 29 and 36 for blood tests and adverse event evaluations. Changes in blood tests that may represent a dose limiting toxicity will be evaluated. Changes in overall health or symptoms that may represent a dose-limiting drug side effect will be evaluated.

Outcome Time Frame:

Thirty-six days.

Safety Issue:

Yes

Principal Investigator

Marka Crittenden, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Earle A Chiles Research Institute at Providence Portland Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

EACRI 12-017A

NCT ID:

NCT01642290

Start Date:

February 2012

Completion Date:

January 2016

Related Keywords:

  • Breast Cancer, Metastatic
  • Malignant Neoplasm of Breast TNM Stage M1
  • Stereotactic Body Radiation
  • anti-OX40
  • Breast Cancer
  • Breast Neoplasms
  • Neoplasms

Name

Location

Providence Portland Medical CenterPortland, Oregon  97213-3635