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.
18 Years
N/A
Both
Breast Cancer, Metastatic, Malignant Neoplasm of Breast TNM Stage M1
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 Center | Portland, Oregon 97213-3635 |
