Stereotactic Radiation and OX40 in Patients With Breast Cancer Metastatic to the Liver or Lung
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/28/2013 |
| Start Date: | February 2012 |
| End Date: | January 2016 |
| Contact: | Marka Crittenden, MD |
| Email: | marka.crittenden@providence.org |
| Phone: | 503-215-6029 |
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 study for patients with progressive metastatic breast cancer following systemic
therapy who have lesions on the lungs or liver. The study is designed to find the maximum
dose of radiation that can be given with anti-OX40.
therapy who have lesions on the lungs or liver. The study is designed to find the maximum
dose of radiation that can be given with anti-OX40.
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.
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
We found this trial at
1
site
4805 Northeast Glisan Street
Portland, Oregon 97213
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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