Stereotactic Radiation and OX40 in Patients With Breast Cancer Metastatic to the Liver or Lung (OX40 SBRT)
This study is currently recruiting participants.
Verified January 2013 by Providence Health & Services
Sponsor:
Providence Health & Services
Collaborator:
Safeway Foundation
Information provided by (Responsible Party):
Providence Health & Services
ClinicalTrials.gov Identifier:
NCT01642290
First received: July 2, 2012
Last updated: January 7, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer, Metastatic Malignant Neoplasm of Breast TNM Stage M1 |
Radiation: 15 Gy Radiation plus anti-OX40 Drug: anti-OX40 Radiation: 20 Gy radiation and anti-OX40 Radiation: 25 Gy radiation and anti-OX40 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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. |
Resource links provided by NLM:
Further study details as provided by Providence Health & Services:
Primary Outcome Measures:
- Change in blood tests, overall health or symptoms. [ Time Frame: Thirty-six days. ] [ Designated as safety issue: Yes ]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.
Secondary Outcome Measures:
- Estimate the response rate of combined modality treatment in both irradiated and non-irradiated tumors. [ Time Frame: Up to four years, depending on patient response to treatment ] [ Designated as safety issue: No ]Follow up after day 36 (the completion of the study) will be dictated by the clinical response. Patients achieving a radiographic response, or are stable, will be followed monthly with physical exam and laboratory studies with CT (or other imaging as deemed appropriate) scans will obtained every 3 months for up to 24 months and then ever 6 months for up to 4 years.
- Determine the influence of anti-OX40 and radiation on circulating CD4+ and CD8+ T cells. [ Time Frame: Depending on patient response, up to 4 years. ] [ Designated as safety issue: No ]Blood samples will be collected from peripheral access for immune monitoring at Days, 2, 3, 5, 8, 15, 29, and 36. During the follow-up period, every 3 months for up to 24 months and then ever 6 months for up to 4 years.
| Estimated Enrollment: | 38 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cohort 1
Cohort 1 will receive a single fraction of stereotactic body radiation at a level of 15 Gy. Patient will receive doses of anti-OX40 on Days 1, 3, and 5.
|
Radiation: 15 Gy Radiation plus anti-OX40
Patients receive a single fraction of radiation on Day 1 (15Gy) and receive .4mg/kg of anti-OX40 on Days 1, 3, and 5.
Drug: anti-OX40
anti-OX40 given at .4mg/kg on Days 1, 3, and 5
|
|
Experimental: Cohort 2
Cohort 2 will receive a single fraction of stereotactic body radiation at a level of 20 Gy. Patient will receive doses of anti-OX40 on Days 1, 3, and 5.
|
Drug: anti-OX40
anti-OX40 given at .4mg/kg on Days 1, 3, and 5
Radiation: 20 Gy radiation and anti-OX40
Patients receive a single fraction of radiation on Day 1 (20 Gy) and receive .4mg/kg of anti-OX40 on Days 1, 3, and 5.
|
|
Experimental: Cohort 3
Cohort 3 will receive a single fraction of stereotactic body radiation at a level of 25 Gy. Patient will receive doses of anti-OX40 on Days 1, 3, and 5.
|
Drug: anti-OX40
anti-OX40 given at .4mg/kg on Days 1, 3, and 5
Radiation: 25 Gy radiation and anti-OX40
Patients receive a single fraction of radiation on Day 1 (25 Gy) and receive .4mg/kg of anti-OX40 on Days 1, 3, and 5.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01642290
Contacts
| Contact: Marka Crittenden, MD | 503-215-6029 | marka.crittenden@providence.org |
| Contact: Katie Strauss, RN | 503-215-2619 | katie.strauss@providence.org |
Locations
| United States, Oregon | |
| Providence Portland Medical Center | Recruiting |
| Portland, Oregon, United States, 97213 | |
| Contact: Katie Strauss, RN 503-215-2619 katie.strauss@providence.org | |
| Contact: Marka Crittenden, MD 503-215-3928 marka.crittenden@providence.org | |
| Principal Investigator: Mark Crittenden, MD | |
| Sub-Investigator: Steven Seung, MD | |
| Sub-Investigator: Brendan Curti, MD | |
| Sub-Investigator: Alison Conlin, MD | |
| Sub-Investigator: Steve Bader, MD | |
| Sub-Investigator: Christine Cha, MD | |
| Sub-Investigator: Todd Crocenzi, MD | |
| Sub-Investigator: Rachel Sanborn, MD | |
| Sub-Investigator: Matthew Solhjem, MD | |
| Sub-Investigator: Walter J. Urba, MD | |
| Sub-Investigator: Alice Wang-Chesbro, MD | |
| Sub-Investigator: John W. Smith, MD | |
| Sub-Investigator: Katie Strauss, RN | |
Sponsors and Collaborators
Providence Health & Services
Safeway Foundation
Investigators
| Principal Investigator: | Marka Crittenden, MD | Earle A Chiles Research Institute at Providence Portland Medical Center |
More Information
No publications provided
| Responsible Party: | Providence Health & Services |
| ClinicalTrials.gov Identifier: | NCT01642290 History of Changes |
| Other Study ID Numbers: | EACRI 12-017A |
| Study First Received: | July 2, 2012 |
| Last Updated: | January 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Providence Health & Services:
|
Stereotactic Body Radiation anti-OX40 Breast Cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013