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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
Metastatic Breast Cancer, Lung Metastases, Liver Metastases

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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.


Inclusion Criteria:



- Histologically confirmed breast cancer with clinical evidence of stage 4 disease

- Measurable disease and at least one lesion in either liver or lung that is amenable
to stereotactic body radiation

- One site of disease that will not receive radiation

- 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.

- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.

- Women of childbearing potential must have a negative pregnancy test on the day
treatment starts and must avoid becoming pregnant while on treatment. Men must avoid
fathering a child while on treatment.

- Patients must have blood test results within pre-specified range

- No active bleeding

- No clinical coagulopathy (INR <1.5, PT <16 seconds, PTT < 38 seconds) within 28 days

- Anticipated lifespan greater than 12 weeks

Exclusion Criteria:

- Active infection requiring systemic antibiotics.

- Active autoimmune disease as defined by the autoimmune disease assessment tool.

- Previous treatment with mouse monoclonal antibodies

- At least 28 days since prior chemotherapy or monoclonal antibody therapy (trastuzumab
or bevacizumab). Patients who have been on hormonal therapy can continue on therapy
at the discretion of the investigator. Bisphosphonate therapy is acceptable during
study participation.

- Diagnosis of a solid tumor malignancy (excluding non-melanoma skin cancer) within 3
years of enrollment.

- Need for chronic maintenance oral steroids.

- Active brain metastatic disease. Treated brain metastases with surgery, gamma-knife
radiosurgery or radiation and stable for at least 4 weeks and off steroids are
eligible.

- No metastatic site amenable to SBRT

- Pregnant or lactating women, as treatment involves risks to the embryo or fetus.

- Other medical or psychiatric conditions that in the opinion of the Principal
Investigator would preclude safe participation in protocol.

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:

Determine the maximum tolerated dose and safety profile of radiation administered in combination with anti-OX40 in patients with metastatic breast cancer.

Outcome Description:

A dose limiting toxicity (DLT) is defined as any greater than or equal to grade 3 non-hematologic toxicity (except hypothyroidism or vitiligo) that in the opinion of the investigator is considered at least possibly related to treatment. Grade 3 or 4 hematologic toxicities that take longer than 10 days to resolve will be considered DLTs. Patients will have 8 clinic visits over 36 days to identify toxicities.

Outcome Time Frame:

From Day 1 to Day 36

Safety Issue:

Yes

Principal Investigator

Marka R Crittenden, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Providence Cancer Center, Earle A. Chiles Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

12-017A

NCT ID:

NCT01862900

Start Date:

February 2013

Completion Date:

February 2023

Related Keywords:

  • Metastatic Breast Cancer
  • Lung Metastases
  • Liver Metastases
  • Breast Cancer
  • Metastatic
  • Lung metastases
  • Liver metastases
  • Stereotactic body radiation
  • anti-OX40 antibody
  • Breast Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Lung Neoplasms
  • Liver Neoplasms

Name

Location

Portland Providence Medical Center Portland, Oregon  97213