Talimogene Laherparepvec in Treating Patients With Recurrent Breast Cancer That Cannot Be Removed by Surgery
|ClinicalTrials.gov Identifier: NCT02658812|
Recruitment Status : Active, not recruiting
First Posted : January 20, 2016
Last Update Posted : November 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Malignant Chest Wall Neoplasm Recurrent Breast Carcinoma Recurrent Inflammatory Breast Carcinoma Stage IV Breast Cancer AJCC v6 and v7 Stage IV Inflammatory Breast Carcinoma||Other: Laboratory Biomarker Analysis Biological: Talimogene Laherparepvec||Phase 2|
I. To determine the efficacy of talimogene laherparepvec in inflammatory breast cancer or non-inflammatory breast cancer patients with inoperable local recurrence measured by the overall response rate.
I. To determine the efficacy of talimogene laherparepvec in inflammatory breast cancer or non-inflammatory breast cancer patients with inoperable local recurrence measured by the overall disease control rate.
II. To determine the rate of local overall response and disease control rate, progression-free survival (PFS), and overall survival (OS) in all patients.
III. To determine the rate of local overall response and disease control rate, PFS, and OS in patients without distant metastases.
IV. To determine the rate of local overall response and disease control rate, PFS, and OS in patients with distant metastases.
V. To determine the safety of talimogene laherparepvec injection to local disease.
I. To determine the effect of talimogene laherparepvec on injection sites and distant metastatic sites by evaluating immune function and apoptosis with immune cell surface markers and cytokines.
II. To assess changes in the following: serum or plasma levels of interleukin (IL)-2, IL-12, tumor necrosis factor (TNF)-alpha, and interferon (IFN)- alpha; (Reuben's Lab); phenotype for T-cell subsets (CD3, CD4, CD8, CD25) and natural killer cell (NK-cell) subsets (CD16, CD56), which will be determined via multiparameter fluorescence-activated cell sorting (FACS) analysis (percentage and absolute numbers) in peripheral blood at Dr. James Reuben's laboratory of MD Anderson; serum analysis of herpes simplex virus (HSV) type 1 serology with immunoglobulin (Ig)G and IgM (enzyme-linked immunosorbent assay [ELISA]).
III. To assess distant tumor tissue changes by evaluating necrosis and immune cell infiltration (T-/B-/NK-Cell, macrophage, dendritic cell) by immunohistochemistry assay (CD3, CD4, CD8, CD20, CD16, CD56, granzyme B, cleaved caspase 3, and Ki-67) when distant tumor sample is obtained; if the sample volume is ample, additional immunohistochemistry assays will be performed for CD45RO, TIA-1, FoxP3, CD25, OX-40, CD57, CD1a, CD208, myeloperoxidase, CD68, COX-2, major histocompatibility complex (MHC) class I and MHC class II in Dr. Savitri Krishnamurthy's laboratory at MD Anderson.
Patients receive talimogene laherparepvec intratumorally (IT) on day 1. Courses repeat every 3 weeks in course 1 and every 2 weeks thereafter in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 3 months for up to 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Using Talimogene Laherparepvec as a Single Agent for Inflammatory Breast Cancer (IBC) or Non-IBC Patients With Inoperable Local Recurrence|
|Actual Study Start Date :||August 1, 2016|
|Estimated Primary Completion Date :||August 1, 2021|
|Estimated Study Completion Date :||August 1, 2021|
Experimental: Treatment (talimogene laherparepvec)
Patients receive talimogene laherparepvec IT on day 1. Courses repeat every 3 weeks in course 1 and every 2 weeks thereafter in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Biological: Talimogene Laherparepvec
- Overall response rate defined as the percentage of complete response, partial response in overall patients [ Time Frame: Up to 5 months ]The trial will be conducted using a two-stage design and the overall response rate will be estimated accordingly.
- Overall disease control rate [ Time Frame: Up to 1 year ]
- Local overall response rate [ Time Frame: Up to 1 year ]
- Local disease control rate [ Time Frame: Up to 1 year ]
- Progression-free survival [ Time Frame: Up to 1 year ]
- Overall survival [ Time Frame: Up to 1 year ]
- Incidence of adverse events [ Time Frame: Up to 1 year ]Will be evaluated according to Common Terminology Criteria for Adverse Events version 4.0.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658812
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Naoto Ueno||M.D. Anderson Cancer Center|