Talimogene Laherparepvec in Treating Patients With Recurrent Breast Cancer That Cannot Be Removed by Surgery

NCT02658812 | Terminated Phase 2 Results FDA Drug

• 3 other identifiers: 2014-0034NCI-2016-00199P30CA016672
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well talimogene laherparepvec works in treating patients with breast cancer that has come back and cannot be removed by surgery. Biological therapies, such as talimogene laherparepvec, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing.

Conditions

Malignant Chest Wall Neoplasm; Recurrent Breast Carcinoma; Recurrent Inflammatory Breast Carcinoma; Stage IV Breast Cancer AJCC v6 and v7; Stage IV Inflammatory Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Overall Response Rate (ORR)

  Overall Response Rate defined as the rate of patients who achieved a partial response or complete response as the best response for the measurable and nonmeasurable disease. Evaluated using RECIST ver.1.1. Complete Response (CR): Disappearance of all target and non-target lesions at a minimum of 4 weeks. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of the target lesions at a minimum of 4 weeks, taking as a reference the baseline sum of the longest diameter with target.

  at the end of cycle 4 , cycle 8, and cycle 10, up to 5 months

Secondary Outcomes (3)

• Median Progression-Free Survival

  Time from treatment initiation until disease progression, uncontrolled disease progression or death. Maximum PFS follow-up for this study cohort was 3.9 months.

• Median Overall Survival

  From the date of treatment initiation until 1 year after removal from the study or until death, whichever occurs first

• Number of Adverse Events

  before each cycle and 30 days after the last dose of trial treatment or before the initiation of a new anti-cancer treatment, whichever comes first

Study Arms (1)

Treatment (talimogene laherparepvec)

EXPERIMENTAL

Patients receive talimogene laherparepvec IT on day 1. Cycles repeat every 3 weeks in cycle 1 and every 2 weeks thereafter in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker Analysis; Biological: Talimogene Laherparepvec

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (talimogene laherparepvec)

Talimogene Laherparepvec BIOLOGICAL

Given IT

Also known as: ICP34.5-, ICP47-deleted Herpes Simplex Virus 1 (HSV-1) Incorporating the Human GM-CSF Gene, Imlygic, JS1 34.5-hGMCSF 47- pA-, T-VEC

Treatment (talimogene laherparepvec)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological confirmation of breast carcinoma
• Histological confirmation of recurrence of chest wall with or without distant metastasis disease
• Patients must have failed at least 1 systemic regimen or have clinical stable disease with capecitabine, hormonal therapy (with or without mTOR inhibitor or CDK4/6 inhibitor), or anti HER-2 therapy (trastuzumab, pertuzumab, ado-trastuzumab emtansine, lapatinib) for at least 2 months after their diagnosis of locoregional/metastatic disease
• Concurrent radiation therapy is permitted after the study treatment is initiated so long as the planned radiation field doesn't overlap with planned injection sites
• Eastern cooperative oncology group performance status (ECOG PS) 0-1
• Absolute neutrophil count (ANC) \>= 1.0 x 10\^9/L; if patient is taking CDK4/6 inhibitor or capecitabine, there is a need for maintaining ANC \>= 1.0 consistently for at least 2 months without dose changes
• Platelet count \>= 75 x 10\^9/L, if patient is taking CDK4/6 inhibitor, ado-trastuzumab emtansine or capecitabine, there is a need for maintaining platelet count \>= 75 x 10\^9/L without dose changes
• Hemoglobin \>= 8.0 g/L
• International normalization ratio (INR) or prothrombin time (PT) 1.5 x upper limit of normal (ULN), unless the subject is receiving anticoagulant therapy, in which case PT and partial thromboplastin time (PTT)/ activated PTT (aPTT) must be within therapeutic range of intended use of anticoagulants
• Serum creatinine =\< 1.5 x upper limit of normal (ULN), OR 24-hour creatinine clearance \>= 60 mL/min for subject with creatinine levels \> 1.5 x ULN; (Note: creatinine clearance need not be determined if the baseline serum creatinine is =\< 1.5 x ULN; creatinine clearance should be determined per institutional standard)
• Aspartate aminotransferase (AST) =\< 2.5 x ULN if liver metastases present
• Alanine aminotransferase (ALT) =\< 2.5 x ULN if liver metastases present
• Total bilirubin =\< 1.5 x ULN, OR direct bilirubin =\< ULN for a subject with total bilirubin level \> 1.5 x ULN
• Subjects must be candidate for intralesional injection into cutaneous, subcutaneous or nodal tumors with or without image ultrasound guidance defined as one or more of the following at least 1 injectable lesion \>= 5 mm in longest diameter, multiple injectable lesions that in aggregate have a longest diameter of \>= 5 mm
• Female patients of childbearing potential must have negative urine pregnancy test no more than 3 days prior to starting study treatment

You may not qualify if:

• Patients who have operable disease with curable intent, and/or are candidates for radiation therapy for local control
• Patients receiving concurrent anti-cancer therapy (chemotherapy except capecitabine or ado-trastuzumab emtansine, immunotherapy) while taking study medication, or have previously received talimogene laherparepvec or any other oncolytic virus
• Patients with metastatic sites that requires chemotherapy (except capecitabine or ado-trastuzumab emtansine)
• Known active central nervous metastases; subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids \> 10 mg/day pf prednisone or equivalent; the exception does not include carcinomatosis meningitis which is excluded regardless of clinical stability
• More than three lesions per organ for visceral metastases except for lung or lymph node sites
• History or evidence of active autoimmune disease that has required systemic treatment (i.e., use of corticosteroids, immunosuppressive drugs or disease modifying agents); replacement therapy (eg, thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment for autoimmune disease
• Patients with concurrent disease or condition that would make them inappropriate for study participation, or any serious medical disorder that would interfere with patients' safety
• History of other malignancy within the past 5 years with the following exceptions: a) Adequately treated non melanoma skin cancer without evidence of disease at the time of enrollment b). Adequately treated cervical carcinoma in situ without evidence of disease at the time of enrollment c). Adequately treated breast ductal carcinoma in situ without evidence of disease at the time of enrollment d). Prostatic intraepithelial neoplasia without evidence of prostate cancer at the time of enrollment
• Patients with active infection and requiring intravenous (IV) or oral antibiotics
• Evidence of immune suppression as following:
• Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
• Known leukemia or lymphoma
• Primary immunodeficiency state such as severe combined immunodeficiency disease
• Concurrent opportunistic infection
• Receiving systemic immunosuppressive therapy (\> 2 weeks) including oral steroid doses \> 10 mg/day of prednisone or equivalent within 7 days prior to the initiation of study treatment

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Breast Neoplasms; Inflammatory Breast Neoplasms

Interventions

talimogene laherparepvec

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Naoto T. Ueno, MD-Professor Breast Medical Oncology
• Organization: UT MD Anderson Cancer Center

nueno@mdanderson.org

713-792-8754

Study Officials

• Naoto T Ueno

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: January 20, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 25, 2023
• Results First Posted: January 25, 2023

Record last verified: 2023-01

Locations

US (1)