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Talimogene Laherparepvec (T-VEC) for Breast Cancer Local Recurrence

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT02658812
First received: January 14, 2016
Last updated: June 29, 2017
Last verified: June 2017
  Purpose
The goal of this clinical research study is to learn if talimogene laherparepvec can help to control recurrent (has come back after treatment) breast cancer. The safety of this drug will also be studied.

Condition Intervention Phase
Breast Cancer Drug: Talimogene Laherparepvec (T-VEC) Other: Photographs Behavioral: Follow-Up Visit/Phone Call Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Disease Control Rate [ Time Frame: Disease assessments performed up to cycle 10 (approximately 6 months) ]
    Disease control rate defined as the percentage of complete response (CR), partial response (PR) or stable disease in overall patients. Response evaluated using RECIST ver.1.1. Disease assessment will be performed at the end of cycle 4, cycle 8 and cycle 10.


Secondary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: From beginning of treatment to disease progression or death, up to 1 year ]
    Definition of PFS is time from treatment initiation until disease progression or death, with progression confirmed after the end of cycle 10.


Estimated Enrollment: 35
Actual Study Start Date: August 2016
Estimated Study Completion Date: August 2021
Estimated Primary Completion Date: August 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Talimogene Laherparepvec (T-VEC)

Talimogene laherparepvec given via intra-tumoral injection at visible locally recurrent breast cancer site and skin metastases at an initial dose of 10^6 PFU/mL .

Second talimogene laherparepvec dose administered 10^8 PFU/mL on Day 22, and talimogene laherparepvec administered every 2 weeks after the second course with same dose with the maximum dose of 4.0 mL for each course.

Drug: Talimogene Laherparepvec (T-VEC)

Talimogene laherparepvec given via intra-tumoral injection at visible locally recurrent breast cancer site and skin metastases at an initial dose of 10^6 PFU/mL .

Second talimogene laherparepvec dose administered 10^8 PFU/mL on Day 22, and talimogene laherparepvec administered every 2 weeks after the second course with same dose with the maximum dose of 4.0 mL for each course.

Other Names:
  • T-VEC
  • OncoVEX GM-CSF
Other: Photographs
Photographs taken of lesions on chest at baseline, at Cycle 2, Cycles 4, 8, and 10 if the doctor thinks it is needed, Day 1 of Cycle 5, Day 1 of Cycle 7, and then every odd numbered cycle after that.
Behavioral: Follow-Up Visit/Phone Call
About 30 days after end-of-treatment visit and then every 3 months after that for up to 1 year, participant has follow-up visit or phone call from study staff.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histological confirmation of breast carcinoma.
  2. Histological confirmation of recurrence of chest wall with or without distant metastasis disease.
  3. Patients may have any molecular status (ER, PR and HER2) and must have failed at least 1 systemic regimen after their diagnosis of locoregional disease
  4. Previous adjuvant endocrine therapy for initial breast cancer was allowed but had to be discontinued at least 1 week before receiving the study drug.
  5. Previous chemotherapy for local recurrence is allowed but must have been discontinued at least 4 weeks before receiving the study drug and the patient must have recovered from acute adverse effects.
  6. Previous radiation therapy was allowed but must have been discontinued at least 2 months before study drug is administered, and the patient must have recovered from acute toxic effects.
  7. Age >=18 years old
  8. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1
  9. Adequate hematologic function: 1).Absolute neutrophil count (ANC) >= 1.5x109/L; 2).Platelet count >= 100x109/L; 3).Hemoglobin >=10.0 g/L. 4).International normalization ratio (INR) or prothrombin time (PT) 1.5 x 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
  10. Adequate renal function: Calculated creatinine clearance > 30 ml/min
  11. Adequate Hepatic function: a).Aspartate aminotransferase (AST) <= 2.5 x ULN; b).Alanine aminotransferase (ALT) <= 2.5 x ULN; c).Total bilirubin <= 1.5 x ULN.
  12. 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.
  13. Female patients of childbearing potential must have negative urine or serum pregnancy test no more than 3 days prior to starting study treatment.
  14. Patients must be able and willing to give written informed consent.

Exclusion Criteria:

  1. Patients who have operable disease with curable intent, and/or are candidates for radiation therapy for local control.
  2. Patients receiving concurrent anti-cancer therapy (chemotherapy, immunotherapy, radiation therapy, hormonal therapy, and biological therapy) while taking study medication, or have previously received .talimogene laherparepvec or any other oncolytic virus.
  3. Patients with metastatic sites that requires chemotherapy and/or non-hormonal targeted therapy.
  4. 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
  5. More than three lesions per organ for visceral metastases except for lung or lymph node sites.
  6. History or evidence of symptomatic autoimmune disease (eg, pneumonitis, glomerulonephritis, vasculitis, or other), or history of active autoimmune disease that has required systemic treatment (ie, use of corticosteroids, immunosuppressive drugs or biological agents used for treatment of autoimmune diseases) in past 2 months prior to enrollment. 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.
  7. 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
  8. History of a second cancer, except treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancers for which patients are disease free for at least 3 years.
  9. Patients with initial diagnoses of stage IV disease.
  10. Patients with active infection and requiring IV or oral antibiotics
  11. Evidence of immune suppression due to: a) Known human immunodeficiency virus (HIV) infection or AIDS; b) Known leukemia or lymphoma; c) Those who require high dose steroids or other immunosuppressive agents; d) Known hepatitis B or C infection; e) Congenital or acquired cellular and/or humoral immune deficiency; f) other signs or symptoms of immune system suppression
  12. Active herpetic skin lesions or prior complication of HSV-1 infections (e.g. herpetic encephalitis or keratitis).
  13. Currently pregnant or breast-feeding, or planning to become pregnant during study treatment and through 3 months after the last dose of study treatment.
  14. Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 3 months after the last dose of talimogene laherparepvec. (Women of not childbearing potential: post-menopausal [age > 55 years with cessation of menses > 12 months or < 55 years but not spontaneous menses for at least 2 years or < 55 years and spontaneous menses within the past 1 year, but currently amenorrheic (eg, spontaneous or secondary to hysterectomy), and with postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating hormone levels > 40 IU/L) or postmenopausal estradiol levels (< 5 ng/dL) or according to the definition of "postmenopausal range" for the laboratory involved] or who have had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy).
  15. Sexually active subjects and their partners unwilling to use male or female latex condom to avoid potential viral transmission during sexual contact while on treatment and within 30 days after treatment with talimogene laherparepvec.
  16. Currently enrolled in another clinical trial (exclude non-cancer treatment trail) or received an investigational agent within 4 weeks of study initiation
  17. Requires intermittent or chronic treatment with antiherpetic drugs, except for topical agents
  18. Patients who is known sensitive to any of the products or components to be administered during treatment with talimogene laherparepvec.
  19. Chronic oral or systemic steroid medication use at a dose of >10 mg/d of prednisone or equivalent [steroids with low systemic absorption (e.g. triamcinolone hexacetonide) injected into joint space are allowed]
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02658812

Contacts
Contact: Naoto Ueno, MD, PHD 713-792-2817

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: MD Anderson Health Information Specialist    877-632-6789      
Sponsors and Collaborators
M.D. Anderson Cancer Center
Amgen
Investigators
Principal Investigator: Naoto Ueno, MD, PHD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02658812     History of Changes
Other Study ID Numbers: 2014-0034
NCI-2016-00199 ( Registry Identifier: NCI CTRP )
Study First Received: January 14, 2016
Last Updated: June 29, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Inflammatory breast cancer
IBC
Non-inflammatory breast cancer
Inoperable local recurrence
Talimogene laherparepvec
T-VEC
OncoVEX GM-CSF

Additional relevant MeSH terms:
Breast Neoplasms
Recurrence
Inflammatory Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 25, 2017