Nüks Eden veya Metastatik Baş-Boyun Yassı Hücreli Kanseri ya da Metastatik Meme Kanseri Hastalarının Tedavisinde Viral Terapi

Sade dilde özet

Bu çalışma, nüks etmiş veya metastatik baş-boyun yassı hücreli kanser ya da metastatik meme kanseri hastalarında, genetiği değiştirilmiş kızamık virüsünü (kanser hücrelerini hedefleyen onkolitik virüs) inceliyor. Standart tedavisi küratif olmayan, doğrulanmış hastalar dahil edilmiştir. Faz 1 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 1 (Phase 1)

Durum

Tamamlandı

Sponsor

Mayo Clinic

Müdahale

Laboratory Biomarker Analysis, Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter

Başlangıç

09.04.2013

Tahmini bitiş

26.11.2019

Ülkeler

United States

İlgili genler

Merkezler

• Rochester, United States

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Pathologically confirmed squamous cell carcinoma of the head and neck OR pathologically confirmed invasive breast adenocarcinoma with documented estrogen receptor (ER)/progesterone receptor (PR)/human epidermal growth factor receptor 2 (HER2) status and radiographic evidence of distant metastatic disease
* Measurable disease
* Head and neck cancer OR metastatic breast for which standard therapy is not curative \*NOTE: Patients with ER/PR positive, HER2 negative breast cancer must have progressed through at least one prior cytotoxic regimen for advanced disease and no longer be candidates for standard endocrine therapy; patients with HER2 positive breast cancer irrespective of ER/PR status must have received or no longer be candidates for standard HER2 directed therapy (i.e., trastuzumab, pertuzumab, trastuzumab emtansine, and lapatinib); patients with ER/PR/HER2 negative breast cancer must have progressed through at least one prior cytotoxic regimen for advanced disease; ER/PR and HER2 status are defined by current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
* Patient may have more than one site of recurrence/metastatic disease but only one lesion will be injected that is \>= 1 cm in size (if in the lung, the lesion must be \>= 2 cm and adjacent to the pleura in the lung)
* Absolute neutrophil count (ANC) \>= 1500
* Platelet (PLT) \>= 100,000
* Hemoglobin (HgB) \> 9.0 g/dL
* Total bilirubin =\< institutional upper limit of normal (ULN)
* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =\< 1.5 x ULN
* Creatinine =\< 1.0 mg/dL
* Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
* Provide informed written consent
* Willingness to return to Mayo Clinic enrolling institution for follow-up
* Willingness to provide biologic samples for correlative research purposes
* Life expectancy \>= 12 weeks

Exclusion Criteria:

* Any of the following \* Pregnant women \* Nursing women \* Men or women of childbearing potential who are unwilling to employ adequate contraception during treatment and 8 weeks following the completion of treatment
* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
* Receiving therapeutic anticoagulation (Coumadin or low molecular weight heparin)
* Active infection =\< 5 days prior to registration
* History of tuberculosis or history of tuberculin purified protein derivative (PPD) positivity
* Any of the following prior therapies: \* Chemotherapy =\< 3 weeks prior to registration \* Immunotherapy =\< 4 weeks prior to registration \* Biologic therapy =\< 4 weeks prior to registration \* Radiation therapy =\< 3 weeks prior to registration
* Failure to fully recover from acute, reversible effects defined as =\< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0 of prior chemotherapy regardless of interval since last treatment
* Requiring blood product support
* Central nervous system (CNS) metastases or seizure disorder
* Human immunodeficiency virus (HIV)-positive test result, or history of other immunodeficiency
* History of organ transplantation
* History of chronic hepatitis B or C
* Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration \[FDA\] approved indication and in the context of a research investigation)
* Treatment with oral/systemic corticosteroids, with the exception of topical or inhaled steroids
* Current exposure to household contacts =\< 15 months old or household contact with known immunodeficiency
* Willing to avoid household contacts =\< 15 months old or household contact with known immunodeficiency 1 week after treatment
* Allergy to measles vaccine or history of severe reaction to prior measles vaccination
* Allergy to iodine; Note: this does not include reactions to intravenous contrast materials