Therapeutic Drug Screening Using a Novel Implantable Microdevice (IMD) in Head and Neck Cancers: a Window of Opportunity Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Grade 3 or Higher Treatment-Related Toxicity Rate
研究概览
简要总结
This research study is studying the effect of different drugs as possible treatments for salivary and other head and neck cancers/
The name of the study intervention involved in this study is:
-- implantable microdevice
详细描述
This window-of-opportunity pilot study will assess the safety and feasibility of using an implantable microdevice (IMD) to efficiently measure local intratumor response to multiple drugs within previously untreated head and neck cancer patients undergoing definitive oncologic resection.
- This research study is a Pilot Study, which is the first-time investigators are examining this study device in salivary and head and neck cancers. The placement and removal of the microdevice is being tested for the first time in this type of cancer.
- This research study involves drugs that are released by a small implantable microdevice (IMD) as small as the tip of a needle, that is inserted into the tumor and is then removed 3-5 days later during surgery.
- The microdevice can hold up to 20 drugs alone or in combinations in very small concentrations that are able to access the cancer through small pores in the device. When the device is removed along with the cancer at the time of surgery, it will be evaluated to understand which drug(s) may be effective to treat these cancers.
It is expected that about 30 people will take part in this research study.
The U.S. Food and Drug Administration (FDA) has not approved the microdevice a treatment for any disease.
AACRF, a research foundation, is supporting this research study by providing funding for the research study, the study drugs and study procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have histologically confirmed head and neck cancer (salivary or ACC type, or squamous cell carcinoma) without evidence of recurrent, metastatic or advanced, incurable disease undergoing definitive surgical management; any stage disease is permitted (American Joint Committee on Cancer 2017 8th edition).
- •Age 18 years or older.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •A measurable primary tumor site both clinically and radiologically measuring at least 1 x 1 cm.
- •- Patients must be deemed medically fit to undergo both percutaneous and surgical procedures by their treating head and neck surgeon and medical oncologist.
- •Participants will undergo laboratory testing within 7 days prior to the microdevice placement: they are required to have a platelet count ≥50,000/mcL, PT/INR <2, and aPTT <1.5x upper limit of normal.
- •Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 14 days
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Participants who are receiving any other investigational agents.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit the safety of a biopsy and/or surgery.
- •Pregnant women are excluded from this study because of the possible increased dose of radiation from imaging associated with the device placement and the potential risk to the pregnancy of the surgery/device placement.
- •Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or percutaneous biopsy procedures. If the patient is on systemic anticoagulation, this should be discussed with the overall PI and treating surgeon
研究组 & 干预措施
IMD PLACEMENT + SURGICAL RESECTION + ADJUVANT TREATMENT ARM
Newly diagnosed, localized head and neck cancers undergoing surgical resection
- Interventional radiology guided IMD placement
- Planned oncologic resection with IMD retrieval 3-5 days after placement
- Standard of care adjuvant treatment
- Tumor specimen analysis for local drug response and molecular analysis
干预措施: Implantable Microdevice (IMD) (Combination Product)
结局指标
主要结局
Grade 3 or Higher Treatment-Related Toxicity Rate
时间窗: AE assessed on post-operative visit, which take placed between 7-14 days after the surgical procedure.
All grade 3 or higher adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv5 as reported on case report forms were counted. Rate is the proportion of treated participants experiencing at least one treatment-related grade 3 or higher AE of any type during the time of observation.
次要结局
- Pharmacodynamic (PD)(Screening Period 1 day)
- Changes in Tumor Metabolism(through study completion, an average of 1 year)
- Evaluate the likelihood of independent drug or combination response/failure in this pilot population to determine the appropriateness of nominating therapies for further clinical investigation(through study completion, an average of 1 year)
- Tumor Response(through study completion, an average of 1 year)
- Biomarker levels(through study completion, an average of 1 year)
- Gene Expression Level(through study completion, an average of 1 year)
研究者
Glenn J. Hanna, M.D.
Principal Investigator
Dana-Farber Cancer Institute