A Single-Arm, Open-Label Study of Intralesional Treatment of Laryngeal Squamous Cell Carcinoma With Cisplatin
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Overall Pathologic Response Rate (OPRR)
研究概览
简要总结
The purpose of this study is to determine the effects, good and bad, of injecting chemotherapy into recurrent laryngeal squamous cell carcinoma (SCC) tumors.
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
- •Men and women 18 years and older.
- •Previously treated for laryngeal SCC with radiation.
- •Must have biopsy-proven recurrent cancer requiring surgical management. Note: if participants do not have an archived tissue sample available for review, they may undergo a biopsy procedure for collection of a fresh tissue sample for diagnostic confirmation and determination of further treatment. In this case, a fresh tumor sample would be used for diagnostic confirmation and trial eligibility. Please note, this biopsy would be considered a standard of care (SOC) procedure since it is being performed for disease management purposes regardless of participant enrollment in the trial.
- •Participants must be willing to undergo 3 weekly cycles of IC under local anesthesia prior to surgery.
- •Adequate hematologic, hepatic, and renal function tested within 6 weeks prior to the start of therapy (values must not be achieved with growth factors):
- •Absolute neutrophil count (ANC) ≥ 1.0 × 10^9 cells /L.
- •Hemoglobin ≥ 8.0 g/dL.
- •Platelet count ≥ 50 × 10^9 platelets/L.
- •Total bilirubin ≤ 1.5 × upper limit of normal (ULN).
- •Alanine transaminase (ALT)/aspartate aminotransferase (AST) ≤ 3.0 ULN.
- •Calculated creatinine clearance ≥ 45 mL/min by the Cockcroft-Gault Equation or the estimated glomerular filtration rate ≥ 45 mL/min/1.73 m2 using the Modification of Diet in Renal Disease formula.
- •Willingness to avoid pregnancy based on the criteria below:
- •Woman of non-childbearing potential (ie, surgically sterile with a hysterectomy and/or bilateral oophorectomy OR ≥ 12 months of amenorrhea and at least 45 years of age).
- •Woman of childbearing potential who has a negative urine or serum pregnancy test at screening and who agrees to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening and for at least 14 months after the last dose of trial intervention. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participant and their understanding confirmed.
排除标准
- •Inability to tolerate awake, unsedated laryngeal procedures. Participants may opt to receive pre-procedure diazepam.
- •Participant unable to receive contrast.
- •Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
- •Receipt of anticancer medications or investigational drugs within the following intervals before the date of the first dose of trial intervention:
- •< 10 weeks from completion of any radio- or toxin-immunoconjugates.
- •< 4 weeks for immunotherapy.
- •< 3 weeks for radiotherapy.
- •< 2 weeks for any investigational agent or other anticancer medications.
- •Steroids that are used for treatment of allergy or other underlying condition are permittable but not steroids started to treat cancer. Individuals receiving corticosteroids must be at a dose level ≤ 10 mg/day within 7 days of the trial intervention administration.
- •Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.
- •Current or previous other malignancy within 3 years of trial entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy.
- •Significant concurrent, uncontrolled medical condition, including, but not limited to, renal, hepatic, hematological, gastrointestinal (GI), endocrine, pulmonary, neurological, cerebral, or psychiatric disease.
- •Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment or exposure to a live vaccine within 30 days of dosing.
- •Known human immunodeficiency virus (HIV) infection or positivity on immunoassay. Note: HIV screening test is optional.
- •Current New York Heart Association Class II to IV congestive heart failure.
- •Uncontrolled or symptomatic arrhythmia or stroke in last 6 months, liver cirrhosis, or autoimmune disorder requiring immunosuppression or long-term corticosteroids (> 10 mg daily prednisone equivalent).
- •Currently pregnant or breastfeeding.
- •Any condition that would, in the Investigator's judgment, interfere with full participation in the trial, including administration of trial intervention and attending required trial visits; pose a significant risk to the patient; or interfere with interpretation of trial data.
- •Patients with impaired decision-making capacity.
研究组 & 干预措施
Cisplatin + Epinephrine Group
Participants in this group will receive one (1) dose of intralesional chemotherapy (IC) treatment per week over a period of approximately 3 weeks. IC treatment will consist of combination cisplatin and epinephrine. Participants will then go to have endoscopic surgery for their disease.
Total participation duration is approximately 16 months.
干预措施: Epinephrine injection (Drug)
Cisplatin + Epinephrine Group
Participants in this group will receive one (1) dose of intralesional chemotherapy (IC) treatment per week over a period of approximately 3 weeks. IC treatment will consist of combination cisplatin and epinephrine. Participants will then go to have endoscopic surgery for their disease.
Total participation duration is approximately 16 months.
干预措施: Laryngeal Biopsy (Procedure)
Cisplatin + Epinephrine Group
Participants in this group will receive one (1) dose of intralesional chemotherapy (IC) treatment per week over a period of approximately 3 weeks. IC treatment will consist of combination cisplatin and epinephrine. Participants will then go to have endoscopic surgery for their disease.
Total participation duration is approximately 16 months.
干预措施: Endoscopic Surgery (Procedure)
Cisplatin + Epinephrine Group
Participants in this group will receive one (1) dose of intralesional chemotherapy (IC) treatment per week over a period of approximately 3 weeks. IC treatment will consist of combination cisplatin and epinephrine. Participants will then go to have endoscopic surgery for their disease.
Total participation duration is approximately 16 months.
干预措施: Cisplatin (Drug)
结局指标
主要结局
Overall Pathologic Response Rate (OPRR)
时间窗: About six (6) weeks
Overall Pathologic Response Rate (OPRR) is defined as the number of participants with a complete response (CR) or partial response (PR) as the best response to intralesional chemotherapy (IC) treatment. ORRR will be assessed by pathology as percentage viable tumor on histopathology at time of surgical resection.
次要结局
- Number of Participants Experiencing Treatment-Related Serious Adverse Events (SAEs)(About 18 weeks)
- Number of Participants Experiencing Treatment-Related Adverse Events (AEs)(About 18 weeks)
- Overall Radiographic Response Rate (ORRR)(About five (5) weeks)
- Overall Endoscopic Response Rate (OERR)(About five (5) weeks)
研究者
David Rosow
Professor of Clinical
University of Miami