Phase 1 Suicide Plus Immune Gene Therapy for Advanced Melanoma
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Safety reported as the number of treatment-related adverse events as assessed by CTCAE v4.03
研究概览
简要总结
Safety evaluation of combined immunogene therapy in patients with advanced melanoma.
详细描述
This phase I clinical protocol is proposed to evaluate the safety of combined immunotherapy genetics in humans.
This treatment combines the high local cytotoxicity of the suicide gene system (HSV thymidine kinase: HSVt k) / prodrug (ganciclovir: GCV) with the immunostimulation of interleukin2 (hIL2) and immunoamplification of granulocyte and macrophage colony stimulating factor (hGMCSF) in the presence of tumor antigens.
The proposed scheme consists in the periodic intra / peritumoral application of plasmid DNA complexes: cationic lipid (lipoplexes) containing the HSVtk gene, co-administered with the prodrug GCV, and subcutaneous injections of a vaccine (LGvax) produced with formolized extracts of allogeneic melanoma combined with lipoplexes carrying the hIL2 and hGMCSF genes.
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
- •Patients with histologically and / or cytologically confirmed melanoma.
- •Patients progressed or are intolerant to conventional systemic treatments.
- •Patients that are not candidates for surgery under oncologic criteria (complete resection).
- •Performance status (ECOG) 0 or
- •Patients with life expectancy greater than 6 months.
- •Patients with at least one accessible target lesion for gene inoculation (superficial localizations of the primary tumor, satelitosis, subcutaneous or accessible lymph node metastasis).
- •Patients with measurable disease (according to RECIST 1.1 criteria, irrespective of the target lesion chosen for suicide gene inoculation)
- •Patients with signed informed consent.
排除标准
- •Patients with uncontrolled cardiovascular disease
- •Patients with uncontrolled respiratory disease.
- •Patients with uncontrolled immune disease.
- •Patients with glucocorticoids or immunosuppressive drugs or agents with immunomodulatory activity (except non-steroidal anti-inflammatory agents) up to 2 weeks before treatment.
- •Patients performing other experimental therapies.
- •Patients who are pregnant or breastfeeding.
- •Patients undergoing concurrent chemotherapy or radiation therapy.
- •Uncontrolled diabetes.
- •Patients with active diagnosis of other malignant neoplasms.
- •HIV-positive patients.
- •Uncontrolled thyroid abnormality.
- •Patients with significant medical morbidity.
- •Patients with a history of allergic reactions to chemicals or similar to those used in this study.
- •Metastasis in the central nervous system.
- •Laboratory eligibility criteria excluded:
- •Hemoglobin: <8 g / dL, leukocytes: <3,000 / mm3, platelets: <100,000 / mm3, neutrophils: <1000 / mm3, hematocrit: <25%. bilirubin> 2.0 mg / dL, GOT or GPT: 2.5 times> than normal upper institutional limit (ULN), alkaline phosphatase: 2 times> ULN, creatinine> 2.0 mg / dL, creatinine clearence : <60 ml / min / 1.73 m2.
结局指标
主要结局
Safety reported as the number of treatment-related adverse events as assessed by CTCAE v4.03
时间窗: 1 year
Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf).
次要结局
未报告次要终点
研究者
Simonovich Ventura, MD
Medical Doctor
Hospital Italiano de Buenos Aires