NCT07649070尚未招募2 期
Phase 2 Trial of G207 + 5 Gy Radiation for Children With High-Grade Gliomas
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Safety and Adverse Events (AEs)
研究概览
简要总结
The goal of this clinical research study is to learn about the safety and effects of G207 combined with radiation therapy in patients with recurrent or progressive high-grade glioma (HGG).
详细描述
Primary Objective:
To assess the efficacy of G207 administered intratumorally followed by 5 Gy radiation within 24hours in patients with recurrent or progressive high-grade glioma (HGG) as measured by postprogression overall survival (pp-OS), focused on patients with one progression following their priorsurgery and radiotherapy, compared to matched historical controls.
Secondary Objectives:
To describe the pp-OS survival in patients treated with G207 + 5 Gy with more than one progression following their prior surgery and radiotherapy
To establish safety and characterize toxicity of G207 + 5 Gy radiation
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
- 3 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Pregnant women are excluded from this study. Female patients of childbearing potential must have a negative serum or urine pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- •Pregnant women are excluded from this study because G207 is an agent with the potential for teratogenic or abortifacient effects.
- •Lactation Status
- •Lactating females are not eligible unless they have agreed not to breastfeed their infants
- •Because there is an unknown potential risk for adverse events in nursing infants secondary to treatment of the mother with G207, breastfeeding should be discontinued if the mother is treated with G
- •Disease-Related Exclusion Criteria
- •Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen for this trial.
- •Patients with primary tumor involving the cerebellum, brainstem or spinal cord, or that would require surgical access through a ventricle to deliver the prescribed protocol treatment.
- •Metastatic disease or diffuse, widespread, abnormal tumor pattern involving 3 or more lobes of the brain.
- •Tumor with evidence of clinically significant uncal herniation or midline shift, or evidence of ventricular obstruction from tumor or tonsillar herniation.
- •Concurrent Illness
- •Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the patient's ability to undergo surgery and/or tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results.
- •Known HIV seropositivity.
- •Diagnosis of encephalitis or CNS infection < 12 weeks prior, or receiving ongoing treatment for encephalitis, CNS infection or multiple sclerosis.
- •Concurrent Medications
- •Patients who are receiving any other anti-cancer or investigational drug therapy are ineligible.
- •Patients who are receiving ≥ 2 mg of dexamethasone (or ≥ 10 mg of prednisone) daily
- •Patient requires an escalation in ongoing systemic corticosteroid therapy within 7 days prior to G207 inoculation
- •For this study, 'systemic corticosteroids' include oral, intravenous, or intramuscular formulations. A single, non-consecutive dose does not constitute exclusion. Physiologic corticosteroid replacement therapy (e.g., hydrocortisone for adrenal insufficiency), intermittent use of bronchodilators and topical steroids, is not considered immunosuppressive and does not constitute exclusion.
- •Concurrent therapy with any drug active against HSV (acyclovir, valacyclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir).
- •Inability to Participate
- •Patients who in the opinion of the investigator are unwilling or unable to return for required followup visits or obtain follow-up studies required to assess toxicity to therapy or to adhere to the drug administration plan, other study procedures, and study restrictions.
研究组 & 干预措施
Treatment with G207 (IT) + 5 Gy Radiation
Experimental
Treatment will be administered on a inpatient basis.
干预措施: G207 (Drug)
结局指标
主要结局
Safety and Adverse Events (AEs)
时间窗: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点
研究者
研究点 (1)
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