A Phase I Trial of the Immunostimulant JVRS-100 for the Treatment of Patients With Relapsed or Refractory Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Tolerability of JVRS-100
研究概览
简要总结
This is a Phase 1, open-label, dose escalation study of JVRS-100. The study will proceed in 2 stages to minimize the number of patients treated at doses substantially below the recommended phase 2 dose. In stage 1, an accelerated titration schema will be followed with one patient at each dose level. Stage 2 will commence after a dose limiting toxicity is observed in stage 1 or after the maximum dose for stage 1 is reached. Stage 2 will follow a modified Fibonacci schema with 3-6 subjects at each dose level until a recommended phase 2 dose is determined. The cohort will then be expanded to a maximum of 12 patients to more fully evaluate the recommended phase 2 dose.
详细描述
This is a Phase 1, open-label, dose escalation study of JVRS-100. The study will proceed in 2 stages to minimize the number of patients treated at doses substantially below the recommended phase 2 dose. In stage 1, cohorts of three will be treated at each dose level however doses will be doubled from level to level. Stage 2 will commence after a dose limiting toxicity is observed in stage 1 or after the maximum dose for stage 1 is reached. Stage 2 will follow a modified Fibonacci schema with 3-6 subjects at each dose level until a recommended phase 2 dose is determined. The cohort will then be expanded to a maximum of 12 patients to more fully evaluate the recommended phase 2 dose. The Principal Investigator will assign dose level to be administered to all patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- •18 years of age
- •Histologically or cytologically documented relapsed or refractory acute leukemia
- •Unlikely to benefit from standard therapy in the opinion of the investigator or refuse standard therapy
- •ECOG performance status 0-2
- •Adequate renal and hepatic function
- •No hematologic criteria for WBC, Hbg or platelets
- •Negative virology screen for HIV, hepatitis B surface antigen & hepatitis C
- •Female patients of childbearing potential must have a negative serum pregnancy test
- •Male & female patients must agree to use a medically acceptable barrier and/or chemical contraceptive method during the study and for a minimum of 3 months afte the last dose of study treatment.
- •Patients post blood or marrow transplant should demonstrate a circulating CD8 count of at lest 200 cells/ul
排除标准
- •Active CNS leukemia
- •Current concomitant chemotherapy, radiation therapy or immunotherapy
- •Receipt of any investigational agent within 28 days of first dose of JVRS-100
- •Persistent clinically significant toxicity from prior anticancer therapy that is > Grade 2 (NCI CTCAE v3.0)
- •Bone marrow or stem cell transplant within 3 months prior to first dose of JVRS-100
- •Chronic administration of immunosuppressive agents within 14 days of first dose of JVRS-
- •Use of inhaled steroids, nasal sprays, eye drops, and topical creams for small body areas is allowed.
- •Pregnant or lactating
- •History of prior malignancy other than leukemia within the past 5 years, excluding basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- •Patients with a systemic fungal, bacterial, viral, or other infection not controlled
- •Any condition which, in the opinion of the investigator, would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
研究组 & 干预措施
Phase I
Three patients will be enrolled at dose Level 1. If the patient does not completed the three infusion of JVRS-100 during cycle 1 for reason other than toxicity, another patient will be accrued at the same dose level.
干预措施: JVRS-100 (Drug)
Phase II
3 patients will be enrolled at a given dose level. If one of these patients experiences a dose limiting toxicity, an additional 3 patients will be enrolled at the given dose level. If the 1st 2 subjects enrolled and treated at a given dose experience dose limiting toxicities, no additional subjects will be enrolled at that dose. Dose escalation may proceed if < 2/6 patients at a given dose level experience a LDT. If ≥ 2/6 patients experience a DLT at a given dose level, the next lower dose level will be considered the RP2D. If a patient does not complete the 3 infusions of JVRS-100 during Cycle 1 for reasons other than toxicity, another patient will be accrued at the same dose level. Once the RP2D is established, the cohort will be expanded to a total of 12 patients.
干预措施: JVRS-100 (Drug)
结局指标
主要结局
Tolerability of JVRS-100
时间窗: Day 30 of cycle #1
Toxicities will be assessed on day 30 of cycle 1. Establish dose limiting toxicity and a maximum tolerated dose recommended Phase 2 dose.
次要结局
- Define parameters of immune activation after JVRS-100 therapy.(Day 30 of cycle #1)
研究者
David F. Claxton, MD
Professor of Medicine
Milton S. Hershey Medical Center