A Pilot Trial of GI-4000 Plus Bevacizumab and Either FOLFOX or FOLFIRI in Patients With Ras Mutant Positive Metastatic Colorectal Cancer, Either Newly Diagnosed or Previously Treated.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Number of Participants Alive and Free of Progression at 4 Months (Patients Who Have Undergone Prior Therapy) and 10 Months (Untreated Patients)
研究概览
简要总结
The purpose of this study is to test the safety of GI-4000 and see what effects (good and bad) it has against cancer over time. This study is also being done to measure the immune response to GI-4000. Study drug will be given in addition to a standard of care which is a standard therapy given to patients with your type of cancer (colon).
详细描述
Subject visits will occur 1-4 weeks prior to initiation of GI-4000, then
- In newly diagnosed (Group A) patients, at every FOLFOX/FOLFIRI plus bevacizumab visit, bevacizumab and GI-4000 dosing visit, GI-4000 dosing visit and then quarterly after completion of therapy
- In patients with stable disease who have completed a first line therapy with an oxaliplatin or irinotecan plus fluoropyrimidine and bevacizumab containing regimen (Group B), at every bevacizumab and GI-4000 dosing visit, GI-4000 dosing visit and then quarterly after completion of therapy
Group A patients (N=26) will be enrolled into the study prior to the initiation of first line therapy with bevacizumab plus either FOLFOX (N=13) or FOLFIRI (N=13)
- Subjects will receive 1 40 yeast units (YU) dose of GI-4000 prior to initiation of FOLFOX or FOLFIRI plus bevacizumab, then intercycle doses of GI-4000 will be given 7 days after each cycle while first line therapy is given (up to 8 cycles)
- After completion of first line therapy, subjects will enter the maintenance phase in which bevacizumab and GI-4000 will be given concurrently every 2 weeks for as long as therapy can be tolerated or until progression
- If a subject discontinues bevacizumab therapy due to intolerance, the subject will continue GI-4000 every 2 weeks until progression, intolerance or withdrawal from the study
Group B patients (N=26) with stable disease who have completed a first line therapy with an oxaliplatin or irinotecan plus fluoropyrimidine and bevacizumab containing regimen ) will enter the trial prior to receiving therapy with bevacizumab
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Histologically or cytologically confirmed diagnosis of metastatic colorectal cancer with a Ras mutation
- •Measurable or evaluable disease
- •No prior therapy fore metastatic disease except for group A: > 6 months since completion of adjuvant therapy and Group B: those patients who enroll just after completing bevacizumab plus FOLFOX or FOLFIRI
- •Anticipated survival of at least 6 months
- •Ambulatory with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Ability to maintain weight
- •Normal organ and marrow function
- •Women of child-bearing potential and men must agree to avoid pregnancy or fathering a child for the duration of study participation and for 6 months after the final scheduled study visit.
- •Ability to understand and willingness to sign a written informed consent document
排除标准
- •Prior chemotherapy other than that listed in inclusion criteria
- •Receiving any other investigational agent
- •Known brain metastases, uncontrolled seizure disorders, encephalitis, or multiple sclerosis
- •History of known hypersensitivity to S. cerevisiae, bevacizumab or any component of FOLFOX or FOLFIRI
- •Concurrent and chronic therapy with corticosteroids or any other immunosuppressive drugs
- •Uncontrolled hypertension, unstable angina, congestive heart failure, peripheral vascular disease, serious cardiac arrythmias requiring medication
- •History of heart attack or stroke within 6 months before enrollment
- •History of intra-abdominal abscess, abdominal fistula, gastrointestinal perforation, or active peptic ulcer disease
- •Bleeding disorder or coagulopathy
- •Serious non-healing wound, ulcer or bone fracture
- •Major surgical procedure, open biopsy, or traumatic injury within 4 weeks prior to enrollment or anticipation of need for surgery during the study
- •Known active infection with HIV, hepatitis B or C
- •History of splenectomy
- •History of Crohn's disease or ulcerative colitis
- •History of organ transplantation
- •Evidence of immunodeficiency or immune suppression
- •Any Autoimmune disease
- •Active infection
- •Concurrent malignancy
- •Pregnant or nursing
研究组 & 干预措施
Chemotherapy and GI-4000
Standard chemotherapy and bevacizumab 40 yeast units (YU) GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.
maintenance of GI-4000 injection and bevacizumab every 2 weeks
干预措施: chemotherapy and GI-4000 (Drug)
GI-4000 and bevacizumab
maintenance with GI-4000 and bevacizumab for patients who have completed first-line chemotherapy
干预措施: GI-4000 (Drug)
结局指标
主要结局
Number of Participants Alive and Free of Progression at 4 Months (Patients Who Have Undergone Prior Therapy) and 10 Months (Untreated Patients)
时间窗: 4 Months for patients who had undergone prior 1st-line therapy, and 10 months for previously untreated patients
Clinical benefit rate is defined as the proportion of patients alive and free of progression at 4 Months (Patients Who Have Undergone Prior Therapy) and 10 Months (Untreated Patients), assessed from first treatment with GI-4000. Progression is defined as CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter of the target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of the target lesions; or SD (stable disease) = small changes that do not meet the above criteria.
次要结局
未报告次要终点