Randomized, Comparative Phase II/III Study Between Treatment With CSF470 Vaccine (Allogeneic, Irradiated) Plus BCG and MOLGRAMOSTIN (rhGM-CSF) as Adjuvants and Interferon-alfa 2b (IFN-ALPHA), in Stages IIB, IIC and III Post Surgery Cutaneous Melanoma Patients
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Efficacy
研究概览
简要总结
Randomized, open, Phase II-III study, comparative between treatment with CSF-470 vaccine , allogeneic, irradiated with BCG and molgramostin (rHuGM-CSF) as adjuvants and interferon alfa 2b (IFN-alpha2b) treatment , in stages IIB, IIC o III (AJCC) post-surgery cutaneous melanoma patients. This study has been approved by ANMAT ( Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT)), number 1556/2011 (www.anmat.gov.ar).
The study Institution is Instituto Médico Especializado Alexander Fleming, Ciudad Autónoma de Buenos Aires, Argentina. The Sponsor is Laboratory Pablo Cassará (LPC, S.R.L.).
Study population include a total of 108 patients (72 patients will receive CSF470 vaccine and 36 patients will receive alpha IFN-alpha 2b) for a total of 24 months.
CSF-470 treatment will consist of four vaccine doses id injection (three weeks apart), then one dose every two months for the first year and them every three months for the second year.
Each vaccine consist of a mixture of 17,6.106 melanoma cells, from four melanoma cell lines, not genetically modified and lethally irradiated. As adjuvant BCG (120 µg prot) the first day and rHuGM-CSF (Molgramostim, 400 µg, fractionated in four days doses) will be used.
IFN-alpha 2b treatment will consist of s.c. injection of 10 million units (MU) (5 t/w ) for four weeks and then 5 MU (3t/w) for 23 months.
Both treatments will also compare quality of life (QOL) and study a possible correlation in the CSF470 vaccine arm between the induced immune response and clinical outcome
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed cutaneous melanoma stages IIB, IIC or III (AJCC)
- •patients non-detectable disease (NED) after surgery as asserted by CAT scans. Melanoma pts with unknown primary tumor site could be included in the study
- •life expectancy > 6 months
- •performance status (ECOG) 0 or 1
- •Time post surgery not more than 4 months
- •no chemotherapy, radiotherapy or any biological treatments prior to this study.
- •patients must have CATscans of brain, thorax, abdomen and pelvis in the 60 previous days to trial enrolling
- •To have laboratory studies (no more than 15 days before entering the study)
- •laboratory eligibility criteria include: hematocrit: ≥35 (hemoglobin > 10,5 gr %); WBC count > 3500/mm3, platelets > 100.000/mm3, total and direct bilirubin, serum oxalacetic transaminase and glutamic pyruvic transaminase < 1.5 fold the upper normal value; LDH ≤ 450 mU/ml
- •negative serology for HIV, anti-HCV and HBsAg
- •serum creatinine < 2.0 mg %
- •all patients must give written informed consent before inclusion in the Study.
排除标准
- •Pregnant or breast-feeding women
- •Diabetes (Type I or II)
- •Antecedents of psychiatric diseases
- •Evidence of active infections
- •Antecedents of viral or autoimmune hepatitis
- •Previous autoimmune diseases
- •Morbid Obesity, defined as CMI (Corporal mass index)>37 kg/m2 in women and >40 kg/m2 in men.
- •Other diseases that require treatment with regular corticoids or non steroids anti-inflammatory drugs
研究组 & 干预措施
Interferon alpha 2 b
Interferon alpha 2b treatment will consist of s.c. injection of 10 MU (5 t/w) for four weeks and then 5 MU (3t/w) for 23 months.
干预措施: interferon alpha 2b (Drug)
CSF470 vaccine, BCG, Molgramostim
CSF470 vaccine, BCG, Molgramostim
CSF-470 treatment will consist of four vaccine doses id injection (three weeks apart), then one dose every two months for the first year and them every three months for the second year.
Each vaccine consist of a mixture of 17,6.106 melanoma cells , from four melanoma cell lines, not genetically modified and lethally irradiated. As adjuvant BCG (120 µg prot) the first day and rhGM-CSF (Molgramostim 400 µg, fractionated in four days doses) will be used.
干预措施: CSF470 vaccine, BCG, Molgramostim (Biological)
结局指标
主要结局
Efficacy
时间窗: two years
OS, DFS, Partial or total remission (PR or CR)
security
时间窗: two years
measured according to the NCI-Common Toxicity Criteria
次要结局
- Quality of Life(two years)
- Induction of immune responses(two years)
研究者
José Mordoh
MD, PhD
Laboratorio Pablo Cassará S.R.L.