Interleukin-2 Imaging as a Guide to Cancer Immunotherapy (Ipilimumab or Pembrolizumab) in Advanced Melanoma: A Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Proportion of patients who develop scintigraphy limiting toxicities (SLTs)
研究概览
简要总结
This pilot clinical trial studies aldesleukin imaging in viewing tumor growth in patients with stage IV melanoma receiving ipilimumab or pembrolizumab therapy. Diagnostic procedures, such as single-photon emission computed tomography (SPECT), uses radioactive drugs and a scanner to make detailed pictures of areas inside the body and may be a less invasive way to check for stage IV melanoma. Radioactive drugs, such as technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2, carry radiation directly to cancer cells and may be able to differentiate between tumor growth due to inflammation versus tumor progression in patients with stage IV melanoma receiving therapy.
详细描述
PRIMARY OBJECTIVES:
I. Feasibility/biodistribution of 99mTc-HYNIC-IL2 (technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin 2) scintigraphy in patients with metastatic melanoma undergoing immunotherapy with either ipilimumab (commercial source) or pembrolizumab.
SECONDARY OBJECTIVES:
I. Correlation of tumor infiltrating lymphocyte (TIL) invasion (scintigraphy/histology) with tumor burden; and description of any clinical side effects associated with imaging.
TERTIARY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Pathologic proof of stage IV melanoma (pathology report confirmation) with plans to initiate therapy with ipilimumab or pembrolizumab according to Food and Drug Administration (FDA) approved guidelines, with multiple lesions such that
- •Two of these lesions are in the same organ and at least one of these two lesions is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 using either intravenous (IV) contrast enhanced computed tomography (CT) or CT component of positron emission tomography (PET)/CT OR
- •Three of these lesions are in different organs and at least one of these 3 lesions is measurable by RECIST 1.1 using either IV contrast enhanced CT or CT component of PET/CT
- •Patient eligible for and will be receiving ipilimumab or pembrolizumab as standard of care therapy
- •Absolute neutrophil count (ANC) >= 1500 mL
- •Hemoglobin (Hgb) > 10 g/dL
- •Platelets (PLT) >= 50,000 mL
- •Aspartate aminotransferase (AST) =< 3 x upper limit of normal (ULN)
- •Alkaline phosphatase =< 3 x ULN; up to 5 x allowed for patients with liver metastases
- •Ability to provide informed consent
- •Willingness to return to Mayo Clinic Rochester for follow-up
- •Life expectancy >= 12 weeks
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
- •For women of childbearing potential, a negative serum pregnancy test =< 7 days prior to registration
- •Willingness to participate in mandatory imaging studies as well as provide mandatory blood samples for correlative research
- •Tumor accessible for biopsy
排除标准
- •Uncontrolled or current infection
- •Known allergy to 99mTc-HYNIC-IL2 or components
- •Any of the following prior therapies with interval since most recent treatment:
- •Chemotherapy =< 3 weeks prior to registration
- •Biologic therapy =< 3 weeks prior to registration
- •Radiation therapy =< 3 weeks prior to registration
- •Failure to recover from side effects of prior chemotherapy or surgery
- •Any of the following:
- •Pregnant women
- •Nursing women
- •Women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.)
研究组 & 干预措施
Cohort I (scintigraphy prior to immunotherapy and 12 weeks)
Patients undergo technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2 scintigraphy prior to receiving ipilimumab or pembrolizumab and at 12 weeks.
干预措施: Laboratory Biomarker Analysis (Other)
Cohort I (scintigraphy prior to immunotherapy and 12 weeks)
Patients undergo technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2 scintigraphy prior to receiving ipilimumab or pembrolizumab and at 12 weeks.
干预措施: Radionuclide Imaging (Procedure)
Cohort I (scintigraphy prior to immunotherapy and 12 weeks)
Patients undergo technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2 scintigraphy prior to receiving ipilimumab or pembrolizumab and at 12 weeks.
干预措施: Technetium Tc 99 Hydrazinonicotinamide-Tricine-linked Interleukin-2 (Biological)
Cohort II (scintograpy prior to immunotherapy, 3-4, 12 weeks)
Patients undergo technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2 scintigraphy prior to receiving ipilimumab or pembrolizumab, at 3-4 weeks, and at 12 weeks.
干预措施: Laboratory Biomarker Analysis (Other)
Cohort II (scintograpy prior to immunotherapy, 3-4, 12 weeks)
Patients undergo technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2 scintigraphy prior to receiving ipilimumab or pembrolizumab, at 3-4 weeks, and at 12 weeks.
干预措施: Radionuclide Imaging (Procedure)
Cohort II (scintograpy prior to immunotherapy, 3-4, 12 weeks)
Patients undergo technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2 scintigraphy prior to receiving ipilimumab or pembrolizumab, at 3-4 weeks, and at 12 weeks.
干预措施: Technetium Tc 99 Hydrazinonicotinamide-Tricine-linked Interleukin-2 (Biological)
结局指标
主要结局
Proportion of patients who develop scintigraphy limiting toxicities (SLTs)
时间窗: Up to 12 weeks
SLTs include grade 2+ allergic reaction, grade 3+ anaphylaxis, grade 2+ injection site reaction, or grade 3+ non-hematologic toxicity (not attributed to immunotherapy treatment/progression or a co-morbid condition). A 95% binomial confidence interval of the proportion of patients who develop a grade 2+ allergic reaction, grade 3+ anaphylaxis, or grade 2+ injection site reaction will be constructed.
次要结局
- Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0(Up to 30-45 days after study discontinuation)
- Target-to-background (T/B) ratio as determined by technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2 scintigraphy(Up to 12 weeks)
- TIL invasion as determined by technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2 scintigraphy(Up to 12 weeks)