Ceramide NanoLiposome in Patients With Advanced Solid Tumors
Trial Status: Active
This study is a dose escalation study of Ceramide NanoLiposome in patients with advanced solid tumors.
- Signed informed consent/authorization is obtained prior to conducting any study-specific screening procedures.
- 18 years of age or order
- Histologic or cytologic diagnosis of cancer
- Patients without a curative therapy or whose tumor does not have standard chemotherapy
- At least 4 weeks after the last dose of chemotherapy or radiation therapy; 6 weeks for mitoxantrone or mitomycin therapy
- Eastern Cooperative Oncology Group (ECOG) performance status must be ≤2 (Appendix A).
- Adequate hepatic, renal, and bone marrow function:
- Absolute neutrophil count ≥ 1,000/microliter (uL)
- Platelets ≥ 100,000/uL
- Total bilirubin ≤2.0
- AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional ULN
- Creatinine ≤1.2 mg/dL or clearance ≥50ml/min (Cockcroft-Gault)
- All participants (male and female) with reproductive potential must practice an effective method of contraception while on this study in order to minimize risks to fetuses.
- Radiographic evidence of measurable disease tumor lesion (≥ 1cm in greatest dimension) or nodal disease (>1.5cm in greatest dimension)
- Men and women of all ethnic groups are eligible for this trial.
- Females at reproductive age must have a negative urine pregnancy test prior to entry to this study
- Life expectancy is greater than 12 weeks.
- Patients with controlled CNS disease and off steroids are eligible.
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias not well controlled with medication, myocardial infarction within the previous 6 months, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients may not be receiving any other concurrent investigational agents, or have received any investigational agent within four weeks of commencing this protocol.
- Since the teratogenic potential of this combination is currently unknown, females who are pregnant or lactating are excluded. Males and females should perform abstinence or use barrier to prevent pregnancy.
- History of any other malignancies in the last 2 years except in-situ cancer, non-muscle invasive bladder cancer, basal or squamous cell skin cancer are eligible
- Patients known to be HIV(+), Hep BsAg(+), or Hep C(+) are excluded as the effect of the agent on immune system has not been assessed
- Patients with history of hypersensitivity to liposomal products
- Patients with primary CNS malignancies or leptomeningeal disease are excluded
University of Maryland / Greenebaum Cancer Center
Medical University of South Carolina
University of Virginia Cancer Center
Trial Phase Phase I
Trial Type Treatment
Keystone Nano, Inc
- Primary ID KNAN1001
- Secondary IDs NCI-2016-02016, R44CA195793
- Clinicaltrials.gov ID NCT02834611