Cancer, Carcinoma, Solid Tumors, Tumor
Conditions
Brief summary
This study is a dose escalation study of Ceramide NanoLiposome in patients with advanced solid tumors.
Interventions
DRUGCeramide NanoLiposome
Intravenous administration of Ceramide NanoLiposome
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Keystone Nano, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose of Ceramide NanoLiposome in patients with advanced solid tumors. | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate per RECIST v1.1 | 24 months |
| Recommended phase II dose | 24 months |
| Ceramide NanoLiposome half-life (t1/2) | 24 months |
| Peak plasma concentration (Cmax) | 24 months |
| Time to maximum plasma concentration (Tmax) | 24 months |
| Incidence of treatment-related adverse events as assessed by CTCAE v4.0 | 24 months |
Countries
United States
Outcome results
None listed