Clinical trial NCT02834611: Ceramide NanoLiposome in Patients With Advanced Solid Tumors
Official title: Phase I Study of C6 Ceramide NanoLiposome in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Carcinoma
Solid Tumors
Tumor
Lead sponsor: Keystone Nano, Inc
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2016-07-15
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a dose escalation study of Ceramide NanoLiposome in patients with advanced solid tumors.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum tolerated dose of Ceramide NanoLiposome in patients with advanced solid tumors.
timeFrame: 24 months
Secondary outcomes:
measure: Recommended phase II dose
timeFrame: 24 months
measure: Incidence of treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 24 months
measure: Peak plasma concentration (Cmax)
timeFrame: 24 months
measure: Time to maximum plasma concentration (Tmax)
timeFrame: 24 months
measure: Ceramide NanoLiposome half-life (t1/2)
timeFrame: 24 months
measure: Objective response rate per RECIST v1.1
timeFrame: 24 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Greenebaum Cancer Center
state: Maryland
city: Charleston
country: United States
facility: Medical University of South Carolina, Hollings Cancer Center
state: South Carolina
city: Charlottesville
country: United States
facility: University of Virginia Cancer Center
state: Virginia
Study officials:
affiliation: University of Maryland Greenebaum Cancer Center
name: Edward Sausville, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: