Purpose

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

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
Phase 1
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Ceramide NanoLiposome
Dose escalation of Ceramide NanoLiposome
  • Drug: Ceramide NanoLiposome
    Intravenous administration of Ceramide NanoLiposome

Recruiting Locations

University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland 21201
Contact:
Joann Alimurong
joann.alimurong@umm.edu

More Details

NCT ID
NCT02834611
Status
Recruiting
Sponsor
Keystone Nano, Inc

Study Contact

Keystone Nano, Inc. Clinical Trials Information
8144665080
clinicaltrials@keystonenano.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.