Ceramide NanoLiposome in Patients With Advanced Solid Tumors

Status: Active

Description

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

Locations & Contacts

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: Active
Name Not Available

South Carolina

Charleston
Medical University of South Carolina
Status: Temporarily closed to accrual
Name Not Available

Virginia

Charlottesville
University of Virginia Cancer Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Keystone Nano, Inc

Trial IDs

Primary ID KNAN1001
Secondary IDs NCI-2016-02016, R44CA195793
Clinicaltrials.gov ID NCT02834611