Ceramide NanoLiposome in Patients With Advanced Solid Tumors

Conditions:Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:March 15, 2017
End Date:August 2019
Contact:Keystone Nano, Inc. Clinical Trials Information

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Phase I Study of C6 Ceramide NanoLiposome in Patients With Advanced Solid Tumors

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

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

- 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

- 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
We found this trial at
1300 Jefferson Park Avenue
Charlottesville, Virginia 22908
Phone: 434-924-9199
University of Virginia Cancer Center We are fortunate in having state of the art clinical...
Charlottesville, VA
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22 South Greene Street
Baltimore, Maryland 21201
Phone: 410-328-8611
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
Baltimore, MD
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Charleston, South Carolina 29425
Phone: 843-792-9007
Charleston, SC
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