Ceramide NanoLiposome in Patients With Advanced Solid Tumors

• Status: Unknown status
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Keystone Nano, Inc
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)

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