Ceramide NanoLiposome in Patients With Advanced Solid Tumors

Keystone Nano

Status and phase

Completed

Phase 1

Conditions

Carcinoma

Tumor

Cancer

Solid Tumors

Treatments

Drug: Ceramide NanoLiposome

Study type

Interventional

Funder types

Industry

NIH

Identifiers

R44CA195793 (U.S. NIH Grant/Contract)

KNAN1001

Details and patient eligibility

About

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

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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