Ceramide NanoLiposome in Patients With Advanced Solid Tumors
Purpose
This study is a dose escalation study of Ceramide NanoLiposome in patients with advanced solid tumors.
Conditions
- Cancer
- Carcinoma
- Solid Tumors
- Tumor
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
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Ceramide NanoLiposome |
Dose escalation of Ceramide NanoLiposome |
|
Recruiting Locations
University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland 21201
Baltimore, Maryland 21201
More Details
- Status
- Unknown status
- Sponsor
- Keystone Nano, Inc
Study Contact
Keystone Nano, Inc. Clinical Trials Information8144665080
clinicaltrials@keystonenano.com