Ceramide NanoLiposome in Patients With Advanced Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-15

Study Completion Date

2023-11-01

Brief Summary

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

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Detailed Description

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Conditions

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Cancer Carcinoma Solid Tumors Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ceramide NanoLiposome

Dose escalation of Ceramide NanoLiposome

Group Type EXPERIMENTAL

Ceramide NanoLiposome

Intervention Type DRUG

Intravenous administration of Ceramide NanoLiposome

Interventions

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Ceramide NanoLiposome

Intravenous administration of Ceramide NanoLiposome

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No