Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Recurrence

Breast Neoplasms

Breast Diseases

Skin Diseases

Topical ceramide cream is applied to all cutaneous lesions twice daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then at 1 and 3 months. Patients are followed every 3 months for 1 year and then every 6 months for 4 years.

ceramide

Aminah Jatoi, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of ceramide cream in treating women who have cutaneous breast cancer.

OBJECTIVES: I. Determine the objective response rate in women with cutaneous breast cancer treated with topical ceramide cream. II. Determine the time to progression in patients treated with this regimen. III. Determine the toxicity of this regimen in these patients. IV. Assess the quality of life of these patients treated with this regimen.

OUTLINE: Topical ceramide cream is applied to all cutaneous lesions twice daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then at 1 and 3 months. Patients are followed every 3 months for 1 year and then every 6 months for 4 years.

Ceramide Cream in Treating Women With Cutaneous Breast Cancer

A Phase II Study Of Topical Ceramide Lipids As Treatment For Cutaneous Breast Cancer

National Cancer Institute (NCI)

Alliance for Clinical Trials in Oncology

Blood and Lymph Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Ceramide NanoLiposome will be administered by Intravenous Dosing twice per week in accordance with the protocol relative to dose escalation. There is no placebo group or arm of the study.

Ceramide NanoLiposome will be given by IV twice a week. The dose, which is based on body size, will be increased for the next group of patients if the first group of patients tolerates that dose and it will decrease for the next group if they do not tolerate the dose.

Ceramide NanoLiposome (Ceraxa)

James H Adair, Ph.D.

Bernadette M Adair, BS

Wanda Neidig

Racheal Griffith, RN

David Claxton, MD

Cory Caldwell

Jungeun Kim

Michael Keng, MD

Daniel Vlock, MD

Christopher Prior, Ph.D.

The study explores whether Ceramide NanoLiposome (CNL) combined with other conventional cancer-fighting drugs makes them work better.

The research team has shown that C6 ceramide nanoliposome (CNL) has anti-cancer activity in laboratory models of AML and that when it is combined with other cancer-fighting drugs, it works better.

The primary goal of this study is to evaluate the safety of CNL given without other cancer treatments in patients with AML where either their initial treatment didn't work or it stopped working and your AML came back (refractory or relapsed AML, or RR-AML). This study seeks to determine the right dose to start with in later studies when CNL is combined with other drugs.

CNL is given by intravenous (IV) infusion and will be given twice a week in this study. Participants will receive study treatment as long as it is considered safe for them to continue, though their disease status will be checked regularly to make sure that their disease has not gotten worse. Blood samples will be collected at many time-points in order to see how their bodies are responding to the drug and how long it stays in the blood.

The first patients in the study will start at one dose of the drug and, if that is shown to be safe, the next group will be treated at a slightly higher dose. Participants will be given CNL by intravenous (IV) infusion twice a week over about 2 hours and then they will be monitored for about 2 hours to make sure they don't have any bad side effects, but initially patients will be required to stay at the site for about 6 hours after the start of the infusion in order to get blood draws to see how long the drug stays active in their system.

Participants will have a bone marrow biopsy before their second "cycle" of drug (after about 1 month) and then again before their third cycle of drug in order to see how their disease is responding. After that, bone marrow biopsies will be about every other cycle based on what the study doctor recommends. If the doctor doesn't think that CNL is helping their disease, of if their doctor decides that it is not safe for them to continue, they will be taken off study treatment. Participants will be followed for safety and disease status for up to 6 months.

Study of C6 Ceramide NanoLiposome (CNL) in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Phase I Study of C6 Ceramide NanoLiposome (CNL) in Patients With Relapsed/Refractory Acute Myeloid Leukemia (RR-AML)

Dose Limiting Toxicities within the first cycle of CNL monotherapy. See section 13.5 of Protocol for the complete list of Dose Limiting Toxicities

Severity of Adverse Event As Described in Protocol

Duration of Adverse Events, As Described in Protocol, measured in days

Duration of therapy provided as measured in days

Dose levels administered in milligrams per m2

Maximum Serum Concentration measured, in nanograms/milliliter

Time to maximum concentration measured, in minutes

Time for drug to be reduced to half of the starting concentration (in minutes)

The Amount of Study Drug Cleared per unit time (Nanograms/Minute)

Ratio of Ceramide 16 to Ceramide 24 (ng of C16/ng of C18) from bone marrow biopsy

Complete Response with Incomplete Hematological Recovery as defined by blasts in bone marrow

Partial Remission (as defined by blasts in bone marrow)

Grade 3 and 4 adverse events as defined by CTCAE v5.0

Overall response of CNL monotherapy in patients with RR-AML: Complete remission (CR) + Complete remission with incomplete count recovery (CRi) + partial response (PR). CR, CRi and PR as defined as European LeukemiaNet 2017 (ELN 2017) response criteria

Event-free survival (EFS): the time from registration until documented refractory disease, relapse after achieving CR/CRi, or death from any cause, whichever is observed first

Quality of life according to EORTC Quality of Life Questionnaire C30

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ceramide Cream in Treating Women With Cutaneous Breast Cancer	NCT00008320	Breast Cancer	ceramide	18 Years -	Alliance for Clinical Trials in Oncology
Ceramide Cream in Treating Women With Cutaneous Breast Cancer	NCT00008320	Breast Cancer	ceramide	18 Years -	Alliance for Clinical Trials in Oncology
Study of C6 Ceramide NanoLiposome (CNL) in Patients With Relapsed/Refractory Acute Myeloid Leukemia	NCT04716452	Acute Myeloid L... Acute Myeloid L...	Ceramide NanoLi...	18 Years -	Keystone Nano, Inc

Spots Global Cancer Trial Database for ceramide

Every month we try and update this database with for ceramide cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ceramide

Every month we try and update this database with for ceramide cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ceramide cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.