Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Chlorotrianisene

Deferoxamine

Estrogens

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Iron

Chelating Agents

Iron Chelating Agents

Patients are treated with deferoxamine and conventional TACE.

Patients are treated with conventional TACE.

Conventional chemoembolization drugs are injected through hepatic artery.

Conventional TACE

Deferoxamine is injected before conventional transarterial chemoembolization.

Deferoxamine and conventional TACE

Min Li, M.D.

To investigate the safety and efficacy of deferoxamine (DFO) combined with conventional transarterial chemoembolization (TACE) in patients with unresectable hepatocellular carcinoma (HCC).

DFO, an iron chelator, is considered as a potential drug to the treatment of HCC. Ferrum is an important transition metal for organisms and the liver plays a major role in its storage. However, in pathologic conditions, it will lead to hepatocyte injury through the free radicals generated by excess iron. In addition, excess iron accumulation in the liver increases toxic free iron, which is closely associated with hepatic inflammation, as well as the development and progression of HCC. Reduction of iron is likely an important therapeutic targets for treating HCC. Iron reduction therapy has been efficacious in both in animal HCC models and results of clinical studies also suggest potential efficacy for HCC. DFO chelates iron by forming a stable complex that prevents the iron from entering into further chemical reactions. The investigators assume that DFO, combined with TACE, may provide additional efficacy in patients with unresectable HCC.

The Safety and Efficacy of Deferoxamine for Treating Unresectable Hepatocellular Carcinoma

The Safety and Efficacy of Deferoxamine Combined With Conventional Transarterial Chemoembolization in Patients With Unresectable Hepatocellular Carcinoma

PFS is defined as the time from the first day of therapy to the first evidence of disease progression or death from any cause. As classified according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, disease progression is having at least a 20% increase in the sum of the longest diameter of target lesions and/or unequivocal progression of a non-target lesion and/or detection of a new lesion. Participants who are alive and without disease progression and participants who did not progress and are subsequently lost to follow-up are censored at the last objective tumor assessment.

The time from first day of therapy to the first date of objective evidence of progressive disease (PD) by Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is defined as having at least a 20% increase in sum of longest diameter of target lesions and/or unequivocal progression of a non-target lesion and/or detection of new lesion. Time to PD is censored at the date of death or study discontinuation.

Overall survival (OS) is the duration from first dose to death due to any cause. OS is censored at last contact date for participants who are alive at the end of follow-up period or lost to follow-up.

Objective response rate (ORR) is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR). As classified according to Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria, CR is the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm) and normalization of tumor marker level of non-target lesions. PR is having at least a 30% decrease in sum of longest diameter of target lesions.

Duration of response is the interval from the date of initial documented response \[complete response (CR) , partial response (PR) or Stable disease\] to the first documented date of disease progression, initiation of other (or additional) antitumor therapy is first reported, or death due to any cause. As classified according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, CR is the disappearance of all target lesions, PR is having at least a 30% decrease in the sum of the longest diameter of target lesions, and stable disease is defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. Disease progression is having at least a 20% increase in the sum of the longest diameter of target lesions and/or unequivocal progression of a non-target lesion and/or detection of a new lesion. Data are censored for participants who did not progress or die.

Tumor necrosis is quantified in liver lesions greater than 2 cm at Baseline. When MRI showed many cut surfaces for a single tumor, tumor size and the size of necrotic area is measured by accumulation of the serial sections containing the tumor. Lipiodol accumulation without contrast enhance in tumor after TACE is regarded as an indication of necrosis. Tumor necrosis is assessed at Baseline and 1-3 days prior to the next scheduled transarterial chemoembolisation (TACE) till disease progression. The extent of tumor necrosis is presented as the percentage of the tumor volume at Baseline.

The iron of liver will be measured by MRI, where R2\* and QSM is applied to present the quantity of iron. Iron reduction is assessed at Baseline and 1-3 days prior to the next scheduled transarterial chemoembolisation. The test will be repeated 1 -3 days after the therapy. The reduction of liver iron will be calculated accordingly.

The iron of liver will be measured by MRI, where R2\* and QSM is applied to present the quantity of iron. All patients will undergo MRI before TACE, and the test will be repeated 1 -3 days after the therapy till disease progression. The reduction of liver iron will be calculated accordingly. Based on the measurements mentioned above, the prognostic value of reduction of liver iron will be analyzed.

Data presented are the number of participants who experienced treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), Grade 3 or higher TEAEs, or adverse events (AEs) leading to discontinuation of treatment that are considered by the investigator to be related to ramucirumab. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.

Jinan Military General Hospital

Director

Symptoms and General Pathology

Blood and Lymph Conditions

Immune System Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Iron Overload

Lymphoma

Hematologic Diseases

Bone Marrow Diseases

Precancerous Conditions

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Metabolic Diseases

Iron Metabolism Disorders

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Lymphosarcoma

Deferoxamine for \>=2 weeks prior to stem cells

Given intravenously or subcutaneously over 8-12 hours daily for at least three weeks prior to transplantation date and continue until the day before the participant receives their donor's stem cells.

deferoxamine

Philippe Armand, MD, PhD

The objective of this research study is to determine the safety and feasibility of chelation therapy with deferoxamine for patients with iron overload who are receiving a stem cell transplant. Patients who have iron overload prior to stem cell transplantation may have more toxicity from the transplantation procedure, and thus may benefit from an attempt at iron chelation pre- and peri-transplantation. In this study we are examining the use of deferoxamine starting 2 weeks to 3 months prior to transplantation and continuing through the preparative regimen.

Deferoxamine for Iron Overload Before Allogeneic Stem Cell Transplantation

A Pilot Study of Deferoxamine Before and During Myeloablative Allogeneic Stem Cell Transplantation for Patients With Myelodysplastic Syndromes or Acute Leukemia and Iron Overload

All patients meeting the criteria for Severe iron overload as defined by BOTH:

ferritin ≥ 1000 ng/ml and liver iron content(LIC) ≥ 5 mg/gdw were enrolled and received chelation therapy with Deferoxamine. All patients who received chelation therapy were monitored for grade 3 or above toxicity Attributable to Deferoxamine(grades defined by the CTCAE Version 3). The number of participants with grade 3 or higher toxicities were measured and used to determine the safety of chelation therapy.

Survival information for the 5 patients who were treated with deferoxamine was collected. This information was used to determine transplant-related mortality, relapse, disease-free and overall survival.

Brigham and Women's Hospital

Dana-Farber Cancer Institute

Principal Investigator

All patients received a maximum dose of 50mg/kg/d of deferoxamine as chelation therapy for at least 2 weeks prior to receiving myeloablative transplant.

All Patients

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

The number of patients enrolled on this study is far too small to draw reliable conclusions.

Baseline

6 month

1 year

Patients who met criteria for iron overload pre-transplant, as defined by the protocol, were enrolled on study for chelation therapy. Those patients who received therapy were monitored for toxicities using the CTCAE version 3.0.

Safety of Deferoxamine Therapy Determined by the Number of Participants With Grade 3 or Higher Toxicities.

Patients who received Deferoxamine and passed away as a result of transplant or study treatment without prior relapse at 1 year.

Transplant-Related Mortality (Deferoxamine)

Patients who received Deferoxamine and relapsed post transplant at 1 year.

Relapse (Deferoxamine)

Patients who received Deferoxamine and are currently alive without incidence of relapse at 1 year.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Safety and Efficacy of Deferoxamine for Treating Unresectable Hepatocellular Carcinoma	NCT03652467	Hepatocellular ...	Conventional TA... Deferoxamine an...	18 Years -	Jinan Military General Hospital
Deferoxamine for Iron Overload Before Allogeneic Stem Cell Transplantation	NCT00658411	Acute Myeloid L... Acute Lymphobla... Myelodysplastic...	deferoxamine	18 Years -	Dana-Farber Cancer Institute
Deferoxamine for Iron Overload Before Allogeneic Stem Cell Transplantation	NCT00658411	Acute Myeloid L... Acute Lymphobla... Myelodysplastic...	deferoxamine	18 Years -	Dana-Farber Cancer Institute
The Safety and Efficacy of Deferoxamine for Treating Unresectable Hepatocellular Carcinoma	NCT03652467	Hepatocellular ...	Conventional TA... Deferoxamine an...	18 Years -	Jinan Military General Hospital

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