A Phase 1/2 Study of DENSPM (N1, N11-diethylnorspermine) in Patients With Unresectable Hepatocellular Carcinoma
DENSPM )
Adenocarcinoma+8
+ Carcinoma
+ Digestive System Diseases
Treatment Study
Summary
Study start date: March 1, 2004
Actual date on which the first participant was enrolled.Approximately 18-45 patients with Hepatocellular Carcinoma (HCC) will be treated with DENSPM at approximately 5 centers in the United States. First, we will be trying to determine the highest dose that can be given safely and is well tolerated (this is called the maximally tolerated dose, or the MTD, for short). Once that is established, we will enroll additional patients to learn more about potential side effects and to see whether DENSPM can slow the growth of HCC tumors. We also want to learn about the safety of DENSPM. Many medications used to treat cancer cause side effects (discomforts or illness). In this study, we want to understand what side effects occur in patients with HCC who are treated with DENSPM.Study was terminated after initial assessment of insufficient data to support clinical benefit in this population.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.38 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Histologically proven HCC, or if the patient is not a medically appropriate candidate for biopsy, then all of the following criteria must be met: A.History of cirrhosis or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV)infection. B.A focal liver lesion ≥ 3 cm on CT or MRI with arterial hypervascularization. C.Confirmation of the liver lesion by a second imaging modality (US/ CT/ MRI).D.AFP ≥1000 ng/ml, or ≥ 4000 ng/ml if Hepatitis B surface Ag positive. * For recurrent HCC, radiographic evidence of progression. * Not appropriate for curative therapy (surgical resection) or refuses potentially curative therapy * Measurable disease, defined as having at least one measurable intrahepatic tumor lesion (using Response Criteria in Solid Tumors \[RECIST\]). Prior therapy is acceptable only if there is documented progression of the selected measurable lesion(s) following completion of the therapy. * Required laboratory values * Renal function: serum creatinine ≤1.2mg/dL Hematologic function: leukocyte count ≥1,500/mm3, platelet count ≥50,000/mm3 Hepatic function: transaminases ≤5x upper limit normal (ULN), albumin ≥2.0g/dL, total bilirubin ≤3.5mg/dL Sodium: ≥130mEq/L * Karnofsky Performance Status of ≥ 60% * CLIP Score ≤ 3 * If female and of childbearing potential, must use an effective method of contraception * Willing and able to provide written informed consent Exclusion Criteria: * Has received localized therapy (e.g., radiotherapy, RFA, injection therapy, or chemoembolization)within 6 weeks prior to treatment, Day1. Prior local lesion-specific radiotherapy is acceptable only if the treated lesion(s) is/are not the only source of measurable disease or there is documented progression of the treated lesion(s) following completion of the therapy. * Has received any other systemic therapy for HCC within 3 weeks prior to treatment, Day 1. Prior therapy is acceptable only if there is documented progression following completion of the therapy. * Has received another investigational therapy within 30 days prior to study entry * Has any unstable serious or life-threatening medical condition, other than HCC (e.g., unstable angina, other cancer diagnosis with the exception of basal cell carcinoma, or patients with prior malignancy except for adequately treated basal cell carcinoma(s), in situ cervical cancer, or other cancer for which the patient has been disease-free for five or more years) * Newly noted clinically significant electrocardiogram (ECG) abnormality * Clinically significant abnormal laboratory result that is not consistent with patient's clinical course * Active gastrointestinal bleeding resulting in clinically significant hemodynamic changes or a reduction in hemoglobin. * Active inflammatory bowel disease (IBD) and/or active gastric or duodenal ulcer disease * Has a history of central nervous system (CNS) metastases, seizure disorder or neurological exam finding suggestive of CNS metastases * Has Stage B or C liver cirrhosis according to Child-Pugh-Turcotte Classification * Has ascites refractory to diuretic therapy * Has any contraindication for MRI procedure * If female of childbearing potential, has a positive serum HCG * If female, is lactating
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 8 locations
Massachusetts General Hospital
Boston, United StatesBeth Israel Deaconess Medical Center
Boston, United StatesDana Farber Partners Cancer Care
Boston, United States