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A Phase 1/2 Study of DENSPM (N1, N11-diethylnorspermine) in Patients With Unresectable Hepatocellular Carcinoma

Phase 1/Phase 2
18 Years
Not Enrolling
Carcinoma, Hepatocellular

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Trial Information

A Phase 1/2 Study of DENSPM (N1, N11-diethylnorspermine) in Patients With Unresectable Hepatocellular Carcinoma

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the MTD, dose limiting toxicities and overall safety profile of DENSPM intravenous infusion in patients with unresectable HCC.

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2004

Completion Date:

January 2008

Related Keywords:

  • Carcinoma, Hepatocellular
  • Carcinoma, Hepatocellular
  • Carcinoma
  • Carcinoma, Hepatocellular



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Mary Crowley Medical Research Center Dallas, Texas  75246
University of Virginia Charlottesville, Virginia  22908
Vanderbilt University School of Medicine Nashville, Tennessee  37232-6307
McGuire VA Medical Center Richmond, Virginia  23249
University of Illinois- Chicago Chicago, Illinois  60612-7323
Dana Farber Partners Cancer Care Boston, Massachusetts