Doxorubicin and Interleukin-2 in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

This study has been completed.
Sponsor:
Information provided by:
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00004248
First received: January 28, 2000
Last updated: March 3, 2011
Last verified: March 2011
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill liver cancer cells.

PURPOSE: Phase II trial to study the effectiveness of doxorubicin and interleukin- 2 in treating patients who have liver cancer that cannot be removed by surgery.


Condition Intervention Phase
Liver Cancer
Biological: aldesleukin
Drug: doxorubicin hydrochloride
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: A Low Dose Schedule of Adriamycin and Protracted Infusion of Recombinant Interleukin-2: A Phase II Study of Immunotherapy in Unresectable Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Enrollment: 24
Study Start Date: July 1999
Study Completion Date: May 2001
Primary Completion Date: June 2000 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Evaluate the immunological response to doxorubicin and protracted recombinant interleukin-2 in terms of alterations in hepatocellular carcinoma specific cytotoxic T cells detectable in peripheral blood in patients with unresectable hepatocellular carcinoma. II. Determine the toxicity of this treatment regimen in this patient population. III. Determine the tumor response to this regimen in terms of changes in alpha fetoprotein and tumor size measured by CT scan in these patients. IV. Determine the progression free survival and overall survival of this patient population treated with this regimen. V. Determine the correlation between immunological response, tumor response, progression free survival and overall survival in these patients.

OUTLINE: Patients receive doxorubicin IV over 3-5 minutes on day 1 and recombinant interleukin-2 (IL-2) IV continuously beginning on day 5 and continuing until day 57. Patients achieving partial or complete clinical response regardless of immunological response and patients with stable disease and an immunological response continue on IL-2 therapy continuously until day 92. Patients with stable disease and no immunological response receive an additional dose of doxorubicin on day 57 and then continue on IL-2 until day 92. Patients who are clinically eligible with progressive disease and an immunological response continue IL-2 therapy as above. Patients are followed at 2 weeks and then monthly thereafter.

PROJECTED ACCRUAL: A total of 24-30 patients will be accrued for this study within approximately 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven hepatocellular carcinoma OR Elevation of alpha fetoprotein (AFP) (greater than 400 ng/mL) in the presence of a space occupying lesion in the liver with known chronic liver disease Lesion must be easily biopsied Unresectable disease Bidimensionally measurable disease by radiography OR Evaluable disease with elevated AFP Okuda stage I disease Tumor size less than 50% of liver No ascites Albumin greater than 3 g/dL Bilirubin less than 2 mg/dL OR Okuda stage II disease Bilirubin as in stage I If ascites present, albumin must be greater than 3 g/dL

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Hemoglobin at least 9.0 g/dL Neutrophil count at least 1,500/mm3 Platelet count at least 80,000/mm3 Hepatic: See Disease Characteristics SGOT/SGPT no greater than 4 times upper limit of normal Any cause of underlying liver disease including hepatitis B or C allowed Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No poor cardiac function No myocardial infarction within the past 6 months No poorly controlled arrhythmia No congestive heart failure LVEF at least 45% by MUGA Other: No active hepatic encephalopathy No other active malignancies except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix HIV negative No immunodeficiency Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior immunotherapy, including interferon Chemotherapy: No prior systemic or intra arterial doxorubicin At least 6 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: At least 4 weeks since prior investigational therapy

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004248

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Study Chair: Lawrence P. Leichman, MD Albany Medical College
  More Information

Additional Information:
No publications provided

Responsible Party: Lawrance Liechman,MD, Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00004248     History of Changes
Other Study ID Numbers: CDR0000067494, RPCI-RP-9814
Study First Received: January 28, 2000
Last Updated: March 3, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
localized unresectable adult primary liver cancer
recurrent adult primary liver cancer
adult primary hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Doxorubicin
Liposomal doxorubicin
Interleukin-2
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014