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Doxorubicin and Interleukin-2 in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
This study is ongoing, but not recruiting participants.
First Received: January 28, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Roswell Park Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004248
  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 II

MedlinePlus related topics: Cancer Liver Cancer Surgery
Drug Information available for: Doxorubicin Doxorubicin hydrochloride Interleukin-2 Aldesleukin Myocet
U.S. FDA Resources
Study Type: Interventional
Study Design: 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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: July 1999
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
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

Study ID Numbers: CDR0000067494, RPCI-RP-9814, NCI-G99-1663
Study First Received: January 28, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00004248     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
localized unresectable adult primary liver cancer
recurrent adult primary liver cancer
adult primary hepatocellular carcinoma

Study placed in the following topic categories:
Liver Diseases
Anti-HIV Agents
Digestive System Neoplasms
Carcinoma, Hepatocellular
Antiviral Agents
Recurrence
Doxorubicin
Carcinoma
Liver Neoplasms
Anti-Bacterial Agents
Digestive System Diseases
Aldesleukin
Anti-Retroviral Agents
Analgesics, Non-Narcotic
Interleukin-2
Gastrointestinal Neoplasms
Peripheral Nervous System Agents
Analgesics
Adenocarcinoma
Hepatocellular Carcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Anti-Infective Agents
Liver Diseases
Carcinoma, Hepatocellular
Antineoplastic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Liver Neoplasms
Neoplasms by Site
Anti-Retroviral Agents
Sensory System Agents
Therapeutic Uses
Analgesics
Digestive System Neoplasms
Neoplasms by Histologic Type
Anti-HIV Agents
Antiviral Agents
Doxorubicin
Pharmacologic Actions
Carcinoma
Neoplasms
Aldesleukin
Digestive System Diseases
Interleukin-2
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Adenocarcinoma
Central Nervous System Agents
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009