Heat Activated Liposomal Doxorubicin and Radiofrequency Ablation in Treating Patients With Primary or Metastatic Liver Tumors

NCT ID: NCT00093444

Last Updated: 2012-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2010-01-31

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiofrequency ablation uses high-frequency electric current to kill tumor cells. Combining radiofrequency ablation with liposomal doxorubicin may increase the effectiveness of the drug and kill more tumor cells.

PURPOSE: This phase I trial is studying the best dose of liposomal doxorubicin when given with radiofrequency ablation in treating patients with primary or metastatic liver tumors.

Detailed Description

OBJECTIVES:

• Determine the maximum tolerated dose of heat activated doxorubicin HCl liposome when combined with radiofrequency ablation in patients with primary or metastatic tumors of the liver.
• Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.

OUTLINE: This is a dose-escalation study of heat activated doxorubicin HCl liposome.

Patients receive doxorubicin HCl liposome IV over 30 minutes. Approximately 15 minutes after the beginning of the doxorubicin HCl liposome infusion, patients undergo radiofrequency ablation with needles inserted into the tumor(s) and heated to the target temperature for approximately 12-60 minutes.

Cohorts of 3-6 patients receive escalating doses of heat activated doxorubicin HCl liposome until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.

Patients are followed at 28 days, every 3 months for 1 year, and then every 6 months for 2 years.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study within 2 years.

Conditions

Liver Cancer; Metastatic Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

lyso-thermosensitive liposomal doxorubicin

Intervention Type: DRUG

radiofrequency ablation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed tumor of the liver

• Primary or metastatic disease
• No more than 4 lesions
• No single lesion > 7 cm in maximum diameter
• Not a candidate for curative surgical resection due to tumor histology or prior surgery

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 3 months

Hematopoietic

• Platelet count ≥ 75,000/mm^3
• WBC ≥ 1,500/mm^3
• Hemoglobin ≥ 10 g/dL (transfusions to attain levels ≥ 10g/dL allowed)

Hepatic

• Bilirubin ≤ 2.0 mg/dL
• PT or PTT ≤ 1.5 times control (except for patients receiving anticoagulation therapy for an unrelated medical condition [e.g., atrial fibrillation])

Renal

• Creatinine ≤ 2.5 mg/dL

Cardiovascular

• See Hepatic
• Ejection fraction ≥ 50% by MUGA
• No congestive heart failure
• No myocardial infarction within the past 6 months
• No cerebral vascular accident within the past 6 months
• No life-threatening cardiac arrhythmia

Other

• Weight < 136 kg
• Glucose ≤ 300 mg/dL
• No uncontrolled diabetes
• No known serious uncontrolled reaction (e.g., anaphylaxis) to contrast agents used in this study
• No known allergy to egg or egg products
• No other serious medical illness
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent interferon
• No live vaccines (for immunosuppressed patients only) during and for 30 days after study treatment

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• See Disease Characteristics

Other

• More than 3 weeks since prior therapy for liver tumor(s)
• More than 3 weeks since prior systemic therapy for non-life-threatening extrahepatic disease and recovered
• No other concurrent systemic therapy
• No administration of any of the following medications during and for 30 days after study treatment:

• Cyclosporine
• Phenobarbital
• Phenytoin
• Streptozocin
• No concurrent administration of any of the following medications:

• Amphotericin B by injection
• Antithyroid agents for overactive thyroid
• Azathioprine
• Chloramphenicol
• Colchicine
• Flucytosine
• Ganciclovir
• Plicamycin
• Zidovudine
• Probenecid
• Sulfinpyrazone

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

National Institutes of Health Clinical Center (CC)

NIH

Sponsor Role: lead

Principal Investigators

Bradford Wood, MD

Role: STUDY_CHAIR

National Cancer Institute (NCI)

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, United States

Queen Mary Hospital - Hong Kong

Hong Kong, , China

Countries

United States; China

Other Identifiers

04-C-0263

Identifier Type: -

Identifier Source: secondary_id

CELSION-10403101

Identifier Type: -

Identifier Source: secondary_id

CDR0000387979

Identifier Type: -

Identifier Source: secondary_id

040263

Identifier Type: -

Identifier Source: org_study_id

NCT00090805

Identifier Type: -

Identifier Source: nct_alias