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

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institutes of Health Clinical Center (CC)
• Collaborator: National Cancer Institute (NCI)
• Treatments: Doxorubicin; Liposomal doxorubicin

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