Status:
COMPLETED
Heat Activated Liposomal Doxorubicin and Radiofrequency Ablation in Treating Patients With Primary or Metastatic Liver Tumors
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Liver Cancer
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
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. * ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00093444
Start Date
September 1 2004
End Date
January 1 2010
Last Update
March 15 2012
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
2
Queen Mary Hospital - Hong Kong
Hong Kong, China