A Phase I Dose Escalation Study Of Heat Activated Liposome Delivery Of Doxorubicin And Radiofrequency Ablation Of Primary And Metastatic Tumors Of The Liver
18 Years
N/A
Both
Liver Cancer, Metastatic Cancer
Trial Information
A Phase I Dose Escalation Study Of Heat Activated Liposome Delivery Of Doxorubicin And Radiofrequency Ablation Of Primary And Metastatic Tumors Of The Liver
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.
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose of heat-activated doxorubicin HCL liposome
Safety Issue:
Yes
Principal Investigator
Bradford Wood, MD
Investigator Role:
Study Chair
Investigator Affiliation:
National Cancer Institute (NCI)
Authority:
United States: Food and Drug Administration
Study ID:
040263
NCT ID:
NCT00093444
Start Date:
September 2004
Completion Date:
January 2010
Related Keywords:
- Liver Cancer
- Metastatic Cancer
- advanced adult primary liver cancer
- liver metastases
- localized unresectable adult primary liver cancer
- recurrent adult primary liver cancer
- Liver Neoplasms
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
Name | Location |
|---|---|
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Bethesda, Maryland 20892-1182 |
