Heat Activated Liposomal Doxorubicin and Radiofrequency Ablation in Treating Patients With Primary or Metastatic Liver Tumors
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Cancer Metastatic Cancer |
Drug: lyso-thermosensitive liposomal doxorubicin Procedure: radiofrequency ablation |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I Dose Escalation Study Of Heat Activated Liposome Delivery Of Doxorubicin And Radiofrequency Ablation Of Primary And Metastatic Tumors Of The Liver |
- Maximum tolerated dose of heat-activated doxorubicin HCL liposome [ Designated as safety issue: Yes ]
- Pharmacokinetics and pharmacodynamics of heat-activated doxorubicin HCL liposome at 15, 30, 45, 60, 75, and 90 minutes; 2, 3, 4, 6, 24, and 46 hours; and 4 and 8 days following infusion [ Designated as safety issue: No ]
- Effects of ablative therapy on tumor blood flow and tumor vascular density as measured by MRI at 28 days following study completion [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2004 |
| Study Completion Date: | January 2010 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
| Bethesda, Maryland, United States, 20892-1182 | |
| China | |
| Queen Mary Hospital - Hong Kong | |
| Hong Kong, China | |
| Study Chair: | Bradford Wood, MD | National Cancer Institute (NCI) |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00093444 History of Changes |
| Obsolete Identifiers: | NCT00090805 |
| Other Study ID Numbers: | 040263, 04-C-0263, CELSION-10403101, CDR0000387979 |
| Study First Received: | October 6, 2004 |
| Last Updated: | March 14, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
advanced adult primary liver cancer liver metastases localized unresectable adult primary liver cancer recurrent adult primary liver cancer |
Additional relevant MeSH terms:
|
Liver Neoplasms Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
Neoplastic Processes Pathologic Processes Doxorubicin Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013