Expired Study
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Bethesda, Maryland 20892


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.


Study summary:

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.


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


Study is Available At:


Original ID:

040263


NCT ID:

NCT00093444


Secondary ID:

04-C-0263


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institutes of Health Clinical Center (CC)


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Bradford Wood, MD
Study Chair
National Cancer Institute (NCI)

Study Dates

Start Date:September 2004
Completion Date:January 2010
Completion Type:Actual
Verification Date:March 2012
Last Changed Date:March 14, 2012
First Received Date:October 6, 2004

Study Outcomes

Outcome Type:Primary Outcome
Measure:Maximum tolerated dose of heat-activated doxorubicin HCL liposome
Safety Issues:True
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Effects of ablative therapy on tumor blood flow and tumor vascular density as measured by MRI at 28 days following study completion
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:lyso-thermosensitive liposomal doxorubicin
Intervention Type:Procedure
Name:radiofrequency ablation

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institutes of Health Clinical Center (CC)
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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