Clinical trial · Interventional
Heat Activated Liposomal Doxorubicin and Radiofrequency Ablation in Treating Patients With Primary or Metastatic Liver Tumors
A Phase I Dose Escalation Study Of Heat Activated Liposome Delivery Of Doxorubicin And Radiofrequency Ablation Of Primary And Metastatic Tumors Of The Liver
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lyso-thermosensitive liposomal doxorubicin | Drug | — | UNRESOLVED |
| radiofrequency ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Maximum tolerated dose of heat-activated doxorubicin HCL liposome
- 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
Secondary outcomes (1)
- measure
- Effects of ablative therapy on tumor blood flow and tumor vascular density as measured by MRI at 28 days following study completion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available