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A Phase I Dose Escalation Study Of Heat Activated Liposome Delivery Of Doxorubicin And Radiofrequency Ablation Of Primary And Metastatic Tumors Of The Liver


Phase 1
18 Years
N/A
Not Enrolling
Both
Liver Cancer, Metastatic Cancer

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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 OfficeBethesda, Maryland  20892-1182