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TACE With Drug Eluting Beads Loaded With Doxorubicin in Liver Metastases From Melanoma Patients

Phase 1/Phase 2
18 Years
Open (Enrolling)
Stage IV Melanoma Patients With Unresectable Liver Metastases

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Trial Information

TACE With Drug Eluting Beads Loaded With Doxorubicin in Liver Metastases From Melanoma Patients

Inclusion Criteria:

1. Patients with unresectable, measurable disease defined as at least one lesion that
can be accurately and serially measured per the modified RECIST and EASL criteria
(2D/3D-EASL) or MRI (Extent of Necrosis)

2. Patients ≥ 18 years of age, > 35kg, of any race or sex, who have histological or
radiological proof of melanoma to the liver

3. ECOG performance status < 3.

4. Patient chooses to participate and has signed the informed consent document.

5. Patients with unilobar disease who can be treated superselectively in a single
session or patients with bilobar disease who can have both lobes able to be treated
within 3 - 4 weeks in separate sessions.

6. Patients with patent main portal vein.

7. Ocular melanoma is allowed.

8. Patients with clinically and radiologically stable brain metastasis from melanoma can
be included.

9. Patients with liver dominant disease (>50% overall tumor burden).

10. Prior systemic therapy for metastatic disease is allowed.

11. Non-pregnant with an acceptable contraception in premenopausal women and fertile men.

12. Hematological function: ANC ≥1.5 x 109/L, platelets ≥ 75 x 109/L, INR<1.3 (patients
on therapeutic anticoagulants are not eligible).

13. Adequate renal function: Creatinine ≤2.0mg/dl and GFR >30.

14. Adequate liver function: total bilirubin ≤ 2.5 mg/dl, ALT, AST ≤ 5 times ULN, albumin
≥ 2.5mg/dl.

15. All toxic effects of prior therapy must have resolved to ≤ Grade 1 unless otherwise
specified above

Exclusion Criteria:

1. Women who are pregnant or breast feeding.

2. Patients eligible for curative treatment such as resection or radiofrequency

3. Active bacterial, viral or fungal infection within 72 hours of study entry.

4. Previous or concurrent cancer that is distinct in primary site or histology from the
cancer being evaluated in this study except cervical carcinoma in situ, treated basal
cell carcinoma, superficial bladder tumors (TA, Tis & Ti) or any cancer curatively
treated < 5 years prior to study entry.

5. Contraindication to hepatic artery embolization procedures:

- Severe peripheral vascular disease precluding catheterization.

6. - Large shunt as determined by the investigator (pretesting with TcMAA not
required) at the time of first angiogram.

7. -Hepatofugal blood flow.

8. -Main portal vein occlusion (e.g. thrombus or tumor).

9. Recovery from major trauma including surgery within 4 weeks prior to administration
of study treatment.

10. Allergy to contrast media that cannot be managed with standard care (e.g. steroids),
making magnetic resonance imaging (MRI) or computed tomography (CT) contraindicated.

11. Advanced liver disease (> 80% liver replacement).

12. Other significant medical or surgical condition, or any medication or treatment that
would place the patient at undue risk and that would preclude the safe use of
chemoembolization or would interfere with study participation.

13. Ongoing systemic cancer treatment.

14. Any contraindication for Doxorubicin administration:

15. WBC <3000 cells/mm3

16. Neutrophils <1500 cells/mm3

17. Deficient cardiac function defined as a LVEF of <50% normal

18. Allergy to Doxorubicin.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients completing scheduled treatment plan

Outcome Description:

Safety: Adverse Events Efficacy: Response to Treatment

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Philippe Pereira, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

SLK Klninikum


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

June 2010

Completion Date:

December 2012

Related Keywords:

  • Stage IV Melanoma Patients With Unresectable Liver Metastases
  • Melanoma
  • Neoplasm Metastasis
  • Liver Neoplasms