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

NCT ID: NCT01409733

Last Updated: 2011-08-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2012-12-31

Brief Summary

The Aim is to evaluate safety and efficacy of TACE with doxorubicin-loaded DC beads in melanoma patients with liver metastasis. This is a pilot study with the aim of recruiting 20 patients, this is a feasibility study. the patients profile is patients with stage IV Melanoma with liver metastases.

Conditions

Stage IV Melanoma Patients With Unresectable Liver Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stage IV melanoma patients

Group Type: EXPERIMENTAL

TACE using Drug Eluting Beads loaded with Doxorubicin

Intervention Type: DEVICE

100-300 microns DC Beads loaded with Doxorubicin (75mg of Doxorubixcin per vial)

Interventions

TACE using Drug Eluting Beads loaded with Doxorubicin

100-300 microns DC Beads loaded with Doxorubicin (75mg of Doxorubixcin per vial)

Intervention Type: DEVICE

Other Intervention Names

DC Bead; DebDox

Eligibility Criteria

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 ablation.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: collaborator

SLK Kliniken Heilbronn GmbH

OTHER

Sponsor Role: collaborator

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

SLK Klinikum Heilbronn

Principal Investigators

Philippe Pereira, MD

Role: PRINCIPAL_INVESTIGATOR

SLK Klninikum

Locations

SLK Klinikum

Heilbronn, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Philippe Pereira, MD

Role: CONTACT

philippe.pereira@slk-kliniken.de

+49 71 31 49-38 01

Facility Contacts

Philippe Pereira, MD

Role: primary

philippe.pereira@slk-kliniken.de

+ 49 7131 49 3801

Other Identifiers

Pereira-DE-2010

Identifier Type: -

Identifier Source: org_study_id