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

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.

Study Overview

• Status: Unknown
• Conditions: Stage IV Melanoma Patients With Unresectable Liver Metastases
• Intervention / Treatment: Device: TACE using Drug Eluting Beads loaded with Doxorubicin

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Philippe Pereira, MD; Phone Number: +49 71 31 49-38 01; Email: philippe.pereira@slk-kliniken.de

Study Locations

• Germany
  • Heilbronn, Germany, 74078
    • Recruiting
    • SLK Klinikum
    • Contact: Philippe Pereira, MD; Phone Number: + 49 7131 49 3801; Email: philippe.pereira@slk-kliniken.de
    • Principal Investigator: Philippe Pereira, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stage IV melanoma patients	Device: TACE using Drug Eluting Beads loaded with Doxorubicin; 100-300 microns DC Beads loaded with Doxorubicin (75mg of Doxorubixcin per vial); Other Names: DC Bead; DebDox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients completing scheduled treatment plan	Safety: Adverse Events Efficacy: Response to Treatment	12 months

Collaborators and Investigators

• Sponsor: Heidelberg University
• Collaborators: University Hospital Tuebingen; SLK Kliniken Heilbronn GmbH
• Investigators: Principal Investigator: Philippe Pereira, MD, SLK Klninikum

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Anticipated): September 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: August 3, 2011
• First Submitted That Met QC Criteria: August 3, 2011
• First Posted (Estimate): August 4, 2011

Study Record Updates

• Last Update Posted (Estimate): August 4, 2011
• Last Update Submitted That Met QC Criteria: August 3, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neoplastic Processes; Neuroendocrine Tumors; Nevi and Melanomas; Neoplasm Metastasis; Melanoma; Liver Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Doxorubicin
• Other Study ID Numbers: Pereira-DE-2010