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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01409733
Recruitment Status : Unknown
Verified July 2011 by Heidelberg University.
Recruitment status was:  Recruiting
First Posted : August 4, 2011
Last Update Posted : August 4, 2011
University Hospital Tuebingen
SLK Heilbronn
Information provided by:
Heidelberg University

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.

Condition or disease Intervention/treatment Phase
Stage IV Melanoma Patients With Unresectable Liver Metastases Device: TACE using Drug Eluting Beads loaded with Doxorubicin Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TACE With Drug Eluting Beads Loaded With Doxorubicin in Liver Metastases From Melanoma Patients
Study Start Date : June 2010
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : December 2012

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

Primary Outcome Measures :
  1. Proportion of patients completing scheduled treatment plan [ Time Frame: 12 months ]
    Safety: Adverse Events Efficacy: Response to Treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01409733

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Contact: Philippe Pereira, MD +49 71 31 49-38 01

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SLK Klinikum Recruiting
Heilbronn, Germany, 74078
Contact: Philippe Pereira, MD    + 49 7131 49 3801   
Principal Investigator: Philippe Pereira, MD         
Sponsors and Collaborators
Heidelberg University
University Hospital Tuebingen
SLK Heilbronn
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Principal Investigator: Philippe Pereira, MD SLK Klninikum

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Responsible Party: Prof. Philippe Pereira, SLK Klinikum Heilbronn Identifier: NCT01409733     History of Changes
Other Study ID Numbers: Pereira-DE-2010
First Posted: August 4, 2011    Key Record Dates
Last Update Posted: August 4, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
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Neoplasm Metastasis
Liver Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action