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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Heidelberg University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University Hospital Tuebingen
SLK Heilbronn
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT01409733
First received: August 3, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TACE With Drug Eluting Beads Loaded With Doxorubicin in Liver Metastases From Melanoma Patients

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Proportion of patients completing scheduled treatment plan [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Safety: Adverse Events Efficacy: Response to Treatment


Estimated Enrollment: 20
Study Start Date: June 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01409733

Contacts
Contact: Philippe Pereira, MD +49 71 31 49-38 01 philippe.pereira@slk-kliniken.de

Locations
Germany
SLK Klinikum Recruiting
Heilbronn, Germany, 74078
Contact: Philippe Pereira, MD    + 49 7131 49 3801    philippe.pereira@slk-kliniken.de   
Principal Investigator: Philippe Pereira, MD         
Sponsors and Collaborators
Heidelberg University
University Hospital Tuebingen
SLK Heilbronn
Investigators
Principal Investigator: Philippe Pereira, MD SLK Klninikum
  More Information

No publications provided

Responsible Party: Prof. Philippe Pereira, SLK Klinikum Heilbronn
ClinicalTrials.gov Identifier: NCT01409733     History of Changes
Other Study ID Numbers: Pereira-DE-2010
Study First Received: August 3, 2011
Last Updated: August 3, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on September 30, 2014