Stage IV Melanoma Patients With Unresectable Liver MetastasesPhase 1/2NCT01409733
TACE With Drug Eluting Beads Loaded With Doxorubicin in Liver Metastases From Melanoma Patients
A Phase 1/2 study testing TACE using Drug Eluting Beads loaded with Doxorubicin in people with Stage IV Melanoma Patients With Unresectable Liver Metastases, run by Heidelberg University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IV Melanoma Patients With Unresectable Liver Metastases
- What is being tested?
- TACE using Drug Eluting Beads loaded with Doxorubicin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2010to Dec 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- Patients ≥ 18 years of age, > 35kg, of any race or sex, who have histological or radiological proof of melanoma to the liver
- ECOG performance status < 3.
- Patient chooses to participate and has signed the informed consent document.
- 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.
- Patients with patent main portal vein.
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- Ocular melanoma is allowed.
- Patients with clinically and radiologically stable brain metastasis from melanoma can be included.
- Patients with liver dominant disease (>50% overall tumor burden).
- Prior systemic therapy for metastatic disease is allowed.
- Non-pregnant with an acceptable contraception in premenopausal women and fertile men.
- Hematological function: ANC ≥1.5 x 109/L, platelets ≥ 75 x 109/L, INR<1.3 (patients on therapeutic anticoagulants are not eligible).
- Adequate renal function: Creatinine ≤2.0mg/dl and GFR >30.
- Adequate liver function: total bilirubin ≤ 2.5 mg/dl, ALT, AST ≤ 5 times ULN, albumin ≥ 2.5mg/dl.
- All toxic effects of prior therapy must have resolved to ≤ Grade 1 unless otherwise specified above
Who cannot join
- Women who are pregnant or breast feeding.
- Patients eligible for curative treatment such as resection or radiofrequency ablation.
- Active bacterial, viral or fungal infection within 72 hours of study entry.
- 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.
- Contraindication to hepatic artery embolization procedures:
- Severe peripheral vascular disease precluding catheterization.
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- - Large shunt as determined by the investigator (pretesting with TcMAA not required) at the time of first angiogram.
- -Hepatofugal blood flow.
- -Main portal vein occlusion (e.g. thrombus or tumor).
- Recovery from major trauma including surgery within 4 weeks prior to administration of study treatment.
- Allergy to contrast media that cannot be managed with standard care (e.g. steroids), making magnetic resonance imaging (MRI) or computed tomography (CT) contraindicated.
- Advanced liver disease (> 80% liver replacement).
- 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.
- Ongoing systemic cancer treatment.
- Any contraindication for Doxorubicin administration:
- WBC <3000 cells/mm3
- Neutrophils <1500 cells/mm3
- Deficient cardiac function defined as a LVEF of <50% normal
- Allergy to Doxorubicin.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
SLK Klinikum
Heilbronn, 74078
Philippe Pereira, MD, + 49 7131 49 3801, philippe.pereira@slk-kliniken.de
Philippe Pereira, MD
About this study
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.
- Being tested
- TACE using Drug Eluting Beads loaded with Doxorubicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACE using Drug Eluting Beads loaded with DoxorubicinDevice
Also called DC Bead, DebDox
100-300 microns DC Beads loaded with Doxorubicin (75mg of Doxorubixcin per vial)
| Study group | Role | What they receive |
|---|---|---|
| Stage IV melanoma patients | Experimental | Not described Receives: Device: TACE using Drug Eluting Beads loaded with Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients completing scheduled treatment plan
Safety: Adverse Events Efficacy: Response to Treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startJun 2010
- Primary completionSep 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV Melanoma Patients With Unresectable Liver MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen, SLK Kliniken Heilbronn GmbH
- Investigators
- Philippe Pereira, MD, Principal investigator, SLK Klninikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01409733
- Sponsor's protocol ID
- Pereira-DE-2010
- Status last verified
- Jul 2011
- First submitted
- 3 Aug 2011
- Last updated
- 4 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TACE With Drug Eluting Beads Loaded With Doxorubicin in Liver Metastases From Melanoma Patients
- ClinicalTrials.gov ID
- NCT01409733
- Acronym / sponsor ID
- Pereira-DE-2010
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- University Hospital Tuebingen, SLK Kliniken Heilbronn GmbH
- Study start
- Jun 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 4 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stage IV melanoma patients | Experimental | Device: TACE using Drug Eluting Beads loaded with Doxorubicin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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)
- Patients ≥ 18 years of age, > 35kg, of any race or sex, who have histological or radiological proof of melanoma to the liver
- ECOG performance status < 3.
- Patient chooses to participate and has signed the informed consent document.
- 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.
Key exclusion criteria (19 listed)
- Women who are pregnant or breast feeding.
- Patients eligible for curative treatment such as resection or radiofrequency ablation.
- Active bacterial, viral or fungal infection within 72 hours of study entry.
- 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.
- Contraindication to hepatic artery embolization procedures:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TACE using Drug Eluting Beads loaded with DoxorubicinAlso: DC Bead, DebDox100-300 microns DC Beads loaded with Doxorubicin (75mg of Doxorubixcin per vial) | Device | Stage IV melanoma patients |
Primary outcome
Proportion of patients completing scheduled treatment plan
Time frame: 12 months
Safety: Adverse Events Efficacy: Response to Treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Pereira, MD principal investigator
SLK Klninikum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TACE using Drug Eluting Beads loaded with Doxorubicin in people with Stage IV Melanoma Patients With Unresectable Liver Metastases, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe Pereira, MD (+49 71 31 49-38 01, philippe.pereira@slk-kliniken.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients completing scheduled treatment plan (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2011.