Stage IV MelanomaDEBDOXNCT01010984
LC Bead Embolization Agent With Doxorubicin in the Treatment Liver Metastasis From Melanoma
A study testing LC beads loaded with Doxorubicin in people with Stage IV Melanoma, run by Robert C. Martin at 3 sites in United States.
Trial summary
The purpose of this study is to determine if LC beads loaded with Doxorubicin are a safe and effective treatment for melanoma that has spread to the liver. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Stage IV Melanoma
- What is being tested?
- LC 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
- 3 sitesUnited States
- Study dates
- Sep 2009to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- 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
- Any contraindication for doxorubicin administration:
- WBC <3000 cells/mm3
- Neutrophils <1500 cells/mm3
- Deficient cardiac function defined as a LVEF of <50% normal
Trial locations and contacts
3 sites in 1 country.
United States3 sites
MD Anderson Cancer Center
Houston, Texas, 77230
University of Louisville
Louisville, Kentucky, 40202
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Transcatheter Arterial Chemoembolization With Doxorubicin-loaded LC Beads in the Treatment of Liver-dominant Metastases in Patients With Stage IV Metastatic Melanoma
The purpose of this study is to determine if LC beads loaded with Doxorubicin are a safe and effective treatment for melanoma that has spread to the liver.
Read the detailed description
In this study, trans-arterial chemoembolization will be used to deliver LC beads loaded with Doxorubicin directly into liver tumors resulting from malignant melanoma.
- Conditions
- Stage IV Melanoma
- Being tested
- LC beads loaded with Doxorubicin
- Keywords
- metastatic melanoma, stage IV melanoma, metastatic melanoma to the liver
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LC beads loaded with DoxorubicinDevice
During each TACE, 2 vials (1 vial, 75mg Doxorubicin) of 100-300 micrometer size LC beads loaded with doxorubicin will be delivered to the liver tumor(s). Total Doxorubicin dose for each TACE is 150mg
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter Arterial Chemoembolization | Experimental | TACE using LC beads loaded with Doxorubicin Receives: Device: LC beads loaded with Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Adverse events were collected from all 20 subjects.
Measured: Date of surgery through 2 years post procedure or until patient death
Secondary outcomes (1)
Percentage of Tumor Response
Progression is determined using Modified Response Evaluation Criteria in Solid Tumors (mRECIST). Progressive disease is defined as at least 20% increase in the sum of the longest target lesions, taking as reference the smallest sum longest diameter recorded since start of treatment OR appearance of one or more new lesions greater then 1cm in size. Percentage of tumor response will be assessed up to 1 year post treatment.
Measured: Percentage of tumor response assessed up to 1 year post treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stage IV MelanomaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert C. Martin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Robert C. Martin, University of Louisville
- Investigators
- Robert CG Martin, MD, PhD, Study director, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010984
- Sponsor's protocol ID
- G090097
- Acronym
- DEBDOX
- Status last verified
- Mar 2018
- First submitted
- 4 Nov 2009
- Last updated
- 25 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rostas JW, Tam AL, Sato T, Scoggins CR, McMasters KM, Martin RCG 2nd. Health-related quality of life during trans-arterial chemoembolization with drug-eluting beads loaded with doxorubicin (DEBDOX) for unresectable hepatic metastases from ocular melanoma. Am J Surg. 2017 Nov;214(5):884-890. doi: 10.1016/j.amjsurg.2017.07.007. Epub 2017 Jul 21.
PubMed 28754534Rostas J, Tam A, Sato T, Kelly L, Tatum C, Scoggins C, McMasters K, Martin RCG 2nd. Image-Guided Transarterial Chemoembolization With Drug-Eluting Beads Loaded with Doxorubicin (DEBDOX) for Unresectable Hepatic Metastases from Melanoma: Technique and Outcomes. Cardiovasc Intervent Radiol. 2017 Sep;40(9):1392-1400. doi: 10.1007/s00270-017-1651-z. Epub 2017 May 15.
PubMed 28508253
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Arterial Chemoembolization With Doxorubicin-loaded LC Beads in the Treatment of Liver-dominant Metastases in Patients With Stage IV Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT01010984
- Acronym / sponsor ID
- DEBDOX / G090097
- Conditions
- Stage IV Melanoma
- Keywords
- metastatic melanoma, stage IV melanoma, metastatic melanoma to the liver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Robert C. MartinUniversity, hospital or other
- Collaborators
- University of Louisville, Thomas Jefferson University, M.D. Anderson Cancer Center
- Study start
- Sep 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 10 Nov 2009 (estimated)
- Results
- Posted 7 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if LC beads loaded with Doxorubicin are a safe and effective treatment for melanoma that has spread to the liver.
Detailed description
In this study, trans-arterial chemoembolization will be used to deliver LC beads loaded with Doxorubicin directly into liver tumors resulting from malignant melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcatheter Arterial Chemoembolization | Experimental | Device: LC beads loaded with DoxorubicinTACE using LC beads loaded with Doxorubicin |
Who may qualify
- Ages
- 18 to 99 years
- 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 (17 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 |
|---|---|---|
| LC beads loaded with DoxorubicinDuring each TACE, 2 vials (1 vial, 75mg Doxorubicin) of 100-300 micrometer size LC beads loaded with doxorubicin will be delivered to the liver tumor(s). Total Doxorubicin dose for each TACE is 150mg | Device | Transcatheter Arterial Chemoembolization |
Primary outcome
Incidence of Adverse Events
Time frame: Date of surgery through 2 years post procedure or until patient death
Adverse events were collected from all 20 subjects.
1 secondary outcome
Percentage of Tumor Response
Time frame: Percentage of tumor response assessed up to 1 year post treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28754534Rostas JW, Tam AL, Sato T, Scoggins CR, McMasters KM, Martin RCG 2nd. Health-related quality of life during trans-arterial chemoembolization with drug-eluting beads loaded with doxorubicin (DEBDOX) for unresectable hepatic metastases from ocular melanoma. Am J Surg. 2017 Nov;214(5):884-890. doi: 10.1016/j.amjsurg.2017.07.007. Epub 2017 Jul 21.
- Derived from this study: PubMed 28508253Rostas J, Tam A, Sato T, Kelly L, Tatum C, Scoggins C, McMasters K, Martin RCG 2nd. Image-Guided Transarterial Chemoembolization With Drug-Eluting Beads Loaded with Doxorubicin (DEBDOX) for Unresectable Hepatic Metastases from Melanoma: Technique and Outcomes. Cardiovasc Intervent Radiol. 2017 Sep;40(9):1392-1400. doi: 10.1007/s00270-017-1651-z. Epub 2017 May 15.
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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.
Robert CG Martin, MD, PhD study director
University of Louisville
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LC beads loaded with Doxorubicin in people with Stage IV Melanoma, run by Robert C. Martin at 3 sites in United States.
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 17 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: finished, as of the sponsor's last update on 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: Date of surgery through 2 years post procedure or until patient death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01010984, which also lists 2 linked publications.
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 25 Oct 2018.