Metastatic MelanomaPhase 1NCT01032122
Rituximab in Metastatic Melanoma
A Phase 1 study testing rituximab in people with Metastatic Melanoma, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The purpose of this study is to determine whether rituximab as an adjuvant therapy in clinical stage IIIc / IV (no evidence of disease, AJCC (American Joint Committee on Cancer) 2002) melanoma patients is safe and prolongs overall survival and disease-free interval. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2007to May 2011
- Phase
- Phase 1
- 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
- Histologically verified non-ocular melanoma stage IIIc/IV, no evidence of disease
Who cannot join
- ECOG (Eastern Cooperative Oncology Group) performance status > 2
- Ocular melanoma
- Immunodeficiency syndromes or hypogammaglobulinaemia
- Active autoimmune diseases
- Treatment with immunosuppressive agents other than steroids
- Depressed bone marrow function (Leukopenia <3000, platelet count <100.000)
Show all 11Show fewer
- Cardiac insufficiency NYHA (New York Heart Association) IV
- active Hepatitis B,C, or HIV infection
- Pregnancy or lactation
- Interstitial pulmonary disease
- Former treatment with anti-CD20 antibody
Trial locations and contacts
1 site in 1 country.
Austria1 site
General Hospital Vienna, Dep. of Dermatology, Division of Immunology and Infectious Diseases
Vienna, 1090
About this study
Official title: Efficacy and Safety of Rituximab, an Anti-CD20 (Cluster of Differentiation Antigen 20) Therapeutic Agent, in Metastatic Melanoma: a Pilot Study
The purpose of this study is to determine whether rituximab as an adjuvant therapy in clinical stage IIIc / IV (no evidence of disease, AJCC (American Joint Committee on Cancer) 2002) melanoma patients is safe and prolongs overall survival and disease-free interval.
- Conditions
- Metastatic Melanoma
- Being tested
- rituximab
- Keywords
- melanoma, rituximab, metastatic, stage IIIc/IV, stem cell, overall survival, disease free interval, anti-CD20 therapy
- Medical subject headings
- Melanoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabDrug
Also called mabthera, rituxan
induction phase: 375mg/m² qw, 4wks; followed by maintenance phase: 375mg/m², every 8 wks; duration: 2 years.
| Study group | Role | What they receive |
|---|---|---|
| rituximab | Experimental | Not described Receives: Drug: rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free interval
Measured: 42 months
Secondary outcomes (1)
overall survival
Measured: 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startOct 2007
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: the only reason is that recruitment was not sufficient to meet the planned patient numbers, because complete remissions are still infrequent.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephan N. Wagner, MD, Medical University of Vienna
- Investigators
- Stephan Wagner, MD, Principal investigator, Med Univ ViennaAlice Pinc, MD, Principal investigator, Medical Univ Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032122
- Sponsor's protocol ID
- MIMM1
- Status last verified
- Apr 2013
- First submitted
- 19 Sep 2009
- Last updated
- 25 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Rituximab, an Anti-CD20 (Cluster of Differentiation Antigen 20) Therapeutic Agent, in Metastatic Melanoma: a Pilot Study
- ClinicalTrials.gov ID
- NCT01032122
- Acronym / sponsor ID
- MIMM1
- Conditions
- Metastatic Melanoma
- Keywords
- melanoma, rituximab, metastatic, stage IIIc/IV, stem cell, overall survival, disease free interval, anti-CD20 therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the only reason is that recruitment was not sufficient to meet the planned patient numbers, because complete remissions are still infrequent.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 15 Dec 2009 (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 purpose of this study is to determine whether rituximab as an adjuvant therapy in clinical stage IIIc / IV (no evidence of disease, AJCC (American Joint Committee on Cancer) 2002) melanoma patients is safe and prolongs overall survival and disease-free interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rituximab | Experimental | Drug: rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Histologically verified non-ocular melanoma stage IIIc/IV, no evidence of disease
Key exclusion criteria (11 listed)
- ECOG (Eastern Cooperative Oncology Group) performance status > 2
- Ocular melanoma
- Immunodeficiency syndromes or hypogammaglobulinaemia
- Active autoimmune diseases
- Treatment with immunosuppressive agents other than steroids
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 |
|---|---|---|
| rituximabAlso: mabthera, rituxaninduction phase: 375mg/m² qw, 4wks; followed by maintenance phase: 375mg/m², every 8 wks; duration: 2 years. | Drug | rituximab |
Primary outcome
disease-free interval
Time frame: 42 months
1 secondary outcome
overall survival
Time frame: 42 months
Results and safety
The study was stopped early (reason given: the only reason is that recruitment was not sufficient to meet the planned patient numbers, because complete remissions are still infrequent.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2013.
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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.
Stephan Wagner, MD principal investigator
Med Univ Vienna
Alice Pinc, MD principal investigator
Medical Univ Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rituximab in people with Metastatic Melanoma, run by Medical University of Vienna at 1 site in Austria.
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 1 inclusion and 11 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: stopped early, as of the sponsor's last update on 25 Apr 2013. 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 Austria. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: the only reason is that recruitment was not sufficient to meet the planned patient numbers, because complete remissions are still infrequent.). Results are not available in the source record.
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?
disease-free interval (time frame: 42 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 25 Apr 2013.