Melanoma (Skin)Phase 1NCT00658892
Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma
A Phase 1 study testing B7-DC cross-linking antibody rHIgM12B7, flow cytometry and immunologic technique in people with Melanoma (Skin), run by Mayo Clinic at 1 site in United States.
Trial summary
RATIONALE: Monoclonal antibodies can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- B7-DC cross-linking antibody rHIgM12B7, flow cytometry and immunologic technique
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2008to 22 May 2012
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed melanoma
- Stage IV disease (M1a and M1b only)
- Measurable disease according to RECIST criteria
- HLA-A2 positive
- Must have IgA in serum (any concentration)
- No known standard therapy for this disease that is potentially curative or proven capable of extending life expectancy
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Hemoglobin ≥ 10.0 g/dL
- Platelet count ≥ 75,000/mm^3
- AST ≤ 5 times upper limit of normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to provide informed consent
- Agrees to return to Mayo Clinic Rochester for follow-up
- Agrees to participate in the mandatory translational research component of the study
- No uncontrolled or current infection
- No known immune deficiency
- No B or AB blood grouping
PRIOR CONCURRENT THERAPY:
- More than 4 weeks since prior chemotherapy and recovered
- More than 4 weeks since prior biologic therapy
- No concurrent immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: B7-DC Xab Plasma Therapy for the Treatment of Metastatic Melanoma. A Feasibility/Pilot Study
RATIONALE: Monoclonal antibodies can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This clinical trial is studying the side effects and best dose of a monoclonal antibody in treating patients with stage IV melanoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the safety/toxicity of a single dose of B7-dendritic cell cross-linking antibody containing plasma in treating patients with stage IV melanoma.
Secondary
- Describe the immunological changes (Th1/Th2 balance, frequency of tumor specific cytotoxic T lymphocytes, and plasma cytokine profiles) in the treated patients.
- Determine the treatment impact on tumor growth (e.g., objective response, time to progression).
OUTLINE: Patients receive B7-dendritic cell cross-linking antibody IV once on day 1.
Patients undergo peripheral blood collection at baseline and periodically after infusion for analysis of dendritic cell activation, cytotoxic T-lymphocyte activity, immune cell impact, and serum cytokine changes using immunophenotyping and flow cytometry.
After completion of study treatment patients are followed every 2 months for 5 years.
- Conditions
- Melanoma (Skin)
- Being tested
- B7-DC cross-linking antibody rHIgM12B7, flow cytometry, immunologic technique, laboratory biomarker analysis
- Keywords
- recurrent melanoma, stage IV melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B7-DC cross-linking antibody rHIgM12B7Biological
flow cytometryOther
immunologic techniqueOther
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of B7-dendritic cell cross-linking antibody
Secondary outcomes (5)
Progression free survival and overall survival time
Toxicity
Tumor response in terms of complete or partial response at 8 weeks
Tetramer response
Percent change in the number of T, B, NK cells, monocytes and dendritic cells from pretreatment levels as well as the percent change in plasma concentrations of various molecular components
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2008 (estimated)
- Study start8 Apr 2008
- Primary completion15 Feb 2010
- Study completion22 May 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Svetomir Markovic, M.D., Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658892
- Sponsor's protocol ID
- CDR0000593085
- Other IDs
- P30CA015083, MC0677, 06-006992, NCI-2009-01343
- Status last verified
- May 2017
- First submitted
- 12 Apr 2008
- Last updated
- 25 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B7-DC Xab Plasma Therapy for the Treatment of Metastatic Melanoma. A Feasibility/Pilot Study
- ClinicalTrials.gov ID
- NCT00658892
- Acronym / sponsor ID
- CDR0000593085
- Conditions
- Melanoma (Skin)
- Keywords
- recurrent melanoma, stage IV melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Apr 2008 (actual)
- Primary completion
- 15 Feb 2010 (actual)
- Study completion
- 22 May 2012 (actual)
- First posted
- 15 Apr 2008 (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.
RATIONALE: Monoclonal antibodies can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This clinical trial is studying the side effects and best dose of a monoclonal antibody in treating patients with stage IV melanoma.
Detailed description
OBJECTIVES:
Primary
- Determine the safety/toxicity of a single dose of B7-dendritic cell cross-linking antibody containing plasma in treating patients with stage IV melanoma.
Secondary
- Describe the immunological changes (Th1/Th2 balance, frequency of tumor specific cytotoxic T lymphocytes, and plasma cytokine profiles) in the treated patients.
- Determine the treatment impact on tumor growth (e.g., objective response, time to progression).
OUTLINE: Patients receive B7-dendritic cell cross-linking antibody IV once on day 1.
Patients undergo peripheral blood collection at baseline and periodically after infusion for analysis of dendritic cell activation, cytotoxic T-lymphocyte activity, immune cell impact, and serum cytokine changes using immunophenotyping and flow cytometry.
After completion of study treatment patients are followed every 2 months for 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| B7-DC cross-linking antibody rHIgM12B7 | Biological | – |
| flow cytometry | Other | – |
| immunologic technique | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Maximum tolerated dose of B7-dendritic cell cross-linking antibody
5 secondary outcomes
Progression free survival and overall survival time
Toxicity
Tumor response in terms of complete or partial response at 8 weeks
Tetramer response
Percent change in the number of T, B, NK cells, monocytes and dendritic cells from pretreatment levels as well as the percent change in plasma concentrations of various molecular components
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
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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.
Svetomir Markovic, M.D., Ph.D. principal investigator
Mayo Clinic
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 B7-DC cross-linking antibody rHIgM12B7, flow cytometry and immunologic technique in people with Melanoma (Skin), run by Mayo Clinic at 1 site 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?
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 May 2017. 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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum tolerated dose of B7-dendritic cell cross-linking antibody. 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 May 2017.