Renal Cell CarcinomaPhase 1/2NCT00087984
RNA-Loaded Dendritic Cell Cancer Vaccine
A Phase 1/2 study testing MB-002 in people with Renal Cell Carcinoma, run by Argos Therapeutics at 5 sites in 2 countries.
Trial summary
The purpose of this trial is to examine the safety, feasibility, immunological response, and clinical antitumor activity of administering a dendritic cell vaccine to patients with metastatic renal cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- MB-002
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jan 2004to Sep 2008
- 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
- Have a new diagnosis of metastatic renal cell carcinoma;
- Must be at least 18 years or older;
- Have a scheduled unilateral nephrectomy;
- ECOG of 0 or 1;
- Free of brain metastases by CT or MRI;
- Normal renal function in contralateral kidney;
Show all 10Show fewer
- Male or non-pregnant/non-lactating female on appropriate birth control methods while on study;
- Clinically acceptable screening results.
- No immunosuppressive therapy not limited to corticosteroids (including topical steroids or steroid containing inhalers), azathioprine cyclosporine two months prior to study entry;
- No active autoimmune disease
Who cannot join
None listed.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States3 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
University of California - Irvine
Orange, California, 92868
Canada2 sites
Jewish General Hospital
Montreal, Quebec
Princess Margaret Hospital
Toronto, Ontario
About this study
Official title: A Phase I/II Study To Examine The Safety, Feasibility, Immunological Response, And Measures Of Clinical Antitumor Activity After Administering Unselected, Autologous, Amplified Tumor Total RNA-Transfected, Dendritic Cell Vaccine (MB-002) To Patients With Metastatic Renal Cell Carcinoma
The purpose of this trial is to examine the safety, feasibility, immunological response, and clinical antitumor activity of administering a dendritic cell vaccine to patients with metastatic renal cell carcinoma.
- Conditions
- Renal Cell Carcinoma
- Being tested
- MB-002
- Keywords
- Kidney cancer, Renal cancer
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MB-002Biological
Dendritic Cell Immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| MB-002-003 | Experimental | Not described Receives: Biological: MB-002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the safety of multiple administrations of MB-002 in patients with newly diagnosed, metastatic renal cell carcinoma.
Measured: From registration until disease progression or withdrawal from study
To measure clinical antitumor activity including objective tumor response and an estimate of time to tumor progression (or progression-free interval).
Measured: From registration until disease progression or withdrawal from study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2004 (estimated)
- Study startJan 2004
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Argos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00087984
- Sponsor's protocol ID
- MB-002-003
- Status last verified
- Feb 2013
- First submitted
- 16 Jul 2004
- Last updated
- 18 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study To Examine The Safety, Feasibility, Immunological Response, And Measures Of Clinical Antitumor Activity After Administering Unselected, Autologous, Amplified Tumor Total RNA-Transfected, Dendritic Cell Vaccine (MB-002) To Patients With Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00087984
- Acronym / sponsor ID
- MB-002-003
- Conditions
- Renal Cell Carcinoma
- Keywords
- Kidney cancer, Renal cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Argos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 20 Jul 2004 (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 trial is to examine the safety, feasibility, immunological response, and clinical antitumor activity of administering a dendritic cell vaccine to patients with metastatic renal cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MB-002-003 | Experimental | Biological: MB-002 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Have a new diagnosis of metastatic renal cell carcinoma;
- Must be at least 18 years or older;
- Have a scheduled unilateral nephrectomy;
- ECOG of 0 or 1;
- Free of brain metastases by CT or MRI;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| MB-002Dendritic Cell Immunotherapy | Biological | MB-002-003 |
Primary outcome
To examine the safety of multiple administrations of MB-002 in patients with newly diagnosed, metastatic renal cell carcinoma.
Time frame: From registration until disease progression or withdrawal from study
To measure clinical antitumor activity including objective tumor response and an estimate of time to tumor progression (or progression-free interval).
Time frame: From registration until disease progression or withdrawal from study
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 18 Feb 2013.
- Kidney Cancer AssociationLink provided by the sponsor.
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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
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Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
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Localized Clear Cell Renal Cell Carcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MB-002 in people with Renal Cell Carcinoma, run by Argos Therapeutics at 5 sites in 2 countries.
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 10 inclusion and 0 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 18 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. 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?
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?
To examine the safety of multiple administrations of MB-002 in patients with newly diagnosed, metastatic renal cell carcinoma. (time frame: From registration until disease progression or withdrawal from study). The study lists 2 primary outcomes in all. 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 18 Feb 2013.