Metastatic MelanomaPhase 1NCT01216436
Local Modulation of Immune Receptors to Enhance the Response to Dendritic Cell Vaccination in Metastatic Melanoma
A Phase 1 study testing Vaccination with RNA-transfected mature autologous DC in people with Metastatic Melanoma, run by Duke University at 1 site in United States.
Trial summary
Our proposed study is designed to test the safety of a new vaccine against melanoma. The induction of immune activity against cancers such as melanoma is a promising approach to cancer treatment, but to date, only a few clinically significant immune responses have been seen following vaccine therapy. 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?
- Vaccination with RNA-transfected mature autologous DC
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Oct 2013
- 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
- Patients with confirmed metastatic melanoma
- Karnofsky performance status greater than or equal to 70%.
- Estimated life expectancy > 6 months.
- Age > 17 years.
- Adequate hematologic function with:
- WBC >= 3000 mm3
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- hemoglobin >= 9 mg/dl
- platelets >= 100,000/mm3
- Adequate renal and hepatic function with:
- serum creatinine < 2.5 mg/dl
- bilirubin < 2.0 mg/dl
- AST/SGOT < 70 U/L
- ALT/SGPT < 70 U/L
- Alkaline Phosphatase ≤ 135 U/L
- Ability to understand and provide signed informed consent that fulfills Institutional Review Board guidelines.
- Ability to return to Duke University Medical Center for adequate follow-up as required by this protocol.
Who cannot join
- Subjects undergoing concurrent chemotherapy, radiation therapy, or immunotherapy will be excluded.
- The subject has previously irradiated, surgically treated, or newly diagnosed central nervous system (CNS) metastases will be excluded (Pre-enrollment head CT is not required if not indicated by clinical signs or symptoms).
- Subjects with a history of autoimmune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis will be excluded.
- Subjects with serious concurrent chronic or acute illness such as pulmonary (asthma or COPD), cardiac (NYHA class III or IV) or hepatic disease, or other illness considered by the principal investigator to constitute an unwarranted high risk for investigational drug administration will be excluded.
- Subjects with medical or psychological impediment to probable compliance with the protocol will be excluded.
- Subjects with concurrent second malignancy other than melanoma or non-melanoma skin cancer will be excluded. In the event of prior non-melanoma malignancies treated surgically, the subject must be considered NED (no evidence of disease) for a minimum of 3 years prior to enrollment.
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- Presence of an active acute or chronic infection, including symptomatic urinary tract infection, HIV (as determined by ELISA and confirmed by Western Blot) or viral hepatitis (as determined by HBsAg and Hepatitis C serology) will lead to subject exclusion.
- Subjects receiving steroid therapy (or other immunosuppressive agents such as azathioprine or cyclosporine A) are excluded on the basis of potential immune suppression.
- Subjects with inadequate peripheral vein access to undergo leukapheresis will be excluded.
- Female subjects with a positive pregnancy test, as well as those who have not previously undergone hysterectomy and/or bilateral oophorectomy and are unwilling to utilize a medically approved form of contraception, from the time of enrollment until 6 weeks after the final immunization, will be excluded.
- Male subjects, not previously surgically sterilized, who are unwilling to use a condom with spermicide during any sexual activity occurring over the entire immunization period and for the 6 weeks that immediately follow the final immunization will be excluded.
- Subjects with a documented history of severe allergic reaction to beta-lactams, eggs or soy products.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Phase 1 Study of Local Modulation of Immune Receptor Function to Enhance Immune Responses to Dendritic Cell Vaccination in Subjects With Metastatic Melanoma
Our proposed study is designed to test the safety of a new vaccine against melanoma. The induction of immune activity against cancers such as melanoma is a promising approach to cancer treatment, but to date, only a few clinically significant immune responses have been seen following vaccine therapy. This is an important problem, since there are very limited treatment options for patients with metastatic melanoma (melanoma that has spread to lymph nodes and organs).
Studies suggest that monoclonal antibodies (mAbs) that block inhibitory receptors on immune cells can enhance the immune responses against cancer, but the intravenous injection of such mAbs has caused severe side effects in animals and humans. In our laboratory, we have developed a method to deliver mAbs and other proteins that block such inhibitory receptors locally at the site where immune responses against melanoma proteins are stimulated by vaccination, enhancing anti-melanoma immunity while avoiding the side-effects associated with intravenous injection of these immune modulators. This is achieved by loading dendritic cells, a type of immune cell, with RNA that encodes the immune modulator. The RNA-loaded dendritic cells then make the immune modulatory proteins and release them locally. By mixing these dendritic cells with additional dendritic cells loaded with melanoma proteins, the immune modulators are released at the site where anti-melanoma immune cells are stimulated.
In this phase I trial, subjects with metastatic melanoma will undergo the process of leukapheresis, in which white blood cells are removed from the body. Monocytes, a type of immune cell, will then be purified from the white blood cells and cultured under conditions that will change them into dendritic cells. Half of these dendritic cells are then loaded with melanoma antigen RNA, which will lead to the production of melanoma antigen proteins within the dendritic cells. The remaining half of the dendritic cells will be either untreated or loaded with RNA encoding immune modulators so that these dendritic cells will release immune modulators at the site of vaccination. These dendritic cells will be mixed with the melanoma antigen-loaded dendritic cells and injected as a vaccine into lymph nodes. Each subject will receive six weekly injections of their own dendritic cells. Safety and toxicity will be closely monitored. In addition, immune responses against melanoma, as well as clinical responses, will be assessed.
Read the detailed description
A variety of trials of immunotherapy in metastatic melanoma have clearly demonstrated that immune responses against melanoma can be induced, but only a few patient have responded clinically, suggesting that new strategies to enhance anti-cancer immune responses are needed. Most of these immunotherapy trials have focused on antigen delivery and providing stimulatory antigen-specific signals to T cells. However, the induction of antigen-specific T cell-mediated immune responses is regulated not only by stimulatory signals, but also by inhibitory receptor-mediated signals. Studies have demonstrated that administering mAbs targeting such immune-modulating receptors on T cells enhances vaccine-induced anti-tumor immunity, suggesting that such an approach might improve the efficacy of clinical cancer vaccines. However, systemic administration such mAbs has been associated with severe, sometimes fatal, autoimmunity. We have developed an approach for targeted delivery of such immune modulatory proteins and mAbs, using immune modulator RNA-transfected dendritic cells (DC), to sites where anti-tumor T cells are induced. Our preliminary studies indicate that this approach may eliminate the adverse effects associated with systemic administration immune modulators, while also enhancing vaccine-induced immune responses.
Therefore, the objective of this proposed Phase I immunotherapy trial is to determine the safety and obtain preliminary data on the efficacy of vaccination of human subjects with melanoma tumor associated antigen (TAA) RNA-transfected mature monocyte-derived DC coadministered with additional untransfected DC (Study Arm A), DC transfected with RNA encoding a soluble GITR-L fusion protein (Study Arm B), DC transfected with RNA encoding the humanized heavy and light chains of an antagonistic anti-CTLA-4 mAb (Study Arm C), or DC transfected with combined GITR-L and anti-CTLA-4 mAb RNA (Study Arm D). All study subjects will undergo leukapheresis for collection of peripheral blood mononuclear cells (PBMC) and purified monocytes will be cultured with the cytokines GM-CSF and IL-4 to produce immature DC. After the induction maturation with a standard cytokine cocktail, half of the DC will then be transfected with RNA encoding melanoma TAAs MART, tyrosinase, and gp100, and MAGE-3, while the remaining half of the DC will be either untransfected (Study Arm A) or will be transfected with immune modulator RNA (Study Arm B, C, and D). DC will be cryopreserved. Subjects will then be immunized with these DC, weekly for six intranodal injections. For each subject, safety and toxicity will be assessed, and anti-tumor immune responses will be measured.
- Conditions
- Metastatic Melanoma
- Being tested
- Vaccination with RNA-transfected mature autologous DC
- Keywords
- melanoma, immunotherapy, dendritic cell, GITR-ligand, CTLA-4
- Medical subject headings
- Melanoma, Diabetes Mellitus, Insulin-Dependent, 12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccination with RNA-transfected mature autologous DCBiological
Dendritic cells (DC) will be administered at a dose of 20 million cells by intranodal injection under ultrasound guidance. Each subject will receive a total of six vaccinations at one week intervals
| Study group | Role | What they receive |
|---|---|---|
| Vaccine plus untransfected DC | Experimental | Subjects in all study arms will be vaccinated with mature autologous dendritic cells transfected with a combination of RNAs encoding melanoma tumor associated antigens MART, Tyrosinase, gp100, and MAGE-3. In this Study Arm (Study Arm A), each subject will be coinjected with additional mature autologous dendritic cells that are not transfected with RNA. Receives: Biological: Vaccination with RNA-transfected mature autologous DC |
| Vaccine plus GITRL RNA DC | Experimental | Subjects in all study arms will be vaccinated with mature autologous dendritic cells transfected with a combination of RNAs encoding melanoma tumor associated antigens MART, Tyrosinase, gp100, and MAGE-3. In this Study Arm (Study Arm B), each subject will be coinjected with additional mature autologous dendritic cells transfected with RNA encoding the immune modulator GITR-L. Receives: Biological: Vaccination with RNA-transfected mature autologous DC |
| Vaccine plus antiCTLA4 RNA DC | Experimental | Subjects in all study arms will be vaccinated with mature autologous dendritic cells transfected with a combination of RNAs encoding melanoma tumor associated antigens MART, Tyrosinase, gp100, and MAGE-3. In this Study Arm (Study Arm C), each subject will be coinjected with additional mature autologous dendritic cells transfected with RNA encoding immune modulator anti-CTLA4 mAb. Receives: Biological: Vaccination with RNA-transfected mature autologous DC |
| Vaccine plus GITRL/ antiCTLA4 RNA DC | Experimental | Subjects in all study arms will be vaccinated with mature autologous dendritic cells transfected with a combination of RNAs encoding melanoma tumor associated antigens MART, Tyrosinase, gp100, and MAGE-3. In this Study Arm (Study Arm D), each subject will be coinjected with additional mature autologous dendritic cells transfected with RNA encoding both GITR-L and anti-CTLA4 mAb immune modulators. Receives: Biological: Vaccination with RNA-transfected mature autologous DC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Safety and Tolerability will be assessed for all subjects during the vaccination period and then regularly during the post-vaccination period. All subjects will then be followed clinically as would be done any subject with melanoma for a total of 5 years.
Measured: A minimum of 6 months
Secondary outcomes (1)
Cellular anti-melanoma immune responses will be assessed
T cells from blood collected after each vaccination and following the full course of vaccination will be assessed for melanoma antigen-specificity using Interferon-gamma Elispot and cytotoxicity assays. Immune responses will be assessed following each vaccination and then will continue to be assessed until anti-melanoma immune responses return to baseline levels.
Measured: A minimum of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startJan 2010
- Primary completionOct 2013
- Study completionOct 2013
Why it stopped: The PI retired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott K Pruitt, MD, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216436
- Sponsor's protocol ID
- Pro00019239
- Status last verified
- Apr 2014
- First submitted
- 1 Feb 2010
- Last updated
- 25 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Pruitt SK, Boczkowski D, de Rosa N, Haley NR, Morse MA, Tyler DS, Dannull J, Nair S. Enhancement of anti-tumor immunity through local modulation of CTLA-4 and GITR by dendritic cells. Eur J Immunol. 2011 Dec;41(12):3553-63. doi: 10.1002/eji.201141383. Epub 2011 Oct 26.
PubMed 22028176Boczkowski D, Lee J, Pruitt S, Nair S. Dendritic cells engineered to secrete anti-GITR antibodies are effective adjuvants to dendritic cell-based immunotherapy. Cancer Gene Ther. 2009 Dec;16(12):900-11. doi: 10.1038/cgt.2009.39. Epub 2009 Jun 5.
PubMed 19498460
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Local Modulation of Immune Receptor Function to Enhance Immune Responses to Dendritic Cell Vaccination in Subjects With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT01216436
- Acronym / sponsor ID
- Pro00019239
- Conditions
- Metastatic Melanoma
- Keywords
- melanoma, immunotherapy, dendritic cell, GITR-ligand, CTLA-4
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The PI retired
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 7 Oct 2010 (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.
Our proposed study is designed to test the safety of a new vaccine against melanoma. The induction of immune activity against cancers such as melanoma is a promising approach to cancer treatment, but to date, only a few clinically significant immune responses have been seen following vaccine therapy. This is an important problem, since there are very limited treatment options for patients with metastatic melanoma (melanoma that has spread to lymph nodes and organs).
Studies suggest that monoclonal antibodies (mAbs) that block inhibitory receptors on immune cells can enhance the immune responses against cancer, but the intravenous injection of such mAbs has caused severe side effects in animals and humans. In our laboratory, we have developed a method to deliver mAbs and other proteins that block such inhibitory receptors locally at the site where immune responses against melanoma proteins are stimulated by vaccination, enhancing anti-melanoma immunity while avoiding the side-effects associated with intravenous injection of these immune modulators. This is achieved by loading dendritic cells, a type of immune cell, with RNA that encodes the immune modulator. The RNA-loaded dendritic cells then make the immune modulatory proteins and release them locally. By mixing these dendritic cells with additional dendritic cells loaded with melanoma proteins, the immune modulators are released at the site where anti-melanoma immune cells are stimulated.
In this phase I trial, subjects with metastatic melanoma will undergo the process of leukapheresis, in which white blood cells are removed from the body. Monocytes, a type of immune cell, will then be purified from the white blood cells and cultured under conditions that will change them into dendritic cells. Half of these dendritic cells are then loaded with melanoma antigen RNA, which will lead to the production of melanoma antigen proteins within the dendritic cells. The remaining half of the dendritic cells will be either untreated or loaded with RNA encoding immune modulators so that these dendritic cells will release immune modulators at the site of vaccination. These dendritic cells will be mixed with the melanoma antigen-loaded dendritic cells and injected as a vaccine into lymph nodes. Each subject will receive six weekly injections of their own dendritic cells. Safety and toxicity will be closely monitored. In addition, immune responses against melanoma, as well as clinical responses, will be assessed.
Detailed description
A variety of trials of immunotherapy in metastatic melanoma have clearly demonstrated that immune responses against melanoma can be induced, but only a few patient have responded clinically, suggesting that new strategies to enhance anti-cancer immune responses are needed. Most of these immunotherapy trials have focused on antigen delivery and providing stimulatory antigen-specific signals to T cells. However, the induction of antigen-specific T cell-mediated immune responses is regulated not only by stimulatory signals, but also by inhibitory receptor-mediated signals. Studies have demonstrated that administering mAbs targeting such immune-modulating receptors on T cells enhances vaccine-induced anti-tumor immunity, suggesting that such an approach might improve the efficacy of clinical cancer vaccines. However, systemic administration such mAbs has been associated with severe, sometimes fatal, autoimmunity. We have developed an approach for targeted delivery of such immune modulatory proteins and mAbs, using immune modulator RNA-transfected dendritic cells (DC), to sites where anti-tumor T cells are induced. Our preliminary studies indicate that this approach may eliminate the adverse effects associated with systemic administration immune modulators, while also enhancing vaccine-induced immune responses.
Therefore, the objective of this proposed Phase I immunotherapy trial is to determine the safety and obtain preliminary data on the efficacy of vaccination of human subjects with melanoma tumor associated antigen (TAA) RNA-transfected mature monocyte-derived DC coadministered with additional untransfected DC (Study Arm A), DC transfected with RNA encoding a soluble GITR-L fusion protein (Study Arm B), DC transfected with RNA encoding the humanized heavy and light chains of an antagonistic anti-CTLA-4 mAb (Study Arm C), or DC transfected with combined GITR-L and anti-CTLA-4 mAb RNA (Study Arm D). All study subjects will undergo leukapheresis for collection of peripheral blood mononuclear cells (PBMC) and purified monocytes will be cultured with the cytokines GM-CSF and IL-4 to produce immature DC. After the induction maturation with a standard cytokine cocktail, half of the DC will then be transfected with RNA encoding melanoma TAAs MART, tyrosinase, and gp100, and MAGE-3, while the remaining half of the DC will be either untransfected (Study Arm A) or will be transfected with immune modulator RNA (Study Arm B, C, and D). DC will be cryopreserved. Subjects will then be immunized with these DC, weekly for six intranodal injections. For each subject, safety and toxicity will be assessed, and anti-tumor immune responses will be measured.
Study design
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vaccine plus untransfected DC | Experimental | Biological: Vaccination with RNA-transfected mature autologous DCSubjects in all study arms will be vaccinated with mature autologous dendritic cells transfected with a combination of RNAs encoding melanoma tumor associated antigens MART, Tyrosinase, gp100, and MAGE-3. In this Study Arm (Study Arm A), each subject will be coinjected with additional mature autologous dendritic cells that are not transfected with RNA. |
| Vaccine plus GITRL RNA DC | Experimental | Biological: Vaccination with RNA-transfected mature autologous DCSubjects in all study arms will be vaccinated with mature autologous dendritic cells transfected with a combination of RNAs encoding melanoma tumor associated antigens MART, Tyrosinase, gp100, and MAGE-3. In this Study Arm (Study Arm B), each subject will be coinjected with additional mature autologous dendritic cells transfected with RNA encoding the immune modulator GITR-L. |
| Vaccine plus antiCTLA4 RNA DC | Experimental | Biological: Vaccination with RNA-transfected mature autologous DCSubjects in all study arms will be vaccinated with mature autologous dendritic cells transfected with a combination of RNAs encoding melanoma tumor associated antigens MART, Tyrosinase, gp100, and MAGE-3. In this Study Arm (Study Arm C), each subject will be coinjected with additional mature autologous dendritic cells transfected with RNA encoding immune modulator anti-CTLA4 mAb. |
| Vaccine plus GITRL/ antiCTLA4 RNA DC | Experimental | Biological: Vaccination with RNA-transfected mature autologous DCSubjects in all study arms will be vaccinated with mature autologous dendritic cells transfected with a combination of RNAs encoding melanoma tumor associated antigens MART, Tyrosinase, gp100, and MAGE-3. In this Study Arm (Study Arm D), each subject will be coinjected with additional mature autologous dendritic cells transfected with RNA encoding both GITR-L and anti-CTLA4 mAb immune modulators. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients with confirmed metastatic melanoma
- Karnofsky performance status greater than or equal to 70%.
- Estimated life expectancy > 6 months.
- Age > 17 years.
- Adequate hematologic function with:
Key exclusion criteria (12 listed)
- Subjects undergoing concurrent chemotherapy, radiation therapy, or immunotherapy will be excluded.
- The subject has previously irradiated, surgically treated, or newly diagnosed central nervous system (CNS) metastases will be excluded (Pre-enrollment head CT is not required if not indicated by clinical signs or symptoms).
- Subjects with a history of autoimmune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis will be excluded.
- Subjects with serious concurrent chronic or acute illness such as pulmonary (asthma or COPD), cardiac (NYHA class III or IV) or hepatic disease, or other illness considered by the principal investigator to constitute an unwarranted high risk for investigational drug administration will be excluded.
- Subjects with medical or psychological impediment to probable compliance with the protocol will be excluded.
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 |
|---|---|---|
| Vaccination with RNA-transfected mature autologous DCDendritic cells (DC) will be administered at a dose of 20 million cells by intranodal injection under ultrasound guidance. Each subject will receive a total of six vaccinations at one week intervals | Biological | Vaccine plus GITRL RNA DC, Vaccine plus GITRL/ antiCTLA4 RNA DC, Vaccine plus antiCTLA4 RNA DC, Vaccine plus untransfected DC |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: A minimum of 6 months
Safety and Tolerability will be assessed for all subjects during the vaccination period and then regularly during the post-vaccination period. All subjects will then be followed clinically as would be done any subject with melanoma for a total of 5 years.
1 secondary outcome
Cellular anti-melanoma immune responses will be assessed
Time frame: A minimum of 4 months
Results and safety
The study was stopped early (reason given: The PI retired). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2015.
- Background: PubMed 22028176Pruitt SK, Boczkowski D, de Rosa N, Haley NR, Morse MA, Tyler DS, Dannull J, Nair S. Enhancement of anti-tumor immunity through local modulation of CTLA-4 and GITR by dendritic cells. Eur J Immunol. 2011 Dec;41(12):3553-63. doi: 10.1002/eji.201141383. Epub 2011 Oct 26.
- Background: PubMed 19498460Boczkowski D, Lee J, Pruitt S, Nair S. Dendritic cells engineered to secrete anti-GITR antibodies are effective adjuvants to dendritic cell-based immunotherapy. Cancer Gene Ther. 2009 Dec;16(12):900-11. doi: 10.1038/cgt.2009.39. Epub 2009 Jun 5.
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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.
Scott K Pruitt, MD, PhD principal investigator
Duke University
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 Vaccination with RNA-transfected mature autologous DC in people with Metastatic Melanoma, run by Duke University 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?
The sponsor lists 16 inclusion and 12 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 May 2015. 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 was stopped early (reason given: The PI retired). 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?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: A minimum of 6 months). 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 NCT01216436, 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 May 2015.