MelanomaPhase 1/2NCT00125749
Vaccination of Patients With Stage IV Melanoma With Dendritic Cells
A Phase 1/2 study testing Dendritic cell vaccination in people with Melanoma and Neoplasm Metastasis, run by Baylor Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to test a novel dendritic cell (DC) vaccine in patients with Stage IV melanoma. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Melanoma, Neoplasm Metastasis
- What is being tested?
- Dendritic cell vaccination
- Type of treatment
- Vaccines
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Jun 2007
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage M1a, M1b, M1c biopsy proven metastatic melanoma
- Failure of at least one prior chemotherapy regimen of DTIC and/or temozolomide with/without interleukin-2 (IL-2).
- Karnofsky performance status greater than/equal to 80%.
- Measurable metastatic lesions by physical exam or scans.
- Acceptable CBC and blood chemistry results
- Adequate renal function.
- Written informed consent.
Who cannot join
- Patients who have received more than 8 cycles of chemotherapy for metastatic melanoma.
- Patients who have received chemotherapy less than 4 weeks before beginning the trial.
- Patients who have received interferon (IFN) alpha-2b or granulocyte-monocyte colony-stimulating factor (GM-CSF) less than 4 weeks before beginning the trial.
- Patients who have received high-dose IL-2 less than 4 weeks before beginning the trial.
- Patients with a history of central nervous system (CNS) metastatic melanoma.
- More than 5 hepatic lesions or any hepatic lesion larger than 5 cm.
Show all 14Show fewer
- Baseline serum LDH greater than 4 times the upper limit of normal.
- Patients who are HIV positive.
- Patients who are pregnant.
- Patients who have received corticosteroids or other agents less than 4 weeks before beginning the trial.
- Patients with asthma, angina pectoris or congestive heart failure.
- Patients with autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis.
- Patients with active infections including viral hepatitis.
- Patients with a history of any other neoplastic disease less than 5 years ago (carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin, however, can be admitted to the study).
Trial locations and contacts
1 site in 1 country.
United States1 site
Mary Crowley Medical Research Center: Baylor University Medical Center
Dallas, Texas, 75246
About this study
Official title: Vaccination of Patients With Stage IV Melanoma With Dendritic Cells Generated Ex Vivo From Monocytes and Loaded With Heat Treated Killed Allogeneic Melanoma Cells
The purpose of this study is to test a novel dendritic cell (DC) vaccine in patients with Stage IV melanoma.
Read the detailed description
A novel dendritic cell vaccine has been developed at the Baylor Institute for Immunology Research (BIIR). Pre-clinical studies have found that this dendritic cell vaccine is more efficient in inducing a tumor specific immunity than other dendritic cell vaccines. Further studies in the BIIR have been done with dendritic cells that were loaded with killed melanoma cells from a melanoma cell line treated with heat before loading. Both studies have shown that DCs manufactured in this novel way were more efficient in priming the melanoma specific CD8+ cells. Thus, the strategy for this clinical trial will be to test recent laboratory findings in the clinical setting. An additional objective of the study will be to determine the effectiveness of a frozen vaccine product which differs from previous vaccines that were manufactured "fresh".
This clinical trial will evaluate the novel dendritic cell vaccine in patients with Stage IV melanoma. The trial will accrue a total of 30 subjects. The primary goal of this trial will be to test the safety/tolerability/feasibility of the vaccine preparation and the rate of objective clinical response. A 15% objective response rate will be accepted in patients who have failed previous therapy with IL-2 and/or dacarbazine (DTIC) and/or temozolomide which are standard treatments for patients with malignant melanoma.
Each subject will be given 7 initial injections in a fixed dose amount. The first 4 doses will be given at 2-week intervals (Weeks 0, 2, 4 and 6); the last 3 doses will be given at 4-week intervals (Weeks 10, 14, and 18). Those patients who exhibit stable disease, partial response or complete response after 7 injections will be given 4 more vaccinations. Each of these additional 4 vaccinations will be given 3 months apart (Weeks 36, 48, 72 and 96). Scans and re-staging tests will be performed at scheduled intervals throughout the study.
- Conditions
- Melanoma, Neoplasm Metastasis
- Being tested
- Dendritic cell vaccination
- Keywords
- Dendritic, Vaccine, Melanoma, Stage IV metastatic melanoma
- 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.
Dendritic cell vaccinationBiological
Autologous Dendritic Cells Derived from PBMC, Cultured with Cytokines, Pulsed Ex Vivo with Irradiated Allogeneic (Colo 829) Melanoma Cells
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of the novel DC vaccination product in human subjects
Measured: 3 years
Feasibility of a novel approach to DC manufacture
Measured: 3 years
Objective clinical responses
Measured: 3 years
Secondary outcomes (1)
Immunogenicity of frozen DC vaccinations
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2005 (estimated)
- Study startJul 2005
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Mary Crowley Medical Research Center, ODC Therapy
- Responsible party
- Sponsor
- Investigators
- Anna Karolina Palucka, MD, PhD, Study director, Baylor Institute for Immunology Research: Baylor University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125749
- Sponsor's protocol ID
- 005-065-02
- Status last verified
- Jun 2017
- First submitted
- 1 Aug 2005
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccination of Patients With Stage IV Melanoma With Dendritic Cells Generated Ex Vivo From Monocytes and Loaded With Heat Treated Killed Allogeneic Melanoma Cells
- ClinicalTrials.gov ID
- NCT00125749
- Acronym / sponsor ID
- 005-065-02
- Conditions
- Melanoma, Neoplasm Metastasis
- Keywords
- Dendritic, Vaccine, Melanoma, Stage IV metastatic melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Collaborators
- Mary Crowley Medical Research Center, ODC Therapy
- Study start
- Jul 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 2 Aug 2005 (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 test a novel dendritic cell (DC) vaccine in patients with Stage IV melanoma.
Detailed description
A novel dendritic cell vaccine has been developed at the Baylor Institute for Immunology Research (BIIR). Pre-clinical studies have found that this dendritic cell vaccine is more efficient in inducing a tumor specific immunity than other dendritic cell vaccines. Further studies in the BIIR have been done with dendritic cells that were loaded with killed melanoma cells from a melanoma cell line treated with heat before loading. Both studies have shown that DCs manufactured in this novel way were more efficient in priming the melanoma specific CD8+ cells. Thus, the strategy for this clinical trial will be to test recent laboratory findings in the clinical setting. An additional objective of the study will be to determine the effectiveness of a frozen vaccine product which differs from previous vaccines that were manufactured "fresh".
This clinical trial will evaluate the novel dendritic cell vaccine in patients with Stage IV melanoma. The trial will accrue a total of 30 subjects. The primary goal of this trial will be to test the safety/tolerability/feasibility of the vaccine preparation and the rate of objective clinical response. A 15% objective response rate will be accepted in patients who have failed previous therapy with IL-2 and/or dacarbazine (DTIC) and/or temozolomide which are standard treatments for patients with malignant melanoma.
Each subject will be given 7 initial injections in a fixed dose amount. The first 4 doses will be given at 2-week intervals (Weeks 0, 2, 4 and 6); the last 3 doses will be given at 4-week intervals (Weeks 10, 14, and 18). Those patients who exhibit stable disease, partial response or complete response after 7 injections will be given 4 more vaccinations. Each of these additional 4 vaccinations will be given 3 months apart (Weeks 36, 48, 72 and 96). Scans and re-staging tests will be performed at scheduled intervals throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Stage M1a, M1b, M1c biopsy proven metastatic melanoma
- Failure of at least one prior chemotherapy regimen of DTIC and/or temozolomide with/without interleukin-2 (IL-2).
- Karnofsky performance status greater than/equal to 80%.
- Measurable metastatic lesions by physical exam or scans.
- Acceptable CBC and blood chemistry results
Key exclusion criteria (14 listed)
- Patients who have received more than 8 cycles of chemotherapy for metastatic melanoma.
- Patients who have received chemotherapy less than 4 weeks before beginning the trial.
- Patients who have received interferon (IFN) alpha-2b or granulocyte-monocyte colony-stimulating factor (GM-CSF) less than 4 weeks before beginning the trial.
- Patients who have received high-dose IL-2 less than 4 weeks before beginning the trial.
- Patients with a history of central nervous system (CNS) metastatic melanoma.
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 |
|---|---|---|
| Dendritic cell vaccinationAutologous Dendritic Cells Derived from PBMC, Cultured with Cytokines, Pulsed Ex Vivo with Irradiated Allogeneic (Colo 829) Melanoma Cells | Biological | – |
Primary outcome
Safety and tolerability of the novel DC vaccination product in human subjects
Time frame: 3 years
Feasibility of a novel approach to DC manufacture
Time frame: 3 years
Objective clinical responses
Time frame: 3 years
1 secondary outcome
Immunogenicity of frozen DC vaccinations
Time frame: 3 years
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 12 Jun 2017.
- Click here for more information about this study.Link provided by the sponsor.
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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.
Anna Karolina Palucka, MD, PhD study director
Baylor Institute for Immunology Research: Baylor University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dendritic cell vaccination in people with Melanoma and Neoplasm Metastasis, run by Baylor Research Institute 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 7 inclusion and 14 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 12 Jun 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 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?
Safety and tolerability of the novel DC vaccination product in human subjects (time frame: 3 years). The study lists 3 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 12 Jun 2017.