MelanomaPhase 1NCT00700167
Immune Responses To Antigen-Bearing Dendritic Cells in Patients With Malignancy
A Phase 1 study testing dendritic cell vaccine in people with Melanoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
Cancer cells make proteins called antigens that act as markers for the tumor cells. These antigens cannot cause the cancer itself. Special white blood cells, called T cells or T lymphocytes, recognize and respond to antigens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- dendritic cell vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Apr 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
- Diagnosis of metastatic melanoma, AJCC stage III or IV, with histologic confirmation by Dept. of Pathology at MSKCC.
- Patients must be HLA-A*0201 positive.
- Expected survival of greater than 3 months.
- Karnofsky performance status 70 or better.
- Patients may not have received chemotherapy, immunotherapy, or radiation within approximately 4 weeks (approximately 6 weeks for nitrosoureas or mitomycin) before participation in this protocol.
- Patients should not be receiving immune modifying pharmacologics (e.g., interferon) for approximately 2-4 weeks before enrollment.
Who cannot join
- Pregnant (clinically documented or positive pregnancy test within approximately 2 wks of study entry) or lactating women, because immunization will include differentiation antigens shared by melanoma tumors and melanocytes, and immune responses to these differentiation antigens could have unknown developmental sequelae to a fetus or infant.
- Pregnancy tests are not required for post-menopausal women, and post-menopausal status by patient report should be documented accordingly.
- Patients requiring systemic corticosteroids or comparable exogenous immunosuppressive agent(s) (no exclusion for use of NSAIDs)
- Patients who have a known immunodeficiency (e.g., infection with HTLV-1,2, HIV-1,2; etc.) because of the T cell defects that would alter their responses and the investigators' ability to assess their outcomes accurately.
- Patients with preexisting retinal or choroidal eye disease.
- Patients with coexisting autoimmune diseases, except vitiligo.
Show all 12Show fewer
- Patients with significantly impaired hematologic, hepatic, or renal function, e.g., ANC <1000, hgb < 8.0 g/dl, plts < 50,000/ul, AST >3x ULN, creatinine >2.0 or Cl creat <30ml/min, all assessed within approximately two weeks of study entry.
- Patients with serious coexisting medical illness.
- Patients with organ allografts.
- Patients who are s/p splenectomy or s/p splenic irradiation.
- Patients with active brain metastases.
- Patients with organic brain syndrome or psychologic impairment that would preclude participation and compliance with this protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Immune Responses To Antigen-Bearing Dendritic Cells in Patients With Malignancy - A Phase I Trial in Melanoma
Cancer cells make proteins called antigens that act as markers for the tumor cells. These antigens cannot cause the cancer itself. Special white blood cells, called T cells or T lymphocytes, recognize and respond to antigens. In many diseases, these and other cells in the immune system help your body get rid of the disease. However, T cells are normally resting, and they need other proteins on the diseased cell surface to begin working. Unfortunately, cancer cells do not usually make all the other proteins that T cells need to work. Therefore, T cells do not normally work against the cancer cells. We think this is one of the reasons that cancers grow and are not rejected by the body in the first place.
Another white blood cell, called a dendritic cell, does have most if not all of the special proteins needed to make T cells work to destroy cancer cells. However, dendritic cells do not normally have the cancer proteins on their surface. The challenge then is to combine the cancer markers (antigens) with these dendritic cells to make a vaccine. We think that the body's T cells might then react against the tumor and help destroy it. This study will see if putting tumor antigens made in a lab onto dendritic cells will make T cells work against tumor cells. We want to answer this question by injecting you with dendritic cells loaded with the antigens. Then we will check for a response based on lab studies and your own clinical course. We will compare your response against melanoma with your response against a common antigen, to which almost everyone has already been exposed. Flu, for example, is a common antigen to which most people have been exposed. We also need to test your response to an antigen that your body has not likely seen before. For example, we plan to use KLH (keyhole limpet hemocyanin), which is a pigment or color protein made from a sea creature known as a keyhole limpet. Each of these, the flu and KLH antigens, which should be harmless to you, will be used along with the dendritic cell-tumor vaccine. This will help us find out if the vaccine is working, based on the lab studies we will check before and after the vaccinations.
- Conditions
- Melanoma
- Being tested
- dendritic cell vaccine
- Keywords
- ANTIGENBEARING DENDRITIC CELLS, 98-098
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dendritic cell vaccineBiological
The vaccine will be split between as many as 10 injections, more or less. Each shot will be about 1/25th to 1/50th of a teaspoon (100 to 200 microliters). Each vaccine will be injected with a tiny needle just under your skin. This will usually cause a very small area of swelling at the injection site that may last for a few minutes to an hour or so. You will receive two additional "booster" doses of the same vaccine every 4-6 weeks. This would mean that you receive a total of three vaccines over about 2-3 months.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | The vaccine will be split between as many as 10 injections, more or less. Each shot will be about 1/25th to 1/50th of a teaspoon (100 to 200 microliters). Each vaccine will be injected with a tiny needle just under your skin. This will usually cause a very small area of swelling at the injection site that may last for a few minutes to an hour or so. You will receive two additional "booster" doses of the same vaccine every 4-6 weeks. This would mean that you receive a total of three vaccines over about 2-3 months.
The vaccines will be given during an outpatient visit. If for some reason, you happen to be in the hospital, you can still receive the vaccines. These visits should take no longer than 15-30 minutes. Receives: Biological: dendritic cell vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate safety and toxicity of immunizations of patients with stage III/IV melanoma, using autologous DCs pulsed with antigenic peptides expressed by melanoma, together with class I MHC (influenza) and class II MHC (KLH) -restricted control antigens.
Measured: conclusion of the study
Evaluate further the immunogenicity of tumor antigen-bearing dendritic cells, based on the same in vitro assays as above, measured pre-& post-dendritic cell immunization with the optimal biologic dose of DCs selected in the phase Ia portion of the trial.
Measured: conclusion of the study
Secondary outcomes (1)
Is to monitor local DTH responses in vivo against the antigen-loaded DCs after booster immunizations.
Measured: conclusion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startSep 2001
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH), Rockefeller University
- Investigators
- James Young, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700167
- Sponsor's protocol ID
- 98-098
- Other IDs
- NIH CA33049
- Status last verified
- Apr 2011
- First submitted
- 17 Jun 2008
- Last updated
- 20 Apr 2011
- Results posted
- No
Publications
Romano E, Rossi M, Ratzinger G, de Cos MA, Chung DJ, Panageas KS, Wolchok JD, Houghton AN, Chapman PB, Heller G, Yuan J, Young JW. Peptide-loaded Langerhans cells, despite increased IL15 secretion and T-cell activation in vitro, elicit antitumor T-cell responses comparable to peptide-loaded monocyte-derived dendritic cells in vivo. Clin Cancer Res. 2011 Apr 1;17(7):1984-97. doi: 10.1158/1078-0432.CCR-10-3421. Epub 2011 Feb 25.
PubMed 21355077
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Responses To Antigen-Bearing Dendritic Cells in Patients With Malignancy - A Phase I Trial in Melanoma
- ClinicalTrials.gov ID
- NCT00700167
- Acronym / sponsor ID
- 98-098
- Conditions
- Melanoma
- Keywords
- ANTIGENBEARING DENDRITIC CELLS, 98-098
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH), Rockefeller University
- Study start
- Sep 2001
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 18 Jun 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.
Cancer cells make proteins called antigens that act as markers for the tumor cells. These antigens cannot cause the cancer itself. Special white blood cells, called T cells or T lymphocytes, recognize and respond to antigens. In many diseases, these and other cells in the immune system help your body get rid of the disease. However, T cells are normally resting, and they need other proteins on the diseased cell surface to begin working. Unfortunately, cancer cells do not usually make all the other proteins that T cells need to work. Therefore, T cells do not normally work against the cancer cells. We think this is one of the reasons that cancers grow and are not rejected by the body in the first place.
Another white blood cell, called a dendritic cell, does have most if not all of the special proteins needed to make T cells work to destroy cancer cells. However, dendritic cells do not normally have the cancer proteins on their surface. The challenge then is to combine the cancer markers (antigens) with these dendritic cells to make a vaccine. We think that the body's T cells might then react against the tumor and help destroy it. This study will see if putting tumor antigens made in a lab onto dendritic cells will make T cells work against tumor cells. We want to answer this question by injecting you with dendritic cells loaded with the antigens. Then we will check for a response based on lab studies and your own clinical course. We will compare your response against melanoma with your response against a common antigen, to which almost everyone has already been exposed. Flu, for example, is a common antigen to which most people have been exposed. We also need to test your response to an antigen that your body has not likely seen before. For example, we plan to use KLH (keyhole limpet hemocyanin), which is a pigment or color protein made from a sea creature known as a keyhole limpet. Each of these, the flu and KLH antigens, which should be harmless to you, will be used along with the dendritic cell-tumor vaccine. This will help us find out if the vaccine is working, based on the lab studies we will check before and after the vaccinations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: dendritic cell vaccineThe vaccine will be split between as many as 10 injections, more or less. Each shot will be about 1/25th to 1/50th of a teaspoon (100 to 200 microliters). Each vaccine will be injected with a tiny needle just under your skin. This will usually cause a very small area of swelling at the injection site that may last for a few minutes to an hour or so. You will receive two additional "booster" doses of the same vaccine every 4-6 weeks. This would mean that you receive a total of three vaccines over about 2-3 months. The vaccines will be given during an outpatient visit. If for some reason, you happen to be in the hospital, you can still receive the vaccines. These visits should take no longer than 15-30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of metastatic melanoma, AJCC stage III or IV, with histologic confirmation by Dept. of Pathology at MSKCC.
- Patients must be HLA-A*0201 positive.
- Expected survival of greater than 3 months.
- Karnofsky performance status 70 or better.
- Patients may not have received chemotherapy, immunotherapy, or radiation within approximately 4 weeks (approximately 6 weeks for nitrosoureas or mitomycin) before participation in this protocol.
Key exclusion criteria (12 listed)
- Pregnant (clinically documented or positive pregnancy test within approximately 2 wks of study entry) or lactating women, because immunization will include differentiation antigens shared by melanoma tumors and melanocytes, and immune responses to these differentiation antigens could have unknown developmental sequelae to a fetus or infant.
- Pregnancy tests are not required for post-menopausal women, and post-menopausal status by patient report should be documented accordingly.
- Patients requiring systemic corticosteroids or comparable exogenous immunosuppressive agent(s) (no exclusion for use of NSAIDs)
- Patients who have a known immunodeficiency (e.g., infection with HTLV-1,2, HIV-1,2; etc.) because of the T cell defects that would alter their responses and the investigators' ability to assess their outcomes accurately.
- Patients with preexisting retinal or choroidal eye disease.
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 vaccineThe vaccine will be split between as many as 10 injections, more or less. Each shot will be about 1/25th to 1/50th of a teaspoon (100 to 200 microliters). Each vaccine will be injected with a tiny needle just under your skin. This will usually cause a very small area of swelling at the injection site that may last for a few minutes to an hour or so. You will receive two additional "booster" doses of the same vaccine every 4-6 weeks. This would mean that you receive a total of three vaccines over about 2-3 months. | Biological | 1 |
Primary outcome
Evaluate safety and toxicity of immunizations of patients with stage III/IV melanoma, using autologous DCs pulsed with antigenic peptides expressed by melanoma, together with class I MHC (influenza) and class II MHC (KLH) -restricted control antigens.
Time frame: conclusion of the study
Evaluate further the immunogenicity of tumor antigen-bearing dendritic cells, based on the same in vitro assays as above, measured pre-& post-dendritic cell immunization with the optimal biologic dose of DCs selected in the phase Ia portion of the trial.
Time frame: conclusion of the study
1 secondary outcome
Is to monitor local DTH responses in vivo against the antigen-loaded DCs after booster immunizations.
Time frame: conclusion of the 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 20 Apr 2011.
- Derived from this study: PubMed 21355077Romano E, Rossi M, Ratzinger G, de Cos MA, Chung DJ, Panageas KS, Wolchok JD, Houghton AN, Chapman PB, Heller G, Yuan J, Young JW. Peptide-loaded Langerhans cells, despite increased IL15 secretion and T-cell activation in vitro, elicit antitumor T-cell responses comparable to peptide-loaded monocyte-derived dendritic cells in vivo. Clin Cancer Res. 2011 Apr 1;17(7):1984-97. doi: 10.1158/1078-0432.CCR-10-3421. Epub 2011 Feb 25.
- Memorial Sloan-Kettering Cancer CenterLink 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.
James Young, MD principal investigator
Memorial Sloan Kettering Cancer 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 study testing dendritic cell vaccine in people with Melanoma, run by Memorial Sloan Kettering Cancer Center 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 6 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: finished, as of the sponsor's last update on 20 Apr 2011. 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?
Evaluate safety and toxicity of immunizations of patients with stage III/IV melanoma, using autologous DCs pulsed with antigenic peptides expressed by melanoma, together with class I MHC (influenza) and class II MHC (KLH) -restricted control antigens. (time frame: conclusion of the 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?
On the ClinicalTrials.gov record for NCT00700167, which also lists 1 linked publication.
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 20 Apr 2011.