MelanomaPhase 1/2NCT01944709
Phase I/II Study of Vaccination With Antigen Loaded Dendritic Cells (DCs) in Patients With Inoperable Stage III and Stage IV Melanoma
A Phase 1/2 study testing Dendritic cell application in people with Melanoma, run by Prof. Dr. Silke Gillessen at 1 site in Switzerland.
Trial summary
The prognosis of patients with metastatic melanoma is poor and current available treatments are limited. Identification of a number of melanoma-specific tumor antigens that are shared by tumors from different patients, provides attractive targets for immune-based therapies (http://www.bioinfo.org.cn/hptaa/). 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 application
- How many people
- 2 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2006to Dec 2010
- 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
- Histologically confirmed melanoma
- Inoperable Stage III or Stage IV melanoma
- Tumor expression of Melan-A and/or NY-Eso-1 by immunohistochemistry
- Human leukocyte antigen (HLA)-A0201 positivity (flow cytometry and PCR)
- Life expectancy more than three months
- Full recovery from surgery
Show all 16Show fewer
- Karnofsky scale performance status of 70% or more (App II)
- One prior chemo- or cytokine based therapy is allowed
- Age > 18 years
- No uncontrolled infections
- Neutrophile count >1500/ul and thrombocytes >100 000/ul
- Creatinine <1.5 of upper normal level
- Adequate liver function with bilirubin <2 of upper normal level, alanine aminotransferase (ALAT) and aspartate aminotransaminase (ASAT) < 3 x upper normal level
- Clinically significant (i.e. active) cardiovascular disease: Cardiovascular accident (CVA)/stroke (< 6 months prior to enrolment), myocardial infarction (< 6 months prior to enrolment), unstable angina, congestive heart failure or serious cardiac arrythmia requiring medication
- absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- before patient registration, informed consent must be given according to International Conference on Harmonization (ICH)- Good Clinical Practice (GCP), and national/local regulations
Who cannot join
- Presently clinically significant heart disease (NYHA Class III or IV)
- Other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders or uncontrolled peptic ulcer, or seizure or central nervous system disorders
- History of immunodeficiency disease or severe autoimmune disease
- Metastatic disease to the central nervous system
- HIV, hepatitis B virus (HBV), hepatitis C virus (HCV) (test required) or any other severe uncontrolled infection
- Chemotherapy, radiation therapy, or immunotherapy within 4 weeks before study entry
Show all 13Show fewer
- Concomitant treatment with steroids or antihistamine drugs. Topical or inhalational steroids are permitted
- Participation in any other clinical trial involving another investigational agent within 6 weeks prior to enrollment
- Pregnancy or lactation
- Women of childbearing potential not using a medically acceptable means of contraception
- Lack of availability of the patient for immunological and clinical follow-up assessment.
- Coagulation or bleeding disorders
- Rapidly progressing disease
Trial locations and contacts
1 site in 1 country.
About this study
The prognosis of patients with metastatic melanoma is poor and current available treatments are limited. Identification of a number of melanoma-specific tumor antigens that are shared by tumors from different patients, provides attractive targets for immune-based therapies (http://www.bioinfo.org.cn/hptaa/). Different approaches like DNA-/RNA-vaccines, peptide vaccines and dendritic cell (DC) vaccines are under investigation to induce peptide-specific immune responses. In various animal models and in clinical trials it was shown that the most potent induction of anti tumor-specific killer cells was achieved with DC vaccination. DCs are professional antigen presenting cells (APC) that are critical in the initiation of cellular responses in naïve T lymphocytes, in vivo. They are armed with all the molecules needed for the induction of immune responses and have the capacity to migrate into secondary lymphatic organs. In vitro generated dendritic cells are loaded with tumor derived peptides and injected subcutaneously. The concept is to induce or to propagate already existing tumor specific killer T cells.
- Conditions
- Melanoma
- Being tested
- Dendritic cell application
- Keywords
- melanoma, dendritic cells, peptide, Melan-A
- 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 applicationBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity as defined by NCI Common Toxicity Criteria Version 3.0 (App I)
If any grade III or IV toxicity occurs within 24 hours of the vaccine treatment, no further vaccinations will be given. Grade III or IV toxicities arising later will only lead to treatment termination if the toxicity is clinically significant and can be attributed to the vaccination.
Measured: 24 hours
Secondary outcomes (1)
Response rates in case of measurable disease
Three indicator lesions that are measurable in 2 diameters will be assessed radiologically. If there are not three measurable lesions, only the measurable lesions will be assessed.
Measured: 12 weeks, 20 weeks, 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startAug 2006
- Primary completionDec 2007
- Study completionDec 2010
Why it stopped: Progressive Disease
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.
- 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Silke Gillessen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. Silke Gillessen, Cantonal Hospital of St. Gallen
- Investigators
- Silke Gillessen, MD, Principal investigator, Cantonal Hospital St. Gallen, Dept. Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944709
- Sponsor's protocol ID
- SG269/06
- Status last verified
- Sep 2013
- First submitted
- 13 Sep 2013
- Last updated
- 18 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Vaccination With Antigen Loaded Dendritic Cells (DCs) in Patients With Inoperable Stage III and Stage IV Melanoma
- ClinicalTrials.gov ID
- NCT01944709
- Acronym / sponsor ID
- SG269/06
- Conditions
- Melanoma
- Keywords
- melanoma, dendritic cells, peptide, Melan-A
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Progressive Disease
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Prof. Dr. Silke GillessenUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 18 Sep 2013 (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 prognosis of patients with metastatic melanoma is poor and current available treatments are limited. Identification of a number of melanoma-specific tumor antigens that are shared by tumors from different patients, provides attractive targets for immune-based therapies (http://www.bioinfo.org.cn/hptaa/). Different approaches like DNA-/RNA-vaccines, peptide vaccines and dendritic cell (DC) vaccines are under investigation to induce peptide-specific immune responses. In various animal models and in clinical trials it was shown that the most potent induction of anti tumor-specific killer cells was achieved with DC vaccination. DCs are professional antigen presenting cells (APC) that are critical in the initiation of cellular responses in naïve T lymphocytes, in vivo. They are armed with all the molecules needed for the induction of immune responses and have the capacity to migrate into secondary lymphatic organs. In vitro generated dendritic cells are loaded with tumor derived peptides and injected subcutaneously. The concept is to induce or to propagate already existing tumor specific killer T cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically confirmed melanoma
- Inoperable Stage III or Stage IV melanoma
- Tumor expression of Melan-A and/or NY-Eso-1 by immunohistochemistry
- Human leukocyte antigen (HLA)-A0201 positivity (flow cytometry and PCR)
- Life expectancy more than three months
Key exclusion criteria (13 listed)
- Presently clinically significant heart disease (NYHA Class III or IV)
- Other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders or uncontrolled peptic ulcer, or seizure or central nervous system disorders
- History of immunodeficiency disease or severe autoimmune disease
- Metastatic disease to the central nervous system
- HIV, hepatitis B virus (HBV), hepatitis C virus (HCV) (test required) or any other severe uncontrolled infection
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 application | Biological | – |
Primary outcome
Toxicity as defined by NCI Common Toxicity Criteria Version 3.0 (App I)
Time frame: 24 hours
If any grade III or IV toxicity occurs within 24 hours of the vaccine treatment, no further vaccinations will be given. Grade III or IV toxicities arising later will only lead to treatment termination if the toxicity is clinically significant and can be attributed to the vaccination.
1 secondary outcome
Response rates in case of measurable disease
Time frame: 12 weeks, 20 weeks, 28 weeks
Results and safety
The study was stopped early (reason given: Progressive Disease). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2013.
Related trials for Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
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.
Silke Gillessen, MD principal investigator
Cantonal Hospital St. Gallen, Dept. Oncology
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 application in people with Melanoma, run by Prof. Dr. Silke Gillessen at 1 site in Switzerland.
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 13 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 18 Sep 2013. 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 Switzerland. 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 was stopped early (reason given: Progressive Disease). 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?
Toxicity as defined by NCI Common Toxicity Criteria Version 3.0 (App I) (time frame: 24 hours). 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 Sep 2013.