Breast CancerPhase 1NCT00978913
Transfected Dendritic Cell Based Therapy for Patients With Breast Cancer or Malignant Melanoma
A Phase 1 study testing DC vaccine in people with Breast Cancer and Malignant Melanoma, run by Inge Marie Svane at 1 site in Denmark.
Trial summary
The primary aim of this study is to evaluate the toxicity of the vaccine and the combination of the vaccine and Cyclophosphamide, and to evaluate the immune response induced by the vaccine. The secondary aim is to investigate the clinical tumour response and duration of tumour and immune response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Malignant Melanoma
- What is being tested?
- DC vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2009to May 2014
- 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
- Histological verified metastatic breast cancer or malignant melanoma, in progression
- ≥ 18 years
- the patient must be habil
- Performance status ≤ 1 on Zubrod-ECOG-WHO-scale
- Leukocytes and platelets must be ≥normal. Hg ≥ 6.0
- creatinin must be normal
Show all 10Show fewer
- Liverparametre <2.5 x normal. Bilirubin <30
- Expected survival > 3 months
- Informed consent
- 11. At least one measurable lesion according to RECIST criteria.
Who cannot join
- Indication for chemotherapy
- Other malignancies
- Brain metastases
- severe medical condition
- Acute/chronic infection with ex. HIV, hepatitis, tuberculose
- Severe allergy
Show all 9Show fewer
- Autoimmune disease
- Other treatment with immune suppressing agents, other anticancer agents or experimental drugs
- Uncontrolled hypercalcemia.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Oncology, Herlev University Hospital
Herlev, Dk 2730
About this study
Official title: Evaluation of Dendritic Cells Transfected With Survivin, hTERT and p53 mRNA as a Treatment for Patients With Metastatic Breast Cancer or Malignant Melanoma
The primary aim of this study is to evaluate the toxicity of the vaccine and the combination of the vaccine and Cyclophosphamide, and to evaluate the immune response induced by the vaccine. The secondary aim is to investigate the clinical tumour response and duration of tumour and immune response.
Read the detailed description
Phase I trial. Single center study; patients will be referred to the study center from other institutions in Denmark. 14 patients will be included in this phase I trial DC vaccination regime consists of primary 6 biweekly intradermal injections with transfected dendritic cells, followed by monthly injections until progression; Cyclophosphamide is used as vaccine adjuvant.
Defined procedures are employed for generation of autologous dendritic cells for clinical application in a classified laboratory. Unmobilized leukapheresis will be used for isolation of large-scale mononuclear cells, and dendritic cells will be generated from monocytes by cytokine stimulation and transfected with mRNA encoding for hTERT, survivin and p53 if the tumour express p53. Frozen preparations of dendritic cells will be prepared using automated cryopreservation. Each patient will receive a minimum of 1x106 dendritic cells per treatment supplemented with Cyclophosphamide 50 mg twice a day every second week. Toxicity including autoimmunity will be evaluated using the Common Toxicity Criteria (CTC).
- Conditions
- Breast Cancer, Malignant Melanoma
- Being tested
- DC vaccine
- Keywords
- dendritic cell, cancervaccine, breast cancer, malignant melanoma, Cyclophosphamide
- Medical subject headings
- Breast Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC vaccineBiological
Also called dendritic cell vaccine, Cyclophosphamide, Sendoxan®, Baxter
DC vaccination, one vaccine biweekly
| Study group | Role | What they receive |
|---|---|---|
| DC vaccination and Cyclophosphamide | Experimental | Not described Receives: Biological: DC vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the toxicity of the vaccine in combination with Cyclophosphamide
Measured: biweekly
Secondary outcomes (3)
to investigate the clinical tumor response and the duration
Measured: after 12 weeks
to evaluate the duration of tumor and immunoresponse
Measured: 3, 6, 9 months
to evaluate immune response
Measured: at 8 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionAug 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inge Marie Svane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Inge Marie Svane, Herlev Hospital
- Investigators
- Inge Marie Svane, prof.MD, Study director, Department of Oncology, Herlev University Hospital, Herlev Ringvej 75,2730 Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978913
- Sponsor's protocol ID
- AA 0914
- Status last verified
- Aug 2015
- First submitted
- 16 Sep 2009
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dendritic Cells Transfected With Survivin, hTERT and p53 mRNA as a Treatment for Patients With Metastatic Breast Cancer or Malignant Melanoma
- ClinicalTrials.gov ID
- NCT00978913
- Acronym / sponsor ID
- AA 0914
- Conditions
- Breast Cancer, Malignant Melanoma
- Keywords
- dendritic cell, cancervaccine, breast cancer, malignant melanoma, Cyclophosphamide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Inge Marie SvaneUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Aug 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 17 Sep 2009 (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 primary aim of this study is to evaluate the toxicity of the vaccine and the combination of the vaccine and Cyclophosphamide, and to evaluate the immune response induced by the vaccine. The secondary aim is to investigate the clinical tumour response and duration of tumour and immune response.
Detailed description
Phase I trial. Single center study; patients will be referred to the study center from other institutions in Denmark. 14 patients will be included in this phase I trial DC vaccination regime consists of primary 6 biweekly intradermal injections with transfected dendritic cells, followed by monthly injections until progression; Cyclophosphamide is used as vaccine adjuvant.
Defined procedures are employed for generation of autologous dendritic cells for clinical application in a classified laboratory. Unmobilized leukapheresis will be used for isolation of large-scale mononuclear cells, and dendritic cells will be generated from monocytes by cytokine stimulation and transfected with mRNA encoding for hTERT, survivin and p53 if the tumour express p53. Frozen preparations of dendritic cells will be prepared using automated cryopreservation. Each patient will receive a minimum of 1x106 dendritic cells per treatment supplemented with Cyclophosphamide 50 mg twice a day every second week. Toxicity including autoimmunity will be evaluated using the Common Toxicity Criteria (CTC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DC vaccination and Cyclophosphamide | Experimental | Biological: DC vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histological verified metastatic breast cancer or malignant melanoma, in progression
- ≥ 18 years
- the patient must be habil
- Performance status ≤ 1 on Zubrod-ECOG-WHO-scale
- Leukocytes and platelets must be ≥normal. Hg ≥ 6.0
Key exclusion criteria (9 listed)
- Indication for chemotherapy
- Other malignancies
- Brain metastases
- severe medical condition
- Acute/chronic infection with ex. HIV, hepatitis, tuberculose
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 |
|---|---|---|
| DC vaccineAlso: dendritic cell vaccine, Cyclophosphamide, Sendoxan®, BaxterDC vaccination, one vaccine biweekly | Biological | DC vaccination and Cyclophosphamide |
Primary outcome
to evaluate the toxicity of the vaccine in combination with Cyclophosphamide
Time frame: biweekly
3 secondary outcomes
to investigate the clinical tumor response and the duration
Time frame: after 12 weeks
to evaluate the duration of tumor and immunoresponse
Time frame: 3, 6, 9 months
to evaluate immune response
Time frame: at 8 and 12 weeks
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 19 Aug 2015.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Inge Marie Svane, prof.MD study director
Department of Oncology, Herlev University Hospital, Herlev Ringvej 75,2730 Herlev
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 DC vaccine in people with Breast Cancer and Malignant Melanoma, run by Inge Marie Svane at 1 site in Denmark.
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 9 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 19 Aug 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 Denmark. 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?
to evaluate the toxicity of the vaccine in combination with Cyclophosphamide (time frame: biweekly). 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 19 Aug 2015.