Metastatic Malignant MelanomaPhase 1/2NCT00961844
Trial for Vaccine Therapy With Dendritic Cells in Patients With Metastatic Malignant Melanoma
A Phase 1/2 study testing Dendritic cells - transfected with hTERT-, survivin- and tumor cell derived mRNA + ex vivo T cell expansion and reinfusion and Temozolomide in people with Metastatic Malignant Melanoma, run by Steinar Aamdal at 1 site in Norway.
Trial summary
In this trial the investigators want to combine chemotherapy with immunotherapy by giving the patients Temozolomide, before vaccination. The investigators have also included hTERT and survivin mRNA in the vaccine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Malignant Melanoma
- What is being tested?
- Dendritic cells - transfected with hTERT-, survivin- and tumor cell derived mRNA + ex vivo T cell expansion and reinfusion and Temozolomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2009to Jun 2012
- 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 verified malignant melanoma with measurable (according to RECIST), unresectable metastases (Stage III or Stage IV M1a-c as defined by criteria of the AJCC Cancer Staging Manual, 6 th. Edition 2002). Patients with a melanoma of an unknown primary site are eligible.
- Preferably accessible tumor tissue with enough volume and quality for vaccine production (extraction of tumor mRNA)
- Must be at least 18 years of age
- Must be ambulatory with a ECOG performance status 0 or 1
- Life expectancy ≥ 6 months
- Negative MRI of the brain
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- Must have lab values as the following:
- ANC ≥ 1.5 x 109/L
- Platelets ≥ 100 x 109/L
- Hb ≥ 9 g/dL (≥ 5.6 mmol/L)
- Creatinine ≤ 140 μmol/L (1.6 mg/dL); if borderline, the creatinine clearance ≥ 40 mL/min
- Bilirubin < 20% above the upper limit of normal
- ASAT and ALAT ≤ 2.5 the upper limit of normal
- Albumin ≥ 2.5 g/L
- If the patient is female, she must practice adequate contraception during the study treatment
- Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH/GCP, and national/local regulations
Who cannot join
- The patient suffers from an ocular- or mucous membrane melanoma
- History of prior malignancy other than melanoma, except for curatively treated basal cell or squamous cell carcinoma of the skin and cervix cancer stage 1B or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.
- Active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune systems. PI shall make the final determination regarding appropriateness of enrollment
- Autoimmune disease currently being treated with systemic steroids Version no. 3, 18 June 2009 Page 17 of 50
- Adverse reactions to vaccines such as anaphylaxis or other serious reactions
- History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis-dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome
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- Positive for HIV, Hepatitis B and C and Syphilis (treponema pallidum)
- Pregnancy or lactation
- If the patient has received any prior anti-cancer treatment, including radiotherapy, chemotherapy immunotherapy and/or immunomodulating agents, this must have been stopped at least 4 weeks before first study treatment administration.
- Chemotherapy, glucocorticosteroids or other potentially immune-suppressive therapy that has been administered within 4 weeks prior to vaccination
- No treatment with dacarbazine or temozolomide at any time prior to study entry
- Any reason why, in the opinion of the investigator, the patient should not participate
Trial locations and contacts
1 site in 1 country.
Norway1 site
The Norwegian Radium Hospital, Department of Clinical Cancer Research
Oslo, Montebello, NO-0310
About this study
Official title: Phase I/II Trial for Vaccine Therapy With Dendritic Cells - Transfected With hTERT-, Survivin- and Tumor Cell Derived mRNA + ex Vivo T Cell Expansion and Reinfusion in Patients With Metastatic Malignant Melanoma
In this trial the investigators want to combine chemotherapy with immunotherapy by giving the patients Temozolomide, before vaccination. The investigators have also included hTERT and survivin mRNA in the vaccine. Finally, the investigators want to introduce ex vivo T cell expansion after lymphodepletion for the patients who show an immune response.
- Conditions
- Metastatic Malignant Melanoma
- Being tested
- Dendritic cells - transfected with hTERT-, survivin- and tumor cell derived mRNA + ex vivo T cell expansion and reinfusion, Temozolomide
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dendritic cells - transfected with hTERT-, survivin- and tumor cell derived mRNA + ex vivo T cell expansion and reinfusionBiological
TemozolomideDrug
| Study group | Role | What they receive |
|---|---|---|
| DC vaccine + Temozolomide | Experimental | Dendritic cell loaded with h-TERT mRNA, survivin mRNA and autologous tumor cell mRNA, lymphodepletion treatment and T cell expansion and reinfusion. Receives: Biological: Dendritic cells - transfected with hTERT-, survivin- and tumor cell derived mRNA + ex vivo T cell expansion and reinfusion; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and toxicity of vaccination with DC transfected h-TERT mRNA, survivin mRNA and tumor cell mRNA, lymphodepletion treatment and T cell expansion and reinfusion in patients with metastatic malignant melanoma.
Secondary outcomes (1)
Evaluation of immunological responses, time to disease progression and survival time.
Measured: 5 years of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: Logistical problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Malignant 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steinar Aamdal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Steinar Aamdal, Oslo University Hospital
- Investigators
- Steinar Aamdal, M.D PhD Prof, Principal investigator, Oslo University Hospital - Norwegian Radium Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961844
- Sponsor's protocol ID
- DC-004
- Other IDs
- 2008-006253-41, 2008
- Status last verified
- Feb 2021
- First submitted
- 12 Aug 2009
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial for Vaccine Therapy With Dendritic Cells - Transfected With hTERT-, Survivin- and Tumor Cell Derived mRNA + ex Vivo T Cell Expansion and Reinfusion in Patients With Metastatic Malignant Melanoma
- ClinicalTrials.gov ID
- NCT00961844
- Acronym / sponsor ID
- DC-004
- Conditions
- Metastatic Malignant Melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Logistical problems
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Steinar AamdalUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 19 Aug 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.
In this trial the investigators want to combine chemotherapy with immunotherapy by giving the patients Temozolomide, before vaccination. The investigators have also included hTERT and survivin mRNA in the vaccine. Finally, the investigators want to introduce ex vivo T cell expansion after lymphodepletion for the patients who show an immune response.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DC vaccine + Temozolomide | Experimental | Biological: Dendritic cells - transfected with hTERT-, survivin- and tumor cell derived mRNA + ex vivo T cell expansion and reinfusion, Drug: TemozolomideDendritic cell loaded with h-TERT mRNA, survivin mRNA and autologous tumor cell mRNA, lymphodepletion treatment and T cell expansion and reinfusion. |
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 verified malignant melanoma with measurable (according to RECIST), unresectable metastases (Stage III or Stage IV M1a-c as defined by criteria of the AJCC Cancer Staging Manual, 6 th. Edition 2002). Patients with a melanoma of an unknown primary site are eligible.
- Preferably accessible tumor tissue with enough volume and quality for vaccine production (extraction of tumor mRNA)
- Must be at least 18 years of age
- Must be ambulatory with a ECOG performance status 0 or 1
- Life expectancy ≥ 6 months
Key exclusion criteria (12 listed)
- The patient suffers from an ocular- or mucous membrane melanoma
- History of prior malignancy other than melanoma, except for curatively treated basal cell or squamous cell carcinoma of the skin and cervix cancer stage 1B or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.
- Active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune systems. PI shall make the final determination regarding appropriateness of enrollment
- Autoimmune disease currently being treated with systemic steroids Version no. 3, 18 June 2009 Page 17 of 50
- Adverse reactions to vaccines such as anaphylaxis or other serious reactions
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 cells - transfected with hTERT-, survivin- and tumor cell derived mRNA + ex vivo T cell expansion and reinfusion | Biological | DC vaccine + Temozolomide |
| Temozolomide | Drug | DC vaccine + Temozolomide |
Primary outcome
Safety and toxicity of vaccination with DC transfected h-TERT mRNA, survivin mRNA and tumor cell mRNA, lymphodepletion treatment and T cell expansion and reinfusion in patients with metastatic malignant melanoma.
1 secondary outcome
Evaluation of immunological responses, time to disease progression and survival time.
Time frame: 5 years of follow-up.
Results and safety
The study was stopped early (reason given: Logistical problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
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RecruitingPhase 2
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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.
Steinar Aamdal, M.D PhD Prof principal investigator
Oslo University Hospital - Norwegian Radium Hospital
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 cells - transfected with hTERT-, survivin- and tumor cell derived mRNA + ex vivo T cell expansion and reinfusion and Temozolomide in people with Metastatic Malignant Melanoma, run by Steinar Aamdal at 1 site in Norway.
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 26 Feb 2021. 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 Norway. 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: Logistical problems). 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?
Safety and toxicity of vaccination with DC transfected h-TERT mRNA, survivin mRNA and tumor cell mRNA, lymphodepletion treatment and T cell expansion and reinfusion in patients with metastatic malignant melanoma.. 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 26 Feb 2021.