Malignant MelanomaPhase 2NCT01543464
Peptide Vaccine and Temozolomide for Metastatic Melanoma Patients
A Phase 2 study testing Chemotherapy: Temozolomide in people with Malignant Melanoma, run by Inge Marie Svane at 1 site in Denmark.
Trial summary
The aim of the study is to assess if treatment with IDO/Survivin peptide vaccine can enhance the efficacy of temozolomide chemotherapy in patients with metastatic malignant melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- Chemotherapy: Temozolomide
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteDenmark
- Study dates
- May 2012to Sep 2016
- Phase
- Phase 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
- Histological verified malignant melanoma
- Metastatic disease (brain metastasis allowed if asymptomatic)
- Evaluable disease recording to RECIST v. 1.1
- Age > 18 years
- Performance status, PS=0, PS=1 or PS=2
- Life expectancy > 3 months
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- Adequate bone marrow function
- Leucocyte count > 2,5 * 109/L
- Granulocyte count > 1,5 * 109/L
- Thrombocyte count > 100 * 109/l
- Creatinine < 2,5 * UNL 130 micromol/L
- Adequate liver function
- ASAT < 100 U/L
- Bilirubin < 300 U/L
- S-hCG negative (fertile women)
- Written informed consent
- Inclusion at least 4 weeks after major abdominal surgery
- If radiotherapy for brain metastases prior to inclusion, then progressive disease proven by new brain MR-scan before inclusion
Who cannot join
- Treatment with immune suppressors (ie. prednisone) not allowed
- Other malignancies 3 years prior to inclusion except benign skin lesions
- Severe medical condition, severe asthma, severe COL, severe heart- or diabetic disease
- Acute/Chronic infection with HIV, hepatitis or tuberculosis
- Known severe allergic reactions
- Former anaphylactic reactions
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- Active autoimmune diseases
- Pregnant or nourishing women
- Psychiatric disease resulting in non-compliance
- Known allergic reactions towards Montanide, Imiquimod, Temozolomide or Leukine
- Simultaneously treatment with other experimental drugs
- Patients cannot be treated with chemotherapy, radiotherapy (except locally) or immunotherapy 14 days within inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combination of IDO/Survivin Peptide Vaccine, GM-CSF, Imiquimod and Temozolomide Chemotherapy for Patients With Metastatic Malignant Melanoma
The aim of the study is to assess if treatment with IDO/Survivin peptide vaccine can enhance the efficacy of temozolomide chemotherapy in patients with metastatic malignant melanoma.
Read the detailed description
Secondarily to studying the efficacy of the treatment; the investigators examine if treatment with IDO/Survivin peptide can induce a measurable cellular T-cell response when the vaccine is given in combination with temozolomide treatment for melanoma patients.
- Conditions
- Malignant Melanoma
- Being tested
- Chemotherapy: Temozolomide
- Keywords
- Indeolamine 2,3 dioxygenase, Survivin, Montanide, Imiquimod, GMCSF
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemotherapy: TemozolomideDrug
Vaccine: 250 microgram IDO5 peptide + 250 microgram Survivin peptide + 500 microL Montanide every 2nd week Adjuvants: 75 microgram GM-CSF + 1 application Imiquimod every 2nd week
| Study group | Role | What they receive |
|---|---|---|
| Vaccine+adjuvants+temozolomide treatment | Experimental | Experimental arm Receives: Drug: Chemotherapy: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical benefit rate (CBR)
Primary endpoint is clinical benefit rate defined as complete remission rate + partial response + stable disease for a minimum of 6 months plus assessment of time to progression (TTP).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: Diminished rectruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inge Marie Svane
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital at Herlev
- Responsible party
- Sponsor-investigator, Inge Marie Svane, Herlev Hospital
- Investigators
- Trine Zeeberg Iversen, MD, Principal investigator, Center for Cancer ImmuneTherapyInge Marie Svane, MD, PhD, Prof., Study director, Center for Cancer ImmunoTherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543464
- Sponsor's protocol ID
- MM1120
- Status last verified
- Mar 2018
- First submitted
- 8 Feb 2012
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of IDO/Survivin Peptide Vaccine, GM-CSF, Imiquimod and Temozolomide Chemotherapy for Patients With Metastatic Malignant Melanoma
- ClinicalTrials.gov ID
- NCT01543464
- Acronym / sponsor ID
- MM1120
- Conditions
- Malignant Melanoma
- Keywords
- Indeolamine 2,3 dioxygenase, Survivin, Montanide, Imiquimod, GMCSF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Diminished rectruitment
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Inge Marie SvaneUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital at Herlev
- Study start
- May 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 5 Mar 2012 (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 aim of the study is to assess if treatment with IDO/Survivin peptide vaccine can enhance the efficacy of temozolomide chemotherapy in patients with metastatic malignant melanoma.
Detailed description
Secondarily to studying the efficacy of the treatment; the investigators examine if treatment with IDO/Survivin peptide can induce a measurable cellular T-cell response when the vaccine is given in combination with temozolomide treatment for melanoma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccine+adjuvants+temozolomide treatment | Experimental | Drug: Chemotherapy: TemozolomideExperimental arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histological verified malignant melanoma
- Metastatic disease (brain metastasis allowed if asymptomatic)
- Evaluable disease recording to RECIST v. 1.1
- Age > 18 years
- Performance status, PS=0, PS=1 or PS=2
Key exclusion criteria (12 listed)
- Treatment with immune suppressors (ie. prednisone) not allowed
- Other malignancies 3 years prior to inclusion except benign skin lesions
- Severe medical condition, severe asthma, severe COL, severe heart- or diabetic disease
- Acute/Chronic infection with HIV, hepatitis or tuberculosis
- Known severe allergic 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 |
|---|---|---|
| Chemotherapy: TemozolomideVaccine: 250 microgram IDO5 peptide + 250 microgram Survivin peptide + 500 microL Montanide every 2nd week Adjuvants: 75 microgram GM-CSF + 1 application Imiquimod every 2nd week | Drug | Vaccine+adjuvants+temozolomide treatment |
Primary outcome
Clinical benefit rate (CBR)
Time frame: 18 months
Primary endpoint is clinical benefit rate defined as complete remission rate + partial response + stable disease for a minimum of 6 months plus assessment of time to progression (TTP).
Results and safety
The study was stopped early (reason given: Diminished rectruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
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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.
Trine Zeeberg Iversen, MD principal investigator
Center for Cancer ImmuneTherapy
Inge Marie Svane, MD, PhD, Prof. study director
Center for Cancer ImmunoTherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chemotherapy: Temozolomide in people with 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 18 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 19 Mar 2018. 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 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: Diminished rectruitment). 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?
Clinical benefit rate (CBR) (time frame: 18 months). 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 Mar 2018.