Metastatic MelanomaPhase 1/2NCT00279058
The Role of Peptide-loaded Dendritic Cells to Augment the Therapeutic Effect of Interleukin-2
A Phase 1/2 study testing Immunotherapy treatment for melanoma in people with Metastatic Melanoma, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Melanoma is the main cause of death in patients with skin cancer. Once it has metastasized, this cancer has been shown to respond to chemotherapy only in rare cases. Immunotherapy represents an approach to treatment based on the immune response to cancer antigens. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- Immunotherapy treatment for melanoma
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2005to Dec 2008
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient age 18 to 65, with measurable metastatic melanoma who has an expected survival of greater than three months. All patients will be HLA-A2 positive
- Patient must have received accepted standard treatmnet for melanoma - DTIC -containing protocol ,unless unwilling.
- Patients who failed previous treatment with IL-2 will be included on a compassionate basis in the IL-2 plus vaccination scheme without being included in the analysis.
- serum creatinine of 2.0 mg/dl or less,
- Total bilirubin 1.6 mg/dl or less, except for patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl.
- WBC 3000/mm3 or greater
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- platelet count 90,000 mm3 or greater
- serum AST/ALT less then two times normal
- ECOG performance status of 0, 1 or 2.
- Patients of both genders must be willing to practice effective birth control during this trial.
- Patient agreed to participate in the study and has signed a written informed consent,
- The patient must be eligible to receive IL-2.
Who cannot join
- Patients will be excluded:
- who are undergoing or have undergone in the past 3 weeks any other form of therapy except from surgery for their cancer.
- have active systemic infections, coagulation disorders, autoimmune disease or other major medical illnesses of the cardiovascular or respiratory systems or any known immunodeficiency disease.
- who require steroid therapy.
- who are pregnant (because of possible side effects on the fetus).
- who are known to be positive for hepatitis BsAG, HCV, or HIV antibody (because of possible immune effects of these conditions).
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- who have any form of primary or secondary immunodeficiency. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)
- who are allergic to eggs.
- who have an active major medical illnesses such as cardiac ischemia as evidenced by a stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease (to be eligible to receive IL-2 ) j. Have an abnormal thyroid function (to be eligible to receive IL-2).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Autologous Dendritic Cells Pulsed by Melanoma Associated Peptides to Augment the Therapeutic Effect of Interleukin-2
Melanoma is the main cause of death in patients with skin cancer. Once it has metastasized, this cancer has been shown to respond to chemotherapy only in rare cases. Immunotherapy represents an approach to treatment based on the immune response to cancer antigens.
The principal objective of the study is to identify whether a dendritic cell-based vaccine can increase the moderate therapeutic effect of bolus high dose IL-2 in patients with metastatic melanoma. For this purpose,patients with metastatic melanoma who have a certain blood type (HLA-A201+) will be treated systemically with high dose IL-2. In one group of patients, the IL-2 will be preceded by three doses of autologous dendritic cell pulsed with melanoma antigens appropriate for their blood type. Two cycles of three DC vaccines will be administered every 14 days by intra-lymph node injections, followed by high dose IL-2 treatment. Responding patients will receive additional DC vaccines at 1 month and 2 months intervals.
Read more
In a second group, patients will receive the standard high dose IL-2 protocol within a comparable period of time.
Each group will include 12 patients.
A complete evaluation of evaluable lesions will be performed prior to accrual, after initial 3 DC vaccines, six weeks after first IL-2 treatment, after a total of 6 DC vaccines and 6 weeks after second cycle of IL-2 treatment.
- Conditions
- Metastatic Melanoma
- Being tested
- Immunotherapy treatment for melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunotherapy treatment for melanomaProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete evaluation of untreated lesions with physical examination and appropriate X-rays and/or scans will be performed four to six weeks after the last DC injection.
Immunological evaluation will be performed two weeks after the last DC injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2006 (estimated)
- Study startDec 2005
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Michal Lotem, MD, Principal investigator, Hadassah Medical Organization, pob 12000, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279058
- Sponsor's protocol ID
- pepDCIL2- HMO-CTIL
- Status last verified
- Apr 2007
- First submitted
- 17 Jan 2006
- Last updated
- 21 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Autologous Dendritic Cells Pulsed by Melanoma Associated Peptides to Augment the Therapeutic Effect of Interleukin-2
- ClinicalTrials.gov ID
- NCT00279058
- Acronym / sponsor ID
- pepDCIL2- HMO-CTIL
- Conditions
- Metastatic Melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 19 Jan 2006 (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.
Melanoma is the main cause of death in patients with skin cancer. Once it has metastasized, this cancer has been shown to respond to chemotherapy only in rare cases. Immunotherapy represents an approach to treatment based on the immune response to cancer antigens.
The principal objective of the study is to identify whether a dendritic cell-based vaccine can increase the moderate therapeutic effect of bolus high dose IL-2 in patients with metastatic melanoma. For this purpose,patients with metastatic melanoma who have a certain blood type (HLA-A201+) will be treated systemically with high dose IL-2. In one group of patients, the IL-2 will be preceded by three doses of autologous dendritic cell pulsed with melanoma antigens appropriate for their blood type. Two cycles of three DC vaccines will be administered every 14 days by intra-lymph node injections, followed by high dose IL-2 treatment. Responding patients will receive additional DC vaccines at 1 month and 2 months intervals.
In a second group, patients will receive the standard high dose IL-2 protocol within a comparable period of time.
Each group will include 12 patients.
A complete evaluation of evaluable lesions will be performed prior to accrual, after initial 3 DC vaccines, six weeks after first IL-2 treatment, after a total of 6 DC vaccines and 6 weeks after second cycle of IL-2 treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Any patient age 18 to 65, with measurable metastatic melanoma who has an expected survival of greater than three months. All patients will be HLA-A2 positive
- serum creatinine of 2.0 mg/dl or less,
- Total bilirubin 1.6 mg/dl or less, except for patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl.
- WBC 3000/mm3 or greater
- platelet count 90,000 mm3 or greater
Key exclusion criteria (9 listed)
- who are undergoing or have undergone in the past 3 weeks any other form of therapy except from surgery for their cancer.
- have active systemic infections, coagulation disorders, autoimmune disease or other major medical illnesses of the cardiovascular or respiratory systems or any known immunodeficiency disease.
- who require steroid therapy.
- who are pregnant (because of possible side effects on the fetus).
- who are known to be positive for hepatitis BsAG, HCV, or HIV antibody (because of possible immune effects of these conditions).
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 |
|---|---|---|
| Immunotherapy treatment for melanoma | Procedure or surgery | – |
Primary outcome
Complete evaluation of untreated lesions with physical examination and appropriate X-rays and/or scans will be performed four to six weeks after the last DC injection.
Immunological evaluation will be performed two weeks after the last DC injection.
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 21 Apr 2015.
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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.
Michal Lotem, MD principal investigator
Hadassah Medical Organization, pob 12000, Jerusalem, Israel
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 Immunotherapy treatment for melanoma in people with Metastatic Melanoma, run by Hadassah Medical Organization at 1 site in Israel.
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 12 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 21 Apr 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 Israel. 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 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?
Complete evaluation of untreated lesions with physical examination and appropriate X-rays and/or scans will be performed four to six weeks after the last DC injection.. 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?
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 21 Apr 2015.