Cancer of SkinPhase 1/2NCT00278018
Peritumoral Injection of Immature Dendritic Cells to Irradiated Skin Metastases of Solid Tumors
A Phase 1/2 study testing Immunotherapy treatment for solid tumors in people with Cancer of Skin and Solid Tumors, 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 years and older
- Conditions the study is for
- Cancer of Skin, Solid Tumors
- What is being tested?
- Immunotherapy treatment for solid tumors
- Type of treatment
- Surgery or procedure
- How many people
- 20 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient above age 18, with measurable metastatic melanoma or other solid tumor, with at least one tumor deposit that is easily accessible to peri-tumoral DC injection. The preferred location is subcutaneous or intradermal. Patients with additional metastatic sites will not be excluded. Patients should have an expected survival of greater than three months.
- Patient must have received accepted standard treatment of his or her cancer:
- for melanoma - DTIC -containing protocol ,unless unwilling. Previous treatment with IL-2 is not an excluding factor.
- for breast cancer - adriamycin and cyclophosphamide, taxanes, and vinorelbine-containing protocols
- for lung, renal and GIT cancers- one previous chemotherapy line
- Serum creatinine of 2.0 mg/dl or less.
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- 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.
- 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.
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 B and C 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peritumoral Injection of Immature Dendritic Cels to Irradiated Metastases of Solid Tumors
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 long-term objective of this study is to develop a therapeutic approach for the treatment of cancer in general, and melanoma in particular, based on immunotherapy, using a combination of local tumor irradiation followed by injection of immature dendritic cells (iDC).The treatment will be followed by the injection of interferon alpha, which we expect will induce activation of the iDC.
This trial is based on the hypothesis that local radiation, which causes destruction of the tumor, in combination with injection of the patient's own iDC and the activation of these cells with interferon alpha, will induce an effective immune response against the tumor. In order to test the suggested approach, we propose a 20-patients clinical trial that will evaluate the objective clinical and immunological response to the proposed treatment in patients with malignant melanoma and other solid tumors.
- Conditions
- Cancer of Skin, Solid Tumors
- Being tested
- Immunotherapy treatment for solid tumors
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunotherapy treatment for solid tumorsProcedure 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 posted18 Jan 2006 (estimated)
- Study startDec 2005
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: Because there were no responses
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of SkinStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT00278018
- Sponsor's protocol ID
- immatureDC- HMO-CTIL
- Status last verified
- Apr 2007
- First submitted
- 16 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
- Peritumoral Injection of Immature Dendritic Cels to Irradiated Metastases of Solid Tumors
- ClinicalTrials.gov ID
- NCT00278018
- Acronym / sponsor ID
- immatureDC- HMO-CTIL
- Conditions
- Cancer of Skin, Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because there were no responses
- Enrolment
- 20 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
- 18 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 long-term objective of this study is to develop a therapeutic approach for the treatment of cancer in general, and melanoma in particular, based on immunotherapy, using a combination of local tumor irradiation followed by injection of immature dendritic cells (iDC).The treatment will be followed by the injection of interferon alpha, which we expect will induce activation of the iDC.
This trial is based on the hypothesis that local radiation, which causes destruction of the tumor, in combination with injection of the patient's own iDC and the activation of these cells with interferon alpha, will induce an effective immune response against the tumor. In order to test the suggested approach, we propose a 20-patients clinical trial that will evaluate the objective clinical and immunological response to the proposed treatment in patients with malignant melanoma and other solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- 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 (13 listed)
- Any patient above age 18, with measurable metastatic melanoma or other solid tumor, with at least one tumor deposit that is easily accessible to peri-tumoral DC injection. The preferred location is subcutaneous or intradermal. Patients with additional metastatic sites will not be excluded. Patients should have an expected survival of greater than three months.
- 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 B and C 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 solid tumors | 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 was stopped early (reason given: Because there were no responses). Results are not available in the source record.
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 solid tumors in people with Cancer of Skin and Solid Tumors, 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 13 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: stopped early, 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 was stopped early (reason given: Because there were no responses). 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?
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.