MelanomaPhase 1NCT01783431
Study of Vaccination With Poly-ICLC and Peptide-pulsed Dendritic Cells
A Phase 1 study testing Poly ICLC and leukapheresis in people with Melanoma, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This study is for subjects with a type of skin cancer called melanoma. The main purpose of this study is to examine the safety of the study drug (Poly-ICLC) in patients with your disease. The study team would like to know about any side effects a patient may have when given the study drug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Poly ICLC and leukapheresis
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Nov 2013
- 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
- Patients must have histologically or cytologically confirmed diagnosis of melanoma that is metastatic and/or unresectable. If the histologic diagnosis is based on a metastatic site, the histology must be compatible with melanoma.
- Patients must be HLA-A2 positivity by serological testing.
- Patients must have measurable disease per RECIST 1.1
- Patients may have had prior cancer therapy. Patients do not need to demonstrate progression to be considered for this trial.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Age ≥ 18 years.
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- Patient must have an expected life expectancy greater than 3 months.
- Signed, written IRB-approved informed consent.
- Acceptable organ function:
- Bilirubin ≤ 3 times upper limit of normal (CTCAE Grade 2 baseline)
- AST (SGOT), ALT (SGPT) ≤ 3 x ULN (CTCAE Grade 1 baseline)
- Serum creatinine ≤1.5 XULN (CTCAE Grade 1 baseline)
- Acceptable hematologic status:
- Absolute neutrophil count ≥ 1000 cells/mm3,
- Platelet count ≥ 75,000 (plt/mm3), (CTCAE Grade 1 baseline)
- Hemoglobin ≥ 9 g/dL.
- Urinalysis with no clinically significant abnormalities.
- PT and PTT ≤ 1.5 X ULN after correction of nutritional deficiencies that may contribute to prolonged PT/PTT.
Who cannot join
- Patients must not have any serious uncontrolled acute or chronic medical condition that would interfere with this treatment. Examples would include active acute or chronic infection requiring antibiotics, uncontrolled cardiovascular, endocrine, or infectious disease.
- Patients must not have significant ongoing cardiac problems, myocardial infarction within the last six months, uncontrolled hypertension, unstable angina, uncontrolled arrhythmia or congestive heart failure.
- Surgery less than or equal to 14 days prior to study registration
- Patients who have had prior radiation or chemotherapy in which the last treatment administration is less than or equal to 28 days prior to registration. Patients who have had prior treatment with ipilimumab or Interleukin-2 will be allowed as long as this 28 day wash-out period is followed.
- Patients who are breast feeding or have a positive pregnancy test (if female).
- Patients with active CNS lesions are excluded (i.e., those with radiographically unstable, symptomatic lesions). However, a patient treated with stereotactic therapy or surgery is eligible if the patient remains without evidence of disease progression in the brain and is stable for 1 month. Whole brain radiotherapy is not allowed, with the exception of patients who have had definitive resection or stereotactic therapy of all radiologically detectable parenchymal lesions.
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- Patients must have no plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy or any other type of therapy for treatment of cancer while on this protocol treatment.
- Due to the undetermined effect of this treatment regimen in patients with HIV-1 infection and the potential for serious interaction with anti-HIV medications, patients known to be infected with HIV are not eligible for this study.
- Due to the possibility of harm to a fetus or nursing infant from this treatment regimen, patients must not be pregnant or nursing. Women and men of reproductive potential must have agreed to use an effective contraceptive method.
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: A Feasibility and Safety Study of Vaccination With Poly-ICLC and Peptide-pulsed Dendritic Cells in Patients With Metastatic and/or Unresectable Melanoma
This study is for subjects with a type of skin cancer called melanoma. The main purpose of this study is to examine the safety of the study drug (Poly-ICLC) in patients with your disease. The study team would like to know about any side effects a patient may have when given the study drug. Another goal of the study is to determine if combining dendritic cells and the study drug can be possibly used as a vaccine for your disease.
Read the detailed description
Dendritic cells are cells that are present in your body's immune system that help your body fight disease. This is a vaccine trial, as your own cells will be extracted (removed), treated in a lab, then re-administered to your body with the study drug in hopes of creating an immune response to the disease. It is not guaranteed that your disease burden will be reduced by participating in this trial.TScreening tests will be conducted to determine whether or not subjects can participate in this study. If subjects are eligible and choose to participate, they will have a procedure called leukapheresis. The leukapheresis product that is collected from you will be taken to a special lab at MUSC where it will undergo a process that will grow additional dendritic cells under controlled conditions in the lab. These cells will be given together with Poly-ICLC therapy when you begin study treatment. Some days you will receive both Poly-ICLC and dendritic cells, but on other days you will receive the Poly-ICLC by itself. After study treatment, subjects may be asked to return to MUSC approximately every 3 months for the first 2 years, then every 6 months thereafter for follow up procedures.
- Conditions
- Melanoma
- Being tested
- Poly ICLC, leukapheresis
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poly ICLCDrug
Poly-ICLC is considered an investigational drug and has not been approved by the Food and Drug Administration (FDA) for treatment of your disease. It is currently being tested in clinical trials for brain tumors, lymphoma, human immunodeficiency virus (HIV) and prostate cancer. It is thought that Poly-ICLC, when used with dendritic cells as a vaccine therapy, may work to help the immune system fight disease.
leukapheresisProcedure or surgery
Leukapheresis is a process in which white blood cells are collected from the body. These cells will be given together with Poly-ICLC therapy when subjects begin study treatment.
| Study group | Role | What they receive |
|---|---|---|
| Leukapheresis and Poly-ICLC | Experimental | Screening tests will be conducted to determine whether or not subjects can participate in this study. If subjects are eligible and choose to participate, they will have a procedure called leukapheresis. The leukapheresis product that is collected from you will be taken to a special lab at MUSC where it will undergo a process that will grow additional dendritic cells under controlled conditions in the lab. These cells will be given together with Poly-ICLC therapy when you begin study treatment. Some days you will receive both Poly-ICLC and dendritic cells, but on other days you will receive the Poly-ICLC by itself. After study treatment, subjects may be asked to return to MUSC approximately every 3 months for the first 2 years, then every 6 months thereafter for follow up procedures. Receives: Drug: Poly ICLC; Procedure: leukapheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
- safety of this treatment by evaluating the qualitative and quantitative toxicities in this group of patients through adverse event reporting
Measured: 2 years
Secondary outcomes (3)
Feasibility
- feasibility of generating dendritic cells and administering these cells as a vaccine to patients
Measured: 2 years
Anti-tumor Response
anti-tumor response after vaccination, measured by changes in tumor burden and overall survival
Measured: 2 years
Immunological Responses
- immunological responses after vaccination (antigen-specific T cell cytokine production, antigen-specific T cell frequencies by tetramer analysis, and DTH reactions)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startOct 2012
- Primary completionJul 2013
- Study completionNov 2013
Why it stopped: The study was terminated early due to low accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keisuke Shirai, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783431
- Sponsor's protocol ID
- 101838
- Status last verified
- May 2014
- First submitted
- 25 Jan 2013
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility and Safety Study of Vaccination With Poly-ICLC and Peptide-pulsed Dendritic Cells in Patients With Metastatic and/or Unresectable Melanoma
- ClinicalTrials.gov ID
- NCT01783431
- Acronym / sponsor ID
- 101838
- Conditions
- Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to low accrual.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 4 Feb 2013 (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.
This study is for subjects with a type of skin cancer called melanoma. The main purpose of this study is to examine the safety of the study drug (Poly-ICLC) in patients with your disease. The study team would like to know about any side effects a patient may have when given the study drug. Another goal of the study is to determine if combining dendritic cells and the study drug can be possibly used as a vaccine for your disease.
Detailed description
Dendritic cells are cells that are present in your body's immune system that help your body fight disease. This is a vaccine trial, as your own cells will be extracted (removed), treated in a lab, then re-administered to your body with the study drug in hopes of creating an immune response to the disease. It is not guaranteed that your disease burden will be reduced by participating in this trial.TScreening tests will be conducted to determine whether or not subjects can participate in this study. If subjects are eligible and choose to participate, they will have a procedure called leukapheresis. The leukapheresis product that is collected from you will be taken to a special lab at MUSC where it will undergo a process that will grow additional dendritic cells under controlled conditions in the lab. These cells will be given together with Poly-ICLC therapy when you begin study treatment. Some days you will receive both Poly-ICLC and dendritic cells, but on other days you will receive the Poly-ICLC by itself. After study treatment, subjects may be asked to return to MUSC approximately every 3 months for the first 2 years, then every 6 months thereafter for follow up procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Leukapheresis and Poly-ICLC | Experimental | Drug: Poly ICLC, Procedure: leukapheresisScreening tests will be conducted to determine whether or not subjects can participate in this study. If subjects are eligible and choose to participate, they will have a procedure called leukapheresis. The leukapheresis product that is collected from you will be taken to a special lab at MUSC where it will undergo a process that will grow additional dendritic cells under controlled conditions in the lab. These cells will be given together with Poly-ICLC therapy when you begin study treatment. Some days you will receive both Poly-ICLC and dendritic cells, but on other days you will receive the Poly-ICLC by itself. After study treatment, subjects may be asked to return to MUSC approximately every 3 months for the first 2 years, then every 6 months thereafter for follow up procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients must have histologically or cytologically confirmed diagnosis of melanoma that is metastatic and/or unresectable. If the histologic diagnosis is based on a metastatic site, the histology must be compatible with melanoma.
- Patients must be HLA-A2 positivity by serological testing.
- Patients must have measurable disease per RECIST 1.1
- Patients may have had prior cancer therapy. Patients do not need to demonstrate progression to be considered for this trial.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
Key exclusion criteria (10 listed)
- Patients must not have any serious uncontrolled acute or chronic medical condition that would interfere with this treatment. Examples would include active acute or chronic infection requiring antibiotics, uncontrolled cardiovascular, endocrine, or infectious disease.
- Patients must not have significant ongoing cardiac problems, myocardial infarction within the last six months, uncontrolled hypertension, unstable angina, uncontrolled arrhythmia or congestive heart failure.
- Surgery less than or equal to 14 days prior to study registration
- Patients who have had prior radiation or chemotherapy in which the last treatment administration is less than or equal to 28 days prior to registration. Patients who have had prior treatment with ipilimumab or Interleukin-2 will be allowed as long as this 28 day wash-out period is followed.
- Patients who are breast feeding or have a positive pregnancy test (if female).
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 |
|---|---|---|
| Poly ICLCPoly-ICLC is considered an investigational drug and has not been approved by the Food and Drug Administration (FDA) for treatment of your disease. It is currently being tested in clinical trials for brain tumors, lymphoma, human immunodeficiency virus (HIV) and prostate cancer. It is thought that Poly-ICLC, when used with dendritic cells as a vaccine therapy, may work to help the immune system fight disease. | Drug | Leukapheresis and Poly-ICLC |
| leukapheresisLeukapheresis is a process in which white blood cells are collected from the body. These cells will be given together with Poly-ICLC therapy when subjects begin study treatment. | Procedure or surgery | Leukapheresis and Poly-ICLC |
Primary outcome
Safety
Time frame: 2 years
- safety of this treatment by evaluating the qualitative and quantitative toxicities in this group of patients through adverse event reporting
3 secondary outcomes
Feasibility
Time frame: 2 years
Anti-tumor Response
Time frame: 2 years
Immunological Responses
Time frame: 2 years
Results and safety
The study was stopped early (reason given: The study was terminated early due to low accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 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.
Keisuke Shirai, MD principal investigator
Medical University of South Carolina
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 Poly ICLC and leukapheresis in people with Melanoma, run by Medical University of South Carolina at 1 site in United States.
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 10 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 2 Oct 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 United States. 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 was stopped early (reason given: The study was terminated early due to low accrual.). 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 (time frame: 2 years). 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 2 Oct 2015.