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A Feasibility and Safety Study of Vaccination With Poly-ICLC and Peptide-pulsed Dendritic Cells in Patients With Metastatic and/or Unresectable Melanoma

18 Years
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Trial Information

A Feasibility and Safety Study of Vaccination With Poly-ICLC and Peptide-pulsed Dendritic Cells in Patients With Metastatic and/or Unresectable Melanoma

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.

Inclusion Criteria:

- 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.

- 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.

Exclusion Criteria:

- 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.

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

- safety of this treatment by evaluating the qualitative and quantitative toxicities in this group of patients through adverse event reporting

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Keisuke Shirai, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of South Carolina


United States: Food and Drug Administration

Study ID:




Start Date:

October 2012

Completion Date:

October 2014

Related Keywords:

  • Melanoma
  • Melanoma



Medical University of South CarolinaCharleston, South Carolina  29425-0721