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A PHASE II TRIAL OF A VACCINE COMBINING MULTIPLE CLASS I PEPTIDES WITH MONTANIDE ISA 51 OR ISA 51 VG AND CpG ADJUVANT 7909 FOR PATIENTS WITH RESECTED STAGES IIC/III AND IV MELANOMA


Phase 2
16 Years
N/A
Not Enrolling
Both
Ciliary Body and Choroid Melanoma, Medium/Large Size, Ciliary Body and Choroid Melanoma, Small Size, Extraocular Extension Melanoma, Iris Melanoma, Metastatic Intraocular Melanoma, Mucosal Melanoma, Recurrent Intraocular Melanoma, Recurrent Melanoma, Stage IIC Melanoma, Stage IIIA Intraocular Melanoma, Stage IIIA Melanoma, Stage IIIB Intraocular Melanoma, Stage IIIB Melanoma, Stage IIIC Intraocular Melanoma, Stage IIIC Melanoma, Stage IV Intraocular Melanoma, Stage IV Melanoma

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Trial Information

A PHASE II TRIAL OF A VACCINE COMBINING MULTIPLE CLASS I PEPTIDES WITH MONTANIDE ISA 51 OR ISA 51 VG AND CpG ADJUVANT 7909 FOR PATIENTS WITH RESECTED STAGES IIC/III AND IV MELANOMA


PRIMARY OBJECTIVES I. To perform a two-cohort, two-stage phase II two cohort pilot trial of
a multi-peptide melanoma vaccine (multi-epitope melanoma peptide vaccine) with Montanide ISA
51 (incomplete Freund's adjuvant) or ISA 51 VG (Montanide ISA 51 VG) with adjuvant 7909
(agatolimod sodium) to define the safety and tolerability of each of the regimens, and to
evaluate immune reactivity to a tyrosinase/gp100/MAGE-3 class I peptide vaccine combined
with Montanide ISA 51 or ISA 51 VG with CpG adjuvant 7909 in human leukocyte antigen (HLA)
class I A1, A3 or A11 and B44 matched patients with surgically resected stages IIC, III and
IV melanoma.

OUTLINE: Patients are assigned to 1 of 2 treatment cohorts.

COHORT I: Patients receive multi-epitope peptide melanoma peptide vaccine with incomplete
Freund's adjuvant and agatolimod sodium subcutaneously (SC) at 0, 2, 4, 6, 8, 10, 14, 18,
22, 26, 38, and 50 weeks and then every six months for two years for up to 16 vaccinations
in the absence of disease progression or unacceptable toxicity.

COHORT II: Patients receive multi-epitope peptide melanoma peptide vaccine with Montanide
ISA 51 VG and agatolimod sodium SC at 0, 2, 4, 6, 8, 10, 14, 18, 22, 26, 38, and 50 weeks
and then every six months for two years for up to 16 vaccinations in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 3 years,
and then annually thereafter.


Inclusion Criteria:



- Stages IIC, III and IV cutaneous, or mucosal melanoma or stages III/IV ocular
melanoma that have been completely resected; those rendered disease-free by radiation
or systemic chemotherapy and/or immune therapy will also be eligible; patients must
be entered within 12 months of disease-free status

- Patients must be positive for at least one of human leukocyte antigen (HLA) A1,
A3/A11 typed by a standard deoxyribonucleic acid (DNA)-polymerase chain reaction
(PCR) assay, and HLA-B44 status must be known; patients who are B44 positive but do
not express A1, A3 or A11 are not eligible for this trial

- Tumor tissue must be available for analysis of gp100 and tyrosinase expression by
immunohistochemistry; positive staining for at least one antigen will be an
eligibility criteria for this trial

- Serum creatinine of 2.0 mg/dl or less

- Total bilirubin of 2.0 mg/dl or less

- Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamate pyruvate transaminase
(SGPT) of 2.5 X institutional norm or less

- Total white blood cell (WBC) of 3,000 or more

- At least 1500 granulocytes

- Hemoglobin of 9.0 gm/dl

- Platelet count of 100,000 per cu mm

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Patients will be eligible for this trial if they have failed alpha-interferon, if it
is felt to be contraindicated due to a pre-existing medical or psychiatric condition
or if they have refused treatment with it

- Ability to read, understand and willingness to sign an institutional review board
(IRB)-approved informed consent

Exclusion Criteria:

- Who are undergoing or have undergone in the past month any other therapy for their
cancer, including radiation therapy and adjuvant therapy; six weeks must have elapsed
for nitrosoureas

- Have major systemic infections like pneumonia or sepsis, coagulation or bleeding
disorders, or other major medical illnesses of the gastrointestinal, cardiovascular
or respiratory systems

- Who require steroid therapy or have been treated with steroids within 4 weeks of
starting the trial

- Who are pregnant or lactating, since the risk of autoimmune reactivity to tyrosinase
or gp100 is felt to present a risk to the fetus or a breast feeding infant

- Who are known to be positive for hepatitis B surface antigen (BsAg), Hepatitis C
antibody or human immunodeficiency virus (HIV) antibody; since cells removed for ex
vivo handling and tissue culture cannot be virus positive, and the effects of 7909
might be detrimental to HIV positive patients, patients positive for the above
viruses will not be treated on this trial

- Who have had a known allergic reaction to Montanide ISA 51 or ISA 51 VG

- Who have a prior history of uveitis, autoimmune inflammatory eye disease or other
autoimmune diseases other than vitiligo or controlled thyroiditis

- Who have had another malignancy within the last three years with the exception of
squamous or basal carcinoma of the skin or carcinoma in situ of the cervix that have
been treated with curative intent

- Who have previously received any of the peptides in the vaccine

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Immunologic response defined as either an enzyme-linked immunosorbent spot (ELISPOT) response or a tetramer response for at least one peptide

Outcome Time Frame:

26 weeks

Safety Issue:

No

Principal Investigator

Jeffrey Weber

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Southern California

Authority:

United States: Food and Drug Administration

Study ID:

10M-03-3

NCT ID:

NCT00085189

Start Date:

May 2004

Completion Date:

September 2007

Related Keywords:

  • Ciliary Body and Choroid Melanoma, Medium/Large Size
  • Ciliary Body and Choroid Melanoma, Small Size
  • Extraocular Extension Melanoma
  • Iris Melanoma
  • Metastatic Intraocular Melanoma
  • Mucosal Melanoma
  • Recurrent Intraocular Melanoma
  • Recurrent Melanoma
  • Stage IIC Melanoma
  • Stage IIIA Intraocular Melanoma
  • Stage IIIA Melanoma
  • Stage IIIB Intraocular Melanoma
  • Stage IIIB Melanoma
  • Stage IIIC Intraocular Melanoma
  • Stage IIIC Melanoma
  • Stage IV Intraocular Melanoma
  • Stage IV Melanoma
  • Melanoma
  • Uveal Neoplasms

Name

Location

University of Southern CaliforniaLos Angeles, California  90033