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Safety and Immunogenicity of Vaccination With Multi-Epitope Peptide Vaccine Containing MART-1, gp100, and Tyrosinase Peptides Given With the Combination of GMCSF and CpG Oligonucleotide (CpG 7909) in ISA-Oil Adjuvant for Patients With Recurrent Inoperable Stage III or Stage IV Melanoma


N/A
18 Years
N/A
Not Enrolling
Both
Intraocular Melanoma, Malignant Conjunctival Neoplasm, Melanoma (Skin)

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Trial Information

Safety and Immunogenicity of Vaccination With Multi-Epitope Peptide Vaccine Containing MART-1, gp100, and Tyrosinase Peptides Given With the Combination of GMCSF and CpG Oligonucleotide (CpG 7909) in ISA-Oil Adjuvant for Patients With Recurrent Inoperable Stage III or Stage IV Melanoma


OBJECTIVES:

- Determine the safety of a peptide vaccine comprising MART-1:27-35 peptide,
gp100:209-217 (210M) peptide, and tyrosinase peptide with sargramostim (GM-CSF) and CpG
7909 emulsified in incomplete Freund's adjuvant in patients with unresectable recurrent
stage III or IV melanoma.

- Determine the efficacy of immunoadjuvants CpG 7909 and GM-CSF, in terms of a strong
antigen-specific CD8+ T-cell response, in these patients.

- Determine the anti-pigmentary response to this regimen in these patients.

- Determine the anti-tumor response, in terms of objective tumor regression,
progression-free survival, and overall survival, in patients treated with this regimen.

OUTLINE: This is a pilot study.

Patients receive peptide vaccine comprising MART-1:27-35 peptide, gp100:209-217 (210M)
peptide, and tyrosinase peptide with sargramostim (GM-CSF) and CpG 7909 emulsified in
incomplete Freund's adjuvant subcutaneously on days 1 and 15. Treatment repeats every 28
days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline, day 50-53, and day 91-94. Samples are examined by
ELISPOT assay to measure lymphocyte immune response and by flow cytometry for biomarker
quantification and T-cell response.

After completion of study treatment, patients are followed up periodically for at least 2
years.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed melanoma meeting the following criteria:

- Unresectable recurrent disease

- Stage III or IV disease

- Cutaneous, ocular, or mucosal melanoma

- Measurable disease as defined by the RECIST criteria

- HLA-A2 positive

- Prior brain metastases allowed provided adequate surgical or radiologic treatment for
brain disease

PATIENT CHARACTERISTICS:

- ECOG performance status 0 or 1

- WBC ≥ 3,000/mm³

- Lymphocytes ≥ 1,000/mm³

- Platelet count ≥ 100,000/mm³

- Creatinine ≤ 1.5 times upper limit of normal (ULN)

- Bilirubin ≤ 1.5 times ULN

- AST and ALT ≤ 2.5 times ULN

- Lactic dehydrogenase ≤ 2.0 times ULN

- aPTT < 40 seconds

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception for ≥ 1 week before, during, and
for ≥ 2 weeks after completion of study therapy

- No conditions of immunosuppression

- Negative titers for antinuclear antibody (≤ 1/80) and antidouble stranded DNA (≤
1/10)

- No serious illnesses including, but not limited to, any of the following:

- Bleeding disorders

- Autoimmune diseases

- Severe obstructive or restrictive pulmonary diseases

- Active systemic infections

- Inflammatory bowel disorders

- No serious cardiovascular disease including, but not limited to, any of the
following:

- Uncontrolled congestive heart failure

- Hypertension

- Cardiac ischemia

- Myocardial infarction,

- Severe cardiac arrhythmia

- HIV1 and 2 negative

- HTLV-1 negative

- Hepatitis B and C negative

- No significant psychiatric disease, medical intervention, or other condition that, in
the opinion of the principal investigator, would limit study compliance

- No active infection within the past week, including unexplained fever (temperature >
38.1°C)

PRIOR CONCURRENT THERAPY:

- Fully recovered from prior major surgery

- More than 4 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas),
hormonal therapy, radiotherapy, or biological therapy

- More than 1 week since prior antibiotics

- More than 28 days since prior investigational agent

- No prior vaccination with MART-1 (26-35, 27L), gp100 (209-217, 210M), and tyrosinase
(368-376, 370D) peptides alone or in combination

- Patients with history of vaccination with peptides other than MART-1 (26-35,
27L), gp100 (209-217, 210M), and tyrosinase (368-376, 370D) peptides allowed

- More than 4 weeks since prior and no concurrent systemic immunosuppressive therapy,
including steroids

- Patients on maintenance steroids given at physiologic doses because of adrenal
insufficiency are eligible

- More than 2 weeks since prior and no concurrent treatment with systemic steroids,
including oral steroids, continuous use of topical steroid creams or ointments, or
any inhaled steroids

- No concurrent anticoagulants, except to keep an indwelling line patent

- No other concurrent anticancer therapy, including chemotherapy, immunotherapy,
radiotherapy, experimental programs, and/or surgery

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Safety Issue:

Yes

Principal Investigator

Ahmad A. Tarhini, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000544402

NCT ID:

NCT00471471

Start Date:

October 2008

Completion Date:

Related Keywords:

  • Intraocular Melanoma
  • Malignant Conjunctival Neoplasm
  • Melanoma (Skin)
  • recurrent melanoma
  • stage IV melanoma
  • ciliary body and choroid melanoma, medium/large size
  • extraocular extension melanoma
  • iris melanoma
  • recurrent intraocular melanoma
  • metastatic intraocular melanoma
  • conjunctival melanoma
  • stage IIIA melanoma
  • stage IIIB melanoma
  • stage IIIC melanoma
  • Neoplasms
  • Conjunctival Neoplasms
  • Melanoma
  • Uveal Neoplasms

Name

Location

UPMC Cancer CentersPittsburgh, Pennsylvania  15232