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Vaccination With Multiple Synthetic Melanoma Peptides Recognized by Helper T-Cells in Patients With Advanced Melanoma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Intraocular Melanoma, Melanoma (Skin)

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Trial Information

Vaccination With Multiple Synthetic Melanoma Peptides Recognized by Helper T-Cells in Patients With Advanced Melanoma


OBJECTIVES:

- Determine the immune response in patients with stage IIIB, IIIC, or IV melanoma treated
with vaccine comprising multiple synthetic melanoma peptides, Montanide ISA-51, and
sargramostim (GM-CSF).

OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.

- Arm I: Patients receive vaccine comprising low-dose multiple synthetic melanoma
peptides, Montanide ISA-51, and sargramostim (GM-CSF) on days 1, 8, 15, 29, 36, and 43.

- Arm II: Patients receive vaccine comprising medium-dose multiple synthetic melanoma
peptides, Montanide ISA-51, and GM-CSF as in arm I.

- Arm III: Patients receive vaccine comprising high-dose multiple synthetic melanoma
peptides, Montanide ISA-51, and GM-CSF as in arm I.

On day 22, the lymph node draining the vaccination site is removed to determine whether the
immune system is responding to the vaccine.

PROJECTED ACCRUAL: A maximum of 38 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of stage IIIB, IIIC, or IV melanoma

- HLA-DR1, -DR4, -DR11, -DR13, or -DR15 positive

- Brain metastases allowed at the discretion of the principle investigator

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count > 1,000/mm^3

- Platelet count > 100,000/mm ^3

- Hemoglobin > 9 g/dL

Hepatic

- Liver function tests ≤ 2.5 times upper limit of normal (ULN)

Renal

- Creatinine ≤ 1.5 times ULN

Cardiovascular

- No New York Heart Association class III or IV heart disease

Other

- Prior diagnosis of other cancer allowed

- Not pregnant or nursing

- Weight ≥ 110 pounds

- No uncontrolled diabetes

PRIOR CONCURRENT THERAPY:

Biologic therapy

- More than 4 weeks since prior growth factors

- More than 4 weeks since prior allergy shots

- More than 12 weeks since prior melanoma vaccine therapy* NOTE: *Prior melanoma
vaccine allowed only for patients with disease progression during or after
administration of the vaccine

- No prior vaccination with any of the peptides used in this study

Chemotherapy

- More than 4 weeks since prior chemotherapy

Endocrine therapy

- More than 4 weeks since prior steroids

Radiotherapy

- More than 4 weeks since prior radiotherapy

Surgery

- Not specified

Other

- More than 1 month since prior investigational drugs or therapies

- No other concurrent investigational drugs or therapies

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety if less than 33% of patients experience a dose-limiting toxicity at day 22

Safety Issue:

Yes

Principal Investigator

Craig L. Slingluff, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Virginia

Authority:

United States: Federal Government

Study ID:

CDR0000378171

NCT ID:

NCT00089219

Start Date:

July 2003

Completion Date:

Related Keywords:

  • Intraocular Melanoma
  • Melanoma (Skin)
  • stage III melanoma
  • stage IV melanoma
  • recurrent melanoma
  • ciliary body and choroid melanoma, medium/large size
  • extraocular extension melanoma
  • iris melanoma
  • recurrent intraocular melanoma
  • Melanoma
  • Uveal Neoplasms

Name

Location

University of Virginia Cancer CenterCharlottesville, Virginia  22908