Vaccination With Multiple Synthetic Melanoma Peptides Recognized by Helper T-Cells in Patients With Advanced Melanoma
18 Years
N/A
Both
Intraocular Melanoma, Melanoma (Skin)
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 Center | Charlottesville, Virginia 22908 |
