Evaluation of GM-CSF-in-Adjuvant and the Number of Vaccine Sites on Immunization With Multiple Synthetic Melanoma Peptides
12 Years
N/A
Both
Melanoma (Skin)
Trial Information
Evaluation of GM-CSF-in-Adjuvant and the Number of Vaccine Sites on Immunization With Multiple Synthetic Melanoma Peptides
OBJECTIVES:
- Compare immune response in patients with stage IIB-IV melanoma treated with vaccination
comprising multiple synthetic melanoma peptides and Montanide ISA-51 with vs without
sargramostim (GM-CSF).
- Compare immune response in patients treated with these vaccinations administered at 1
vs 2 sites.
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 4 treatment
arms.
- Arm I: Patients receive vaccination comprising multiple synthetic melanoma peptides and
Montanide ISA-51 at 1 injection site.
- Arm II: Patients receive vaccination comprising multiple synthetic melanoma peptides
and Montanide ISA-51 at 2 injection sites.
- Arm III: Patients receive vaccination comprising multiple synthetic melanoma peptides,
Montanide ISA-51, and sargramostim (GM-CSF) at 1 injection site.
- Arm IV: Patients receive vaccination comprising multiple synthetic melanoma peptides,
Montanide ISA-51, and GM-CSF at 2 injection sites.
In all arms, treatment repeats once weekly for 6 weeks. Patients return for booster
vaccinations at weeks 12, 26, 39, and 52.
PROJECTED ACCRUAL: A maximum of 124 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of melanoma
- Stage IIB, IIC, III, or IV disease
- Must express HLA-A1, -A2, or -A3
- No ocular melanoma
PATIENT CHARACTERISTICS:
Age
- 12 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
- Not pregnant or nursing
- No other malignancy within the past 5 years except basal cell or squamous cell skin
cancer without brain metastasis, carcinoma in situ of the breast, or carcinoma in
situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 4 weeks since prior immunotherapy
- More than 4 weeks since prior growth factors
- More than 4 weeks since prior allergy shots
- No prior vaccine therapy for melanoma or any other cancer with any of the peptides
used in this study
- 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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Craig L. Slingluff, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Virginia
Authority:
United States: Federal Government
Study ID:
CDR0000378169
NCT ID:
NCT00089193
Start Date:
September 2003
Completion Date:
Related Keywords:
- Melanoma (Skin)
- stage II melanoma
- stage III melanoma
- stage IV melanoma
- recurrent melanoma
- Melanoma
Name | Location |
|---|---|
| Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
| Cancer Center at the University of Virginia | Charlottesville, Virginia 22908 |
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15236 |
| Washington Cancer Institute at Washington Hospital Center | Washington, District of Columbia 20010 |
| MD Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
