Melanoma Clinical Trial
Vaccine Therapy in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma
Summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: This randomized phase I/II trial is studying three different doses of a vaccine and comparing them to see how well they work in treating patients with stage IIIB, stage IIIC, or stage IV melanoma.
Full Description
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.
Eligibility 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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Charlottesville Virginia, 22908, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.