Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed B… (NCT00089206) | Clinical Trial Compass
CompletedPhase 2
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery
United States7 participantsStarted 2002-08
Plain-language summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery.
Who can participate
Age range12 Years
SexALL
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DISEASE CHARACTERISTICS:
* Diagnosis of melanoma
* Unresectable stage III or IV disease
* Mucosal or ocular disease allowed
* Positive HLA-A1, -A2, or -A3 expression
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
* Weight ≥ 100 pounds
* Not pregnant or nursing
* No other malignancy within the past 5 years except squamous cell or basal cell skin cancer without known metastasis, carcinoma in situ of the breast, or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior vaccination with any of the peptides used in this protocol
* More than 1 year since prior melanoma vaccine therapy
* More than 4 weeks since prior immunotherapy
* More than 4 weeks since prior growth factors
* More than 4 weeks since prior allergy shots
Chemotherapy
* More than 4 weeks since prior chemotherapy
Endocrine therapy
* More than 4 weeks since prior steroid therapy
Radiotherapy
* More than 4 weeks since prior radiotherapy
Surgery
* Prior tumor resection allowed