Vaccine Therapy in Treating Patients With Recurrent Stage III or Stage IV Melanoma That Cannot Be… (NCT00471471) | Clinical Trial Compass
CompletedPhase 1
Vaccine Therapy in Treating Patients With Recurrent Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
United States22 participantsStarted 2008-10
Plain-language summary
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with GM-CSF, CpG 7909, and incomplete Freund's adjuvant may make a stronger immune response and kill more tumor cells.
PURPOSE: This clinical trial is studying the side effects and how well vaccine therapy works in treating patients with recurrent stage III or stage IV melanoma that cannot be removed by surgery.
Who can participate
Age range18 Years
SexALL
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DISEASE CHARACTERISTICS:
* Histologically confirmed melanoma meeting the following criteria:
* Unresectable recurrent disease
* Stage III or IV disease
* Cutaneous, ocular, or mucosal melanoma
* Measurable disease as defined by the RECIST criteria
* HLA-A2 positive
* Prior brain metastases allowed provided adequate surgical or radiologic treatment for brain disease
PATIENT CHARACTERISTICS:
* ECOG performance status 0 or 1
* WBC ≥ 3,000/mm³
* Lymphocytes ≥ 1,000/mm³
* Platelet count ≥ 100,000/mm³
* Creatinine ≤ 1.5 times upper limit of normal (ULN)
* Bilirubin ≤ 1.5 times ULN
* AST and ALT ≤ 2.5 times ULN
* Lactic dehydrogenase ≤ 2.0 times ULN
* aPTT \< 40 seconds
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception for ≥ 1 week before, during, and for ≥ 2 weeks after completion of study therapy
* No conditions of immunosuppression
* Negative titers for antinuclear antibody (≤ 1/80) and antidouble stranded DNA (≤ 1/10)
* No serious illnesses including, but not limited to, any of the following:
* Bleeding disorders
* Autoimmune diseases
* Severe obstructive or restrictive pulmonary diseases
* Active systemic infections
* Inflammatory bowel disorders
* No serious cardiovascular disease including, but not limited to, any of the following:
* Uncontrolled congestive heart failure
* Hypertension
* Cardiac ischemia
* Myocardial infarction,
* Severe cardiac arrhythmia
* HIV1 and 2 negative
* HTLV-1 nega…