Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma (NCT00398073) | Clinical Trial Compass
CompletedPhase 1
Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma
United States35 participantsStarted 2006-10
Plain-language summary
RATIONALE: Vaccines made from DNA may help the body build an effective immune response to kill tumor cells. Giving the vaccine in different ways may make a stronger immune response and kill more tumor cells.
PURPOSE: This randomized clinical trial is studying two different ways of giving vaccine therapy to compare how well they work in treating patients with stage IIB, stage IIC, stage III, or stage IV melanoma.
Who can participate
Age range1 Year – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed malignant melanoma
* Stage IIB, IIC, III, or IV disease
* Patients free of disease after surgical resection must meet 1 of the following criteria:
* Refused high-dose interferon alfa
* Recurrence while on interferon alfa
* Patients with stage IIB, IIC, or III disease must have already undergone initial standard therapy (i.e., surgery) for the disease
* Choroidal (uveal) melanoma allowed provided 1 of the following criteria is met:
* Basal diameter \> 16 mm
* Basal height \> 8 mm
* Involvement of the ciliary body with tumor
* HLA-A\*0201 positive
* Negative serum antidouble-stranded DNA antibody screen
* No known brain metastases
PATIENT CHARACTERISTICS:
* Karnofsky performance status 80-100%
* Platelet count ≥ 100,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* WBC ≥ 3,000/mm\^3
* Lactic dehydrogenase ≤ 2 times upper limit of normal (ULN)
* Creatinine ≤ 2.0 mg/dL
* Bilirubin ≤ 2.5 times ULN
* Albumin ≥ 3.5 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Weight ≥ 25 kg
* No preexisting choroidal eye disease
* No serious underlying medical conditions that could be exacerbated by study participation (i.e., active infections requiring antimicrobial drugs or active bleeding)
* No allergy to gold (i.e., gold jewelry)
* No evidence of any condition at the proposed site(s) of vaccine administration that might interfere with the i…
What they're measuring
1
Number of Patients Evulated for Toxicity and Safety