Vaccine Therapy in Treating Patients With Advanced Melanoma (NCT00705640) | Clinical Trial Compass
CompletedPhase 1
Vaccine Therapy in Treating Patients With Advanced Melanoma
United States45 participantsStarted 2008-05
Plain-language summary
RATIONALE: Vaccine therapy may help the body build an effective immune response to kill tumor cells.
PURPOSE: This randomized clinical trial is studying how well vaccine therapy works in treating patients with advanced melanoma.
Who can participate
Age range18 Years – 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 or cytologically confirmed melanoma that meets one of the following criteria:
* Stage IIB-IV melanoma rendered clinically free of disease by surgery, other therapy, or spontaneous remission within the past 6 months
* Stage III or IV melanoma with disease
* Persistent or metastatic disease allowed if RECIST criteria for measurable disease is not met
* Multiple primary melanomas allowed
* Prior or concurrent metastasis from a cutaneous, mucosal, ocular, or unknown primary site allowed
* No clinically detectable melanoma deemed likely by the investigator to require intervention during the first 12 weeks of the study that would require premature discontinuation (e.g., untreated bone metastases at risk for fracture or rapidly progressive low-volume disease)
* Brain metastases allowed if all of the following criteria are met:
* The total number of brain metastases ever is ≤ 3
* The brain metastases have been completely removed by surgery or have been treated completely by stereotactic radiotherapy
* There has been no evident growth of any brain metastasis since treatment
* No treated brain metastasis \> 2 cm in diameter
* At least two intact axillary and/or inguinal lymph node basins
* Prior lymph node biopsy allowed if lymphoscintigraphy demonstrates intact drainage to a node in that basin
* If a sentinal lymph node is not located by lymphoscintigraphy, patient is not eligible for study
* HLA-A1, -A2, -A3, or -A11 positiv…
What they're measuring
1
Features of lymphoid neogenesis at the replicate immunization site