Vaccine Therapy in Treating Patients With Primary Stage II Melanoma (NCT00005052) | Clinical Trial Compass
UnknownPhase 3
Vaccine Therapy in Treating Patients With Primary Stage II Melanoma
Australia, BelgiumStarted 1999-12
Plain-language summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether vaccine therapy is more effective than observation alone for melanoma.
PURPOSE: This randomized phase III trial is studying vaccine therapy to see how well it works compared to observation alone in treating patients with primary stage II melanoma.
Who can participate
Age range18 Years – 80 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 primary stage II melanoma greater than 1.5 mm without evidence of lymph node metastases
* T3 or T4, N0, M0
* Must originate in the skin
* Wide excision with a minimum of 1-2 cm margin surrounding primary lesion or biopsy scar
* No more than 56 days since definitive surgical treatment (wide excision)
* No more than 12 weeks since primary surgery
* No clinical, radiological, or pathological evidence of incompletely resected disease, lymph node metastases, in-transit metastasis, or any distant metastatic disease
PATIENT CHARACTERISTICS:
Age:
* 18 to 80
Performance status:
* ECOG 0-1
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9.8 g/dL
Hepatic:
* SGOT/SGPT no greater than 2 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 2 times ULN
* LDH no greater than 2 times ULN
* Bilirubin no greater than 2 times ULN
* Hepatitis B and C negative
Renal:
* Creatinine normal
Other:
* Not pregnant or nursing
* Negative pregnancy test
* No prior or other concurrent cancer except carcinoma in situ of the cervix or basal or squamous cell skin cancer
* No autoimmune disorders
* No conditions requiring systemic treatment with immunosuppressive drugs including treatment with systemic corticosteroids
* No history of CNS demyelinating or inflammatory disease
* No hereditary or acquired peripheral neuropathy
* N…
What they're measuring
1
Disease-free survival
Trial details
NCT IDNCT00005052
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC