|Toxiciy Grade:||5||City/State/Province:||El Paso, TX|
|Treatments:||Immunotherapy||Hospital:||University of El Paso|
Patients: This trial involved 604 patients with resected stage III cutaneous melanoma. These patients were mostly men (66%), and 96-99% were white. The average age was 48.5 years.
Treatment: Patients were divided into two study arms. Arm 1 received immunotherapy with an allogeneic melanoma lysate vaccine (Melacine) and low-dose interferon alpha. Arm 2 received a high dose of interferon alpha and no vaccine.
Toxicity: Grade 3 and 4 toxicities included anorexia, diarrhea, elevated liver enzymes, fatigue, neuropsychiatric symptoms, thrombocytopenia, and weight loss. One patient in arm 1 committed suicide. Depression, impotency, a seizure suicide attempt, delusions, severe confusion, severe mental change status, a psychotic break, and short term memory loss were also reported in 6 or fewer patients in arm 2.
Results: The median overall survival was 83 months in arm 2, and was not reached within 84 months in arm 1 (that is, many patients were still alive at this time and overall survival could not be calculated).
Support: This study was supported by Integrated Therapeutics, Schering-Plough, which markets interferon alpha-2b as INTRON“ A.
Correspondence: Dr. Malcolm Mitchell