Official Title
Inducing Systemic Immunity and Regressions in Metastatic Melanoma
Phase
Phase 1Lead Sponsor
New York UniversityStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Metastatic Malignant MelanomaIntervention/Treatment
autologous cytokines ...Study Participants
88In patients with multiple metastatic nodules of melanoma, the investigators evaluated whether autologous cytokines injected into cutaneous metastases would induce a systemic immune response as evidenced by the accumulation of dense lymphocytic infiltrates in metastases that had never been injected. Such immune responses were observed, and often the never-injected metastasis regressed completely. 20% of patients remained free of disease for greater than 5 years.
Lymphocytic infiltrates were seen in never-injected nodules only after several weeks of injections elsewhere. No adverse events were seen. The tumor-infiltrating lymphocytes were able to kill autologous melanoma ex vivo. Some patients who experienced complete regressions of all metastases lived without disease for over 10 years.
Sterile autologous cytokines were injected weekly into multiple metastatic nodules while other nodules in the patient were never injected and were monitored for the development of dense lymphocytic infiltrates as evidence of an induced immune response.
Autologous cytokines obtained from patients' blood mononuclear cells injected in volumes of 0.1 ml
Inclusion Criteria: Multiple cutaneous or subcutaneous metastases of melanoma Exclusion Criteria: Visceral metastases on admission. No current chemotherapy or immunotherapy. Note study performed between 1978 and 2002 before current therapies were available.
