NCT02350972

Inducing Systemic Immunity and Regressions in Metastatic Melanoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

In 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.

Detailed description

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.

Conditions

• Metastatic Malignant Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Autologous cytokines	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.

Timeline

• Start date: 1978-07-01
• Primary completion: 2002-05-01
• Completion: 2002-05-01
• First posted: 2015-01-30
• Last updated: 2015-01-30