Inducing Systemic Immunity and Regressions in Metastatic Melanoma

Metastatic Malignant Melanoma Clinical Trial

Official title:

Inducing Systemic Immunity and Regressions in Metastatic Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02350972
• Other study ID #: S-1300774
• Status: Completed
• Phase: Phase 1
• First received: January 14, 2015
• Last updated: January 26, 2015
• Start date: July 1978
• Est. completion date: May 2002

Study information

• Verified date: January 2015
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board, "IRB New York University School of Medicine"
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: May 2002
• Est. primary completion date: May 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Melanoma
• Metastatic Malignant Melanoma

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune responses as evidenced by lymphocytic infiltrates in never-injected nodules.	The biopsies were examined by a licensed pathologist for the presence of dense lymphocytic infiltrates.	Cutaneous nodules were biopsied by a surgeon afer 8 to 20 weeks of injections.	No
Secondary	Complete regression of a metastasis	70 % of patients had at least one nodule regress. 40 % had all metastases completely regress for 5 to 20 years (median 60 months).	Complete regressions of all injected and never-injected metastases occurred in different pts after 13 weeks to 48 months of injections. Pts with progressive disease were switched to chemotherapy at any point in the study.	No