Inducing Systemic Immunity and Regressions in Metastatic Melanoma

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Malignant Melanoma
• Intervention / Treatment: Biological: Autologous cytokines

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autologous cytokiines; Autologous cytokines obtained from patients' blood mononuclear cells injected in volumes of 0.1 ml	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.; Other Names: cytokine/chemokine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Fred T. Valentine, M.D., NYU Langone Health

Study record dates

Study Major Dates

• Study Start: July 1, 1978
• Primary Completion (Actual): May 1, 2002
• Study Completion (Actual): May 1, 2002

Study Registration Dates

• First Submitted: January 14, 2015
• First Submitted That Met QC Criteria: January 26, 2015
• First Posted (Estimate): January 30, 2015

Study Record Updates

• Last Update Posted (Estimate): January 30, 2015
• Last Update Submitted That Met QC Criteria: January 26, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: S-1300774