Inducing Systemic Immunity and Regressions in Metastatic Melanoma

Phase 1

Completed

• Conditions: Metastatic Malignant Melanoma
• Interventions: Biological: Autologous cytokines

• Registration Number: NCT02350972
• Lead Sponsor: NYU Langone Health

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 1978-07
• Primary Completion: 2002-05
• Study Completion: 2002-05
• Status Verified: 2015-01
• Study First Submitted: 2015-01-14
• Study First Submitted QC: 2015-01-26
• Last Update Submitted: 2015-01-26
• Study First Posted: 2015-01-30
• Last Update Posted: 2015-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• Multiple cutaneous or subcutaneous metastases of melanoma

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Exclusion Criteria

• Visceral metastases on admission.
• No current chemotherapy or immunotherapy.
• Note study performed between 1978 and 2002 before current therapies were available.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous cytokiines	Autologous cytokines	Autologous cytokines obtained from patients' blood mononuclear cells injected in volumes of 0.1 ml

Primary Outcome Measures

Name	Time	Method
Immune responses as evidenced by lymphocytic infiltrates in never-injected nodules.	Cutaneous nodules were biopsied by a surgeon afer 8 to 20 weeks of injections.	The biopsies were examined by a licensed pathologist for the presence of dense lymphocytic infiltrates.

Secondary Outcome Measures

Name	Time	Method
Complete regression of a metastasis	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.	70 % of patients had at least one nodule regress. 40 % had all metastases completely regress for 5 to 20 years (median 60 months).