Inducing Systemic Immunity and Regressions in Metastatic Melanoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Inducing Systemic Immunity and Regressions in Metastatic Melanoma

Conditions
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Metastatic Malignant Melanoma

Intervention / Treatment
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* Biological: Autologous cytokines


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous cytokiines<br>Autologous cytokines obtained from patients' blood mononuclear cells injected in volumes of 0.1 ml | Biological: Autologous cytokines<br>* 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.<br>* Other names: cytokine/chemokine;|

What is the study measuring?
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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. |