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Inducing Systemic Immunity and Regressions in Metastatic Melanoma

NCT ID: NCT02350972

Last Updated: 2015-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

1978-07-31

Study Completion Date

2002-05-31

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.

Conditions

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Metastatic Malignant Melanoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Autologous cytokiines

Autologous cytokines obtained from patients' blood mononuclear cells injected in volumes of 0.1 ml

Group Type EXPERIMENTAL

Autologous cytokines

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

Other Intervention Names

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cytokine/chemokine

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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Fred T. Valentine

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fred T. Valentine, M.D.

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Other Identifiers

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S-1300774

Identifier Type: -

Identifier Source: org_study_id