Inducing Systemic Immunity and Regressions in Metastatic Melanoma

NCT02350972 | Completed Phase 1

• 1 other identifier: S-1300774
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metastatic Malignant Melanoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (1)

Autologous cytokiines

EXPERIMENTAL

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

Biological: Autologous cytokines

Interventions

Autologous cytokines 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.

Also known as: cytokine/chemokine

Autologous cytokiines

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Multiple cutaneous or subcutaneous metastases of melanoma

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead

MeSH Terms

Conditions

Melanoma

Interventions

Cytokines; Chemokines

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chemotactic Factors; Inflammation Mediators

Study Officials

• Fred T. Valentine, M.D.

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: January 14, 2015
• First Posted: January 30, 2015
• Study Start: July 1, 1978
• Primary Completion: May 1, 2002
• Study Completion: May 1, 2002
• Last Updated: January 30, 2015

Record last verified: 2015-01