Inducing Systemic Immunity and Regressions in Metastatic Melanoma

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT02350972
• Collaborator: (none)
• Enrollment: 88
• Arm: 1
• Duration (Months): 286

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Malignant Melanoma	Biological: Autologous cytokines	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 88 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Inducing Systemic Immunity and Regressions in Metastatic Melanoma
• Study Start Date: Jul 1, 1978
• Actual Primary Completion Date: May 1, 2002
• Actual Study Completion Date: May 1, 2002

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

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.]

   70 % of patients had at least one nodule regress. 40 % had all metastases completely regress for 5 to 20 years (median 60 months).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• NYU Langone Health

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fred T. Valentine, Professor of Medicine, NYU Langone Health
• ClinicalTrials.gov Identifier: NCT02350972
• Other Study ID Numbers: S-1300774
• First Posted: Jan 30, 2015
• Last Update Posted: Jan 30, 2015
• Last Verified: Jan 1, 2015

• Additional relevant MeSH terms: Melanoma

Study Results

No Results Posted as of Jan 30, 2015