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Inducing Systemic Immunity and Regressions in Metastatic Melanoma

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NYU Langone Health

Status and phase

Completed
Phase 1

Conditions

Metastatic Malignant Melanoma

Treatments

Biological: Autologous cytokines

Study type

Interventional

Funder types

Other

Identifiers

NCT02350972
S-1300774

Details and patient eligibility

About

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.

Full 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.

Enrollment

88 patients

Sex

All

Ages

21 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

88 participants in 1 patient group

Autologous cytokiines
Experimental group
Description:
Autologous cytokines obtained from patients' blood mononuclear cells injected in volumes of 0.1 ml
Treatment:
Biological: Autologous cytokines

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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