Metastatic Malignant Melanoma
Conditions
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.
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.
Interventions
BIOLOGICALAutologous 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.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Outcome results
None listed