Clinical trial · Interventional
Inducing Systemic Immunity and Regressions in Metastatic Melanoma
NCT02350972CI-TRIAL-00016741completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Malignant Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous cytokines | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Autologous cytokiines
- description
- Autologous cytokines obtained from patients' blood mononuclear cells injected in volumes of 0.1 ml
- interventionNames
- Biological: Autologous cytokines
Primary outcomes (1)
- measure
- Immune responses as evidenced by lymphocytic infiltrates in never-injected nodules.
- timeFrame
- Cutaneous nodules were biopsied by a surgeon afer 8 to 20 weeks of injections.
- description
- The biopsies were examined by a licensed pathologist for the presence of dense lymphocytic infiltrates.
Secondary outcomes (1)
- measure
- Complete regression of a metastasis
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.