Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
Vaccination Of HLA-A1 And/Or -A2+ Stage III or IV Melanoma Patients With Tumor Peptide - Loaded Autologous Dendritic Cells That Are Generated In The Absence Or Presence Of CD40 Ligand
NCT00053391CI-TRIAL-00017875completedPhase 1 / Phase 2ClinicalTrials.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)
RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have stage III or stage IV melanoma.
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 |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| recombinant CD40-ligand | Biological | — | UNRESOLVED |
| therapeutic autologous dendritic cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Comparison of the efficacy of vaccination with vs without ex vivo CD40-ligand in terms of tumor-specific T-cell response
- measure
- Safety
- measure
- Tolerability
Secondary outcomes (2)
- measure
- Tumor response
- measure
- Recurrence rates
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed stage III or IV cutaneous malignant melanoma * HLA-A1 and/or HLA-A2 expression by serologic HLA typing * HLA-A2.1 subtype must be confirmed by polymerase chain reaction on genomic DNA obtained from peripheral blood mononuclear cells * No active CNS metastases by CT scan or MRI PATIENT CHARACTERISTICS: Age * Over 18 Performance status * Karnofsky 60-100% Life expectancy * At least 4 months Hematopoietic * WBC greater than 2,500/mm\^3 * Neutrophil count greater than 1,000/mm\^3 * Lymphocyte count greater than 700/mm\^3 * Platelet count greater than 75,000/mm\^3 * Hemoglobin greater than 9 g/dL * No bleeding disorders Hepatic * Bilirubin less than 2.0 mg/dL * Hepatitis B surface antigen negative * Hepatitis C antibody negative Renal * Creatinine less than 2.5 mg/dL Cardiovascular * No clinically significant heart disease Pulmonary * No clinically significant respiratory disease Immunologic * No active systemic infection * No immunodeficiency disease * No evidence of HIV-1, HIV-2, or human T-cell lymphotropic virus-1 * No active autoimmune disease including (but not limited to): * Lupus erythematosus * Autoimmune thyroiditis or uveitis * Multiple sclerosis * Inflammatory bowel disease Other * Stable medical condition * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 1 month after study participation * No organic brain syndrome or psychiatric illness that would preclude study compliance * No other concurrent active malignancy * No other concurrent serious illness that would preclude study treatment * No contraindication to leukapheresis PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior immunotherapy * No other concurrent immunotherapy Chemotherapy * More than 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas) * No concurrent chemotherapy Endocrine therapy * No concurrent corticosteroids Radiotherapy * More than 4 weeks since prior radiotherapy * No prior radiotherapy to the spleen * Concurrent palliative radiotherapy allowed Surgery * Recovered from prior surgery * No prior splenectomy * No prior organ allograft * Concurrent surgery on selected metastases (e.g., because of pain or local complications such as compression) allowed Other * No other concurrent investigational drugs * No concurrent participation in another clinical trial
References
Publications (1)
- DERIVEDGross S, Erdmann M, Haendle I, Voland S, Berger T, Schultz E, Strasser E, Dankerl P, Janka R, Schliep S, Heinzerling L, Sotlar K, Coulie P, Schuler G, Schuler-Thurner B. Twelve-year survival and immune correlates in dendritic cell-vaccinated melanoma patients. JCI Insight. 2017 Apr 20;2(8):e91438. doi: 10.1172/jci.insight.91438. eCollection 2017 Apr 20. PMID 28422751