Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
En Vivo Matured Dendritic Cell Therapy in Patients With Melanoma
NCT00085488CI-TRIAL-00016752completedPhase 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)
RATIONALE: Vaccines made from a patient's dendritic cells and tumor cells may make the body build an immune response to kill tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with 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 |
|---|---|---|---|
| autologous tumor cell vaccine | Biological | — | UNRESOLVED |
| therapeutic autologous dendritic cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Ex Vivo Matured Dendritic Cell Therapy in Patients with Melanoma
- timeFrame
- 2005-2006
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed melanoma * Stage III (lymph node or in-transit metastases) or IV (systemic metastases) disease * Patients with relapsed disease OR who failed prior immunotherapy or chemotherapy are eligible (but trial not restricted to relapsed or refractory disease) * Tumor tissue available and properly stored for lysate preparation PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 75,000/mm\^3 Hepatic * AST ≤ 2 times upper limit of normal (ULN) (3 times ULN for liver metastases) * Bilirubin ≤ 2 times ULN * Hepatitis B surface antigen negative * Hepatitis C negative Renal * Creatinine ≤ 2.0 times ULN Immunologic * No active infection * No history of autoimmune disease, including any of the following: * Inflammatory bowel disease * Systemic lupus erythematosus * Scleroderma * Rheumatoid arthritis * Multiple sclerosis * No allergy to aminoglycosides or streptomycin * HIV negative Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No significant comorbid illness * No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * At least 10 days since prior immunotherapy Chemotherapy * See Disease Characteristics Endocrine therapy * At least 6 weeks since prior steroid therapy * No concurrent corticosteroids Radiotherapy * At least 10 days since prior radiotherapy * No concurrent radiotherapy Surgery * At least 10 days since prior surgery * Prior diagnostic or palliative surgery allowed provided the patient has fully recovered Other * No concurrent immunosuppressive or potentially immunosuppressive therapy
References
Publications (0)
Data not yet available
No reference posted for this study.