Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Stage IV Cutaneous Melanoma
Vaccination of Stage IV Cutaneous Melanoma Patients With Mature, Autologous Monocyte-Derived Dendritic Cells Transfected With RNAs Encoding for Mage-3, MelanA, and Survivin Antigens
NCT00074230CI-TRIAL-00017865completedPhase 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 dendritic cells and antigens may make the body build an immune response to kill tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy using autologous dendritic cells with antigens in treating patients who have stage IV cutaneous 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Dendritic Cells loaded with MAGE-A3, MelanA and Survivin | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Safety and tolerability at every visit
- timeFrame
- 3 months
- measure
- Overall survival as assessed by clinical staging (CT scan, positron emission tomography [PET]) every 3 months
- timeFrame
- 3 months
Secondary outcomes (4)
- measure
- Time to progression as assessed by clinical staging (CT scan, PET) every 3 months
- timeFrame
- 3 months
- measure
- Objective tumor response as assessed by clinical staging (CT scan, PET) every 3 months
- timeFrame
- 3 months
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed cutaneous\* melanoma * Stage IV * Incurable by surgical resection * Progressive disease after at least 1 standard chemotherapy or chemoimmunotherapy regimen (e.g., dacarbazine or cisplatin monotherapy) * Unidimensionally or bidimensionally measurable disease by physical examination (e.g., cutaneous metastases) and/or noninvasive radiological procedures * No active CNS metastases by CT scan or MRI * Previously treated (e.g., excision of a single metastasis) CNS metastases are allowed provided there are no signs of active CNS metastases NOTE: \*Metastatic melanoma with unidentified primary tumor allowed provided an ocular melanoma can be definitely excluded and origin from the skin is likely PATIENT CHARACTERISTICS: Age * 18 and over 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 disorder Hepatic * Bilirubin less than 2.0 mg/dL * No evidence of hepatitis B or C infection Renal * Creatinine less than 2.5 mg/dL Cardiovascular * No clinically significant heart disease Pulmonary * No respiratory disease Immunologic * HIV-1 and HIV-2 negative * HTLV-1 negative * No active systemic infection * No immunodeficiency disease * No active autoimmune disease (e.g., lupus erythematosus, autoimmune thyroiditis or uveitis, multiple sclerosis, or inflammatory bowel disease) * Vitiligo allowed Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 4 weeks after study participation * Stable medical condition * No other major serious illness * No contraindication to leukapheresis * No organic brain syndrome or significant psychiatric abnormality that would preclude study participation or follow-up * No other active malignant neoplasm PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior immunotherapy * No other concurrent immunotherapy during and for 2 weeks after study participation Chemotherapy * More than 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas \[e.g., fotemustine\]) * No concurrent chemotherapy during and for 2 weeks after study participation Endocrine therapy * No concurrent corticosteroids during and for 2 weeks after study participation Radiotherapy * More than 2 weeks since prior radiotherapy * No prior radiotherapy to the spleen * Concurrent palliative radiotherapy to selected metastases (e.g., due to pain or local complications such as compression) is allowed Surgery * Recovered from prior surgery * No prior splenectomy * No prior organ allografts * Concurrent surgical therapy to selected metastases (e.g., due to pain or local complications such as compression) is allowed * Selected accessible metastases may be removed for tumor infiltrating lymphocyte assay or other immunomonitoring investigations (e.g., expression of tumor antigens and HLA molecules) Other * No other concurrent investigational drug or paramedical substance during and for 2 weeks after study participation * No concurrent participation in another clinical trial * Concurrent palliative medication allowed (e.g., acetaminophen, indomethacin, or opiates)
References
Publications (0)
Data not yet available
No reference posted for this study.