Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
Phase I Evaluation of Alpha-Type-1 DC-Based and cDC-Based Intralymphatic Vaccines in Patients With Metastatic Melanoma
NCT00390338CI-TRIAL-00029665completedPhase 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 person's dendritic cells mixed with tumor peptides and proteins may help the body build an effective immune response to kill tumor cells. Infusing the vaccine directly into the lymphatic system may cause a stronger immune response and kill more tumor cells. PURPOSE: This randomized phase I trial is studying the side effects and best dose of two dendritic cell vaccines 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 |
|---|---|---|---|
| non-polarized dendritic cells | Biological | — | UNRESOLVED |
| polarized dendritic cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- peptide-pulsed type-1-polarized dendritic cells
- description
- intralymphatic vaccination with peptide-pulsed type-1-polarized dendritic cells (aDC1)
- interventionNames
- Biological: polarized dendritic cells
- type
- EXPERIMENTAL
- label
- peptide-pulsed mature non-polarized dendritic cells (cDCs)
- description
- intralymphatic vaccination with peptide-pulsed mature non-polarized dendritic cells (cDCs)
- interventionNames
- Biological: non-polarized dendritic cells
Primary outcomes (1)
- measure
- Safety of intralymphatic autologous type-1-polarized dendritic cell vaccine and autologous mature dendritic cell vaccine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Pathologically confirmed stage III or IVA (M1a) melanoma * Recurrent and inoperable disease * Any tumor thickness and any number of lymph nodes involved * Asymptomatic cutaneous and nodal disease allowed * Asymptomatic pulmonary metastatic disease (stage IVB, M1b) allowed * No advanced symptomatic visceral disease, including any symptomatic visceral organ involvement, or disease associated with increased serum lactic dehydrogenase \> 2.5 times upper limit of normal (stage IVC, M1c) * Standard curative or palliative measures do not exist or are no longer effective * Sufficient numbers of monocytes (≥ 20 x 10\^6) must be obtained for the preparation of the vaccine * If an insufficient number of cells is obtained on first venipuncture, a second venipuncture may be performed (not exceeding 550 mL of blood within 8 weeks) * No brain metastases by contrast-enhanced CT scan or MRI * Prior brain metastases allowed provided they were successfully treated and patient has been asymptomatic for ≥ 3 months * HLA-A2 positive PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Life expectancy ≥ 6 months * Granulocyte count ≥ 1,500/mm³ * Lymphocyte count ≥ 500/mm³ * Platelet count \> 70,000/mm³ (for venipuncture/pheresis procedure) * Creatinine ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN * Gamma-glutamyl transferase ≤ 2.5 times ULN * Lactic dehydrogenase ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN * Bilirubin ≤ 1.5 times ULN * No active infection * No sensitivity to drugs that provide local anesthesia * No pain uncontrolled by oral analgesics, including opiates and opiate analogs * No active autoimmune disease * No HIV, hepatitis B, or hepatitis C positivity * Not pregnant or nursing * Fertile patients must use effective contraception * Negative pregnancy test * No other malignancy except for nonmelanoma skin cancers or carcinoma in situ of the cervix, or other malignancy for which the patient has been continuously disease-free for ≥ 2 years PRIOR CONCURRENT THERAPY: * Recovered from prior surgery * No radiotherapy, chemotherapy, or immunotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C) * No antibiotics within the past 7 days * No systemic immunosuppressive agents, including steroids, within the past 4 weeks * Concurrent maintenance steroids for adrenal insufficiency allowed * No other concurrent anticancer investigational or commercial agents or therapies
References
Publications (0)
Data not yet available
No reference posted for this study.