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 With Prior Depletion of CD25-Positive Cells Using Denileukin Difitox (ONTAK)
- 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. Biological therapies such as denileukin diftitox may be able to deliver cancer-killing substances directly to melanoma cells. Combining vaccine therapy with biological therapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining vaccine therapy with denileukin diftitox 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dendritic cell vaccine plus denileukin difitox | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Safety and tolerability as assessed by clinical and laboratory evaluation at every visit
- measure
- Overall survival as assessed by clinical staging (CT scan and positron emission tomography [PET]) every 3 months
Secondary outcomes (4)
- measure
- Depletion of regulatory T-cells as assessed by tetramer stainings at every visit
- measure
- Induction of antigen-specific immune responses as assessed by elispot and tetramer staining at every visit
- measure
- Time to progression as assessed by clinical staging (CT scan and PET) every 3 months
- measure
- Objective response rate as assessed by clinical staging (CT scan and PET) every 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed locoregional or metastatic cutaneous malignant melanoma
* Stage III or IV disease
* Stage III: pT4b, N0, M0 (satellite metastases) or any pT, N1 or pT, N1 or N2a-c, M0 (lymph node metastases or in transit intralymphatic metastases)
* Stage IV: any pT, N1-2, M1a-b
* Surgically incurable
* Incurable with standard treatment (i.e., localized chemotherapy/limb perfusion for stage III, systemic chemotherapy for stage IV)
* Unidimensionally or bidimensionally measurable disease by physical examination (e.g., cutaneous metastases) and/or non-invasive radiologic procedures NOTE: Stage III lesions may be measurable lymph nodes after incomplete resection and/or inoperable in transit metastases
* HLA-A1 and/or HLA-A2 expression by serologic HLA typing
* HLA-A2.01 subtype must be confirmed by polymerase chain reaction on genomic DNA obtained from peripheral blood mononuclear cells
* No active CNS metastases
* Previously treated CNS metastases (e.g., excision of a single metastasis) allowed if no active disease present by CT scan or MRI
PATIENT CHARACTERISTICS:
Age
* Over 18
Performance status
* Karnofsky 60-100%
Life expectancy
* At least 6 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
* No hepatitis B or C
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 lymphocytic virus-1
* No active autoimmune disease including, but not limited to:
* Lupus erythematosus
* Autoimmune thyroiditis or uveitis
* Multiple sclerosis
* Inflammatory bowel disease NOTE: Vitiligo allowed
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 4 weeks after study participation
* No organic brain syndrome or significant psychiatric abnormality that would preclude study participation and follow-up
* No contraindication to leukapheresis
* No other active malignant neoplasms
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 4 weeks since prior systemic immunotherapy
* No concurrent immunotherapy during and for 2 weeks after last vaccination
Chemotherapy
* See Disease Characteristics
* More than 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas \[e.g., fotemustine\])
* No concurrent chemotherapy during and for 2 weeks after last vaccination
Endocrine therapy
* No concurrent corticosteroids during and for 2 weeks after last vaccination
Radiotherapy
* No prior radiotherapy to the spleen
* Concurrent palliative radiotherapy allowed for selected metastases (e.g., pain or local complications such as compression)
Surgery
* See Disease Characteristics
* Recovered from prior surgery
* No prior splenectomy
* No prior organ allografts
* Concurrent surgery of selected metastases (e.g., pain or local complications such as compression) allowed
Other
* No other concurrent investigational drugs during and for 2 weeks after last vaccination
* No concurrent paramedical substance during and for 2 weeks after last vaccination
* No concurrent participation or intent to participate in another clinical trialReferences
Publications (1)
- DERIVEDBaur AS, Lutz MB, Schierer S, Beltrame L, Theiner G, Zinser E, Ostalecki C, Heidkamp G, Haendle I, Erdmann M, Wiesinger M, Leisgang W, Gross S, Pommer AJ, Kampgen E, Dudziak D, Steinkasserer A, Cavalieri D, Schuler-Thurner B, Schuler G. Denileukin diftitox (ONTAK) induces a tolerogenic phenotype in dendritic cells and stimulates survival of resting Treg. Blood. 2013 Sep 26;122(13):2185-94. doi: 10.1182/blood-2012-09-456988. Epub 2013 Aug 19. PMID 23958949