Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma
Injection of AJCC Stage IIB, IIC, III and IV Melanoma Patients With Mouse gp100 DNA: A Pilot Study to Compare Intramuscular Jet Injection With Particle Mediated Delivery
- 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 DNA may help the body build an effective immune response to kill tumor cells. Giving the vaccine in different ways may make a stronger immune response and kill more tumor cells. PURPOSE: This randomized clinical trial is studying two different ways of giving vaccine therapy to compare how well they work in treating patients with stage IIB, stage IIC, stage III, or stage IV melanoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intraocular Melanoma | Uveal Melanoma | ALIAS | 0.90 |
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intramuscularly (IM injection) | Other | — | UNRESOLVED |
| mouse gp100 plasmid DNA vaccine | Biological | — | UNRESOLVED |
| The Dermal PowderMed® devices | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- mouse gp100 DNA via PMED
- description
- patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.
- interventionNames
- Biological: mouse gp100 plasmid DNA vaccine
- Device: The Dermal PowderMed® devices
- type
- EXPERIMENTAL
- label
- mouse gp100 DNA injections intramuscularly
- description
- patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.
- interventionNames
- Biological: mouse gp100 plasmid DNA vaccine
- Other: intramuscularly (IM injection)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed malignant melanoma
* Stage IIB, IIC, III, or IV disease
* Patients free of disease after surgical resection must meet 1 of the following criteria:
* Refused high-dose interferon alfa
* Recurrence while on interferon alfa
* Patients with stage IIB, IIC, or III disease must have already undergone initial standard therapy (i.e., surgery) for the disease
* Choroidal (uveal) melanoma allowed provided 1 of the following criteria is met:
* Basal diameter \> 16 mm
* Basal height \> 8 mm
* Involvement of the ciliary body with tumor
* HLA-A\*0201 positive
* Negative serum antidouble-stranded DNA antibody screen
* No known brain metastases
PATIENT CHARACTERISTICS:
* Karnofsky performance status 80-100%
* Platelet count ≥ 100,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* WBC ≥ 3,000/mm\^3
* Lactic dehydrogenase ≤ 2 times upper limit of normal (ULN)
* Creatinine ≤ 2.0 mg/dL
* Bilirubin ≤ 2.5 times ULN
* Albumin ≥ 3.5 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Weight ≥ 25 kg
* No preexisting choroidal eye disease
* No serious underlying medical conditions that could be exacerbated by study participation (i.e., active infections requiring antimicrobial drugs or active bleeding)
* No allergy to gold (i.e., gold jewelry)
* No evidence of any condition at the proposed site(s) of vaccine administration that might interfere with the interpretation of local skin reactions, including any of the following:
* Damaged skin
* Moles
* Scars
* Tattoos
* Marks
* No prior medical condition or use of medication (e.g., corticosteroids) that might make it difficult for the patient to complete the full course of treatment or to respond immunologically to vaccines
* No history or evidence (within the past 5 years) of a physician-diagnosed chronic or recurrent inflammatory skin disease at the proposed site of vaccine administration, including any of the following:
* Psoriasis
* Eczema
* Atopic dermatitis
* Hypersensitivity
* No history of keloid formation
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy, immunotherapy, or radiotherapy (6 weeks for nitrosoureas) and recovered
* No prior immunization with any class of vaccine containing gp100 peptide
* No other concurrent investigational agents
* No other concurrent systemic therapy or radiotherapyReferences
Publications (0)
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