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 Human and Mouse gp100 DNA: A Phase I Trial to Assess Safety and Immune Response
NCT00104845CI-TRIAL-00009695completedPhase 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 DNA may make the body build an effective immune response to kill tumor cells. PURPOSE: This randomized phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with stage IIB, stage IIC, 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 |
|---|---|---|---|
| human gp100 plasmid DNA vaccine | Biological | — | UNRESOLVED |
| mouse gp100 plasmid DNA vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- human gp100 DNA vaccine
- description
- Patients receive human gp100 DNA vaccine intramuscularly (IM) once in weeks 1, 4, and 7. Patients then receive mouse gp100 DNA vaccine IM once in weeks 10, 13, and 16.
- interventionNames
- Biological: human gp100 plasmid DNA vaccine
- Biological: mouse gp100 plasmid DNA vaccine
- type
- EXPERIMENTAL
- label
- mouse gp100 DNA vaccine
- description
- Patients receive mouse gp100 DNA vaccine IM once in weeks 1, 4, and 7. Patients then receive human gp100 DNA vaccine IM once in weeks 10, 13, and 16
- interventionNames
- Biological: human gp100 plasmid DNA vaccine
- Biological: mouse gp100 plasmid DNA vaccine
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed malignant melanoma
* Stage IIB, IIC, III, or IV disease
* Patients with stage III or IV disease who are free of disease after surgical resection\* are eligible
* Patients free of disease after surgical resection\* must have refused high-dose interferon alfa OR experienced recurrent disease during prior treatment with interferon alfa NOTE: \*Patients who underwent surgical resection must have had the surgery within the past year
* HLA-A0201 positive
* No detectable brain metastases
PATIENT CHARACTERISTICS:
Age
* Any age
Performance status
* Karnofsky 80-100%
Life expectancy
* Not specified
Hematopoietic
* WBC ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 10 g/dL
* No active bleeding
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Albumin ≥ 3.5 g/dL
* AST and ALT ≤ 2.5 times ULN
* Lactate dehydrogenase ≤ 2 times ULN
* No clinical history of hepatitis B or C
Renal
* Creatinine ≤ 2.0 mg/dL
Immunologic
* No clinical history of HIV
* No clinical history of HTLV-1
* No active infection requiring antibiotics within the past 72 hours
* No history of collagen vascular, rheumatologic, or other autoimmune disorder
* No grade 1 fever within the past 72 hours
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Weight ≥ 25 kg
* No serious underlying medical condition that would preclude study participation
* No preexisting uveal or choroidal eye disease
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
* More than 4 weeks since prior immunotherapy
* No prior immunization with any class of vaccine containing gp100, including whole cell, shed antigen, or cell lysate vaccines
Chemotherapy
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
Endocrine therapy
* No concurrent corticosteroids that would preclude study participation
Radiotherapy
* More than 4 weeks since prior radiotherapy
* No concurrent radiotherapy
Surgery
* See Disease Characteristics
Other
* Recovered from all prior therapy
* No other concurrent medication that would preclude study participation
* No other concurrent investigational agents
* No other concurrent systemic therapyReferences
Publications (0)
Data not yet available
No reference posted for this study.