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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Number of Patients Evulated for Toxicity and Safety
研究概览
简要总结
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.
详细描述
OBJECTIVES:
Primary
- Evaluate the safety and feasibility of particle-mediated epidermal delivery (PMED) immunization comprising mouse gp100 plasmid DNA vaccine in patients with stage IIB, IIC, III, or IV melanoma.
- Compare the immunologic response induced with PMED vs intramuscular jet injection methods of vaccination in these patients.
Secondary
- Observe patients with measurable tumor for evidence of any antitumor response generated after vaccination.
- Assess for disease relapse in patients treated with this vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
- •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 radiotherapy
排除标准
- 未提供
研究组 & 干预措施
mouse gp100 DNA via PMED
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.
干预措施: mouse gp100 plasmid DNA vaccine (Biological)
mouse gp100 DNA via PMED
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.
干预措施: The Dermal PowderMed® devices (Device)
mouse gp100 DNA injections intramuscularly
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.
干预措施: mouse gp100 plasmid DNA vaccine (Biological)
mouse gp100 DNA injections intramuscularly
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.
干预措施: intramuscularly (IM injection) (Other)
结局指标
主要结局
Number of Patients Evulated for Toxicity and Safety
时间窗: 2 years
All toxicity will be graded according to the National Cancer Institute (NCI) Common Toxicity Criteria v3.0.
Number of Participants With a T-cell Response
时间窗: 2 years
T-cell response: Peripheral blood lymphocytes will be tested for reactivity against gp100 using an IFN-y ELISPOT, intracellular cytokine staining or MHC tetramer assay. If T-cell reactivity is induced, additional samples may be drawn to determine the duration of this reactivity. Follow-up blood samples require only 20-30 ml. MHC tetramer assays and intracellular flow cytometry studies may also be performed.
次要结局
- Number of Participants With Response(2 years)