Status:
COMPLETED
Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Intraocular Melanoma
Melanoma (Skin)
Eligibility:
All Genders
1-120 years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
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,...
Eligibility Criteria
Inclusion
- 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 radiotherapy
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00398073
Start Date
October 1 2006
End Date
March 1 2011
Last Update
March 16 2017
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021