Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Intraocular Melanoma Melanoma (Skin) |
Biological: mouse gp100 plasmid DNA vaccine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
- Safety of particle-mediated epidermal delivery (PMED) of mouse gp100 plasmid DNA vaccine [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Comparison of PMED-based DNA immunization with intramuscular jet immunization, based on T-cell response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Antitumor response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 35 |
| Study Start Date: | October 2006 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: mouse gp100 DNA via PMED
15 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.
|
Biological: mouse gp100 plasmid DNA vaccine |
|
Experimental: mouse gp100 DNA injections intramuscularly
15 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.
|
Biological: mouse gp100 plasmid DNA vaccine |
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, 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.
OUTLINE: This is a randomized, pilot study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive mouse gp100 plasmid DNA vaccine by particle-mediated epidermal delivery on days 1, 3, 5, 8, 22, 24, 26, 29, 43, 45, 47, 50, 64, 66, 68, and 71.
- Arm II: Patients receive mouse gp100 plasmid DNA vaccine by intramuscular jet injection on days 1, 3, 5, 8, 22, 24, 26, 29, 43, 45, 47, 50, 64, 66, 68, and 71.
After completion of study treatment, patients are followed periodically for 1 year.
Eligibility| Ages Eligible for Study: | 1 Year and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Principal Investigator: | Jedd D. Wolchok, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00398073 History of Changes |
| Other Study ID Numbers: | 06-113, MSKCC-06113 |
| Study First Received: | November 9, 2006 |
| Last Updated: | March 12, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
stage II melanoma stage III melanoma stage IV melanoma recurrent melanoma |
ciliary body and choroid melanoma, medium/large size ciliary body and choroid melanoma, small size recurrent intraocular melanoma metastatic intraocular melanoma |
Additional relevant MeSH terms:
|
Melanoma Uveal Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Nerve Tissue Nevi and Melanomas Eye Neoplasms Neoplasms by Site Eye Diseases Uveal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013