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| ID | Type | Description | Link |
|---|---|---|---|
| MSKCC-06113 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, pilot study. Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed periodically for 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mouse gp100 DNA via PMED | Experimental | 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. |
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| mouse gp100 DNA injections intramuscularly | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mouse gp100 plasmid DNA vaccine | Biological |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Evulated for Toxicity and Safety | All toxicity will be graded according to the National Cancer Institute (NCI) Common Toxicity Criteria v3.0. | 2 years |
| Number of Participants With a T-cell Response | 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Response | In patients with measurable disease, the RECIST criteria for anti-tumor effect will be used. Lesions will be defined as measurable if they can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm by spiral CT scan.Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. |
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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:
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:
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:
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:
No history of keloid formation
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Jedd D. Wolchok, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1_Particle-medicated Epidermal Delivery Group (Gene Gun) | 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. mouse gp100 plasmid DNA vaccine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| The Dermal PowderMed® devices |
| Device |
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| intramuscularly (IM injection) | Other |
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| 2 years |
| FG001 | 2_IM Injection (Bioinjector) | 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. mouse gp100 plasmid DNA vaccine |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 1_Particle-medicated Epidermal Delivery Group (Gene Gun) | 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. mouse gp100 plasmid DNA vaccine |
| BG001 | 2_IM Injection (Bioinjector) | 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. mouse gp100 plasmid DNA vaccine |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Evulated for Toxicity and Safety | All toxicity will be graded according to the National Cancer Institute (NCI) Common Toxicity Criteria v3.0. | Posted | Number | participants | 2 years |
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| Primary | Number of Participants With a T-cell Response | 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. | Posted | Number | participants | 2 years |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Response | In patients with measurable disease, the RECIST criteria for anti-tumor effect will be used. Lesions will be defined as measurable if they can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm by spiral CT scan.Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. | Posted | Number | participants | 2 years |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1_Particle-medicated Epidermal Delivery Group (Gene Gun) | 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. mouse gp100 plasmid DNA vaccine | 3 | 17 | 5 | 17 | ||
| EG001 | 2_IM Injection (Bioinjector) | 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. mouse gp100 plasmid DNA vaccine | 1 | 17 | 5 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergy/Immunology, other | Immune system disorders | Systematic Assessment |
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| Allergy/Immunology, other | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Edema: limb | Blood and lymphatic system disorders | Systematic Assessment |
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| Pain - Chest/thorax NOS | General disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AST, SGOT | Metabolism and nutrition disorders | Systematic Assessment |
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| Bilirubin (hyperbilirubinemia) | Hepatobiliary disorders | Systematic Assessment |
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| Glucose, high (hyperglycemia) | Metabolism and nutrition disorders | Systematic Assessment |
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| Potassium, high (hyperkalemia) | Metabolism and nutrition disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jedd Wolchok, MD, Chief Attending | Memorial Sloan Kettering Cancer Center | +1646-888-2315 | wolchokj@MSKCC.ORG |
| ID | Term |
|---|---|
| D000098943 | Uveal Melanoma |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D007273 | Injections, Intramuscular |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| >=65 years |
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| Male |
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| Counts |
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| Participants |
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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.
mouse gp100 plasmid DNA vaccine
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