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Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00398073
Recruitment Status : Completed
First Posted : November 10, 2006
Results First Posted : March 16, 2017
Last Update Posted : March 16, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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 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 or disease Intervention/treatment Phase
Intraocular Melanoma Melanoma (Skin) Biological: mouse gp100 plasmid DNA vaccine Device: The Dermal PowderMed® devices Other: intramuscularly (IM injection) Phase 1

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2006
Primary Completion Date : March 2011
Study Completion Date : March 2011


Arms and Interventions

Arm Intervention/treatment
Experimental: 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.
Biological: mouse gp100 plasmid DNA vaccine Device: The Dermal PowderMed® devices
Experimental: 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.
Biological: mouse gp100 plasmid DNA vaccine Other: intramuscularly (IM injection)


Outcome Measures

Primary Outcome Measures :
  1. Number of Patients Evulated for Toxicity and Safety [ Time Frame: 2 years ]
    All toxicity will be graded according to the National Cancer Institute (NCI) Common Toxicity Criteria v3.0.

  2. Number of Participants With a T-cell Response [ Time Frame: 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.


Secondary Outcome Measures :
  1. Number of Participants With Response [ Time Frame: 2 years ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 120 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00398073


Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jedd D. Wolchok, MD Memorial Sloan Kettering Cancer Center
More Information

Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00398073     History of Changes
Other Study ID Numbers: 06-113
MSKCC-06113
First Posted: November 10, 2006    Key Record Dates
Results First Posted: March 16, 2017
Last Update Posted: March 16, 2017
Last Verified: January 2017

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
Vaccines
Immunologic Factors
Physiological Effects of Drugs