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Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma
This study is ongoing, but not recruiting participants.
First Received: November 9, 2006   Last Updated: April 3, 2009   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00398073
  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
Procedure: adjuvant therapy

Study Type: Interventional
Study Design: Treatment, Randomized
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Safety of particle-mediated epidermal delivery (PMED) of mouse gp100 plasmid DNA vaccine [ Designated as safety issue: Yes ]
  • Comparison of PMED-based DNA immunization with intramuscular jet immunization, based on T-cell response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Antitumor response [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2006
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
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.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Jedd D. Wolchok, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000513257, MSKCC-06113
Study First Received: November 9, 2006
Last Updated: April 3, 2009
ClinicalTrials.gov Identifier: NCT00398073     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Eye Neoplasms
Uveal Melanoma
Eye Diseases
Adjuvants, Immunologic
Melanoma of the Choroid
Recurrence
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Intraocular Melanoma
Neuroepithelioma
Nevus

Additional relevant MeSH terms:
Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Eye Neoplasms
Eye Diseases
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on September 11, 2009