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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


N/A
1 Year
N/A
Not Enrolling
Both
Intraocular Melanoma, Melanoma (Skin)

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of particle-mediated epidermal delivery (PMED) of mouse gp100 plasmid DNA vaccine

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Jedd D. Wolchok, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

06-113

NCT ID:

NCT00398073

Start Date:

October 2006

Completion Date:

March 2011

Related Keywords:

  • Intraocular Melanoma
  • Melanoma (Skin)
  • 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
  • Melanoma
  • Uveal Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021