Clinical trial NCT00398073: Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Intraocular Melanoma
Melanoma (Skin)
Keywords: 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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-11-10
Enrollment: 35
Sex: ALL
Minimum age (years): 1
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Number of Patients Evulated for Toxicity and Safety
timeFrame: 2 years
measure: Number of Participants With a T-cell Response
timeFrame: 2 years
Secondary outcomes:
measure: Number of Participants With Response
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jedd D. Wolchok, MD
role: PRINCIPAL_INVESTIGATOR
References: