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

NCT ID: NCT00398073

Last Updated: 2017-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2011-03-31

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.

Conditions

Intraocular Melanoma; Melanoma (Skin)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

mouse gp100 plasmid DNA vaccine

Intervention Type: BIOLOGICAL

The Dermal PowderMed® devices

Intervention Type: DEVICE

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.

Group Type: EXPERIMENTAL

mouse gp100 plasmid DNA vaccine

Intervention Type: BIOLOGICAL

intramuscularly (IM injection)

Intervention Type: OTHER

Interventions

mouse gp100 plasmid DNA vaccine

Intervention Type: BIOLOGICAL

The Dermal PowderMed® devices

Intervention Type: DEVICE

intramuscularly (IM injection)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jedd D. Wolchok, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

MSKCC-06113

Identifier Type: -

Identifier Source: secondary_id

06-113

Identifier Type: -

Identifier Source: org_study_id