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Intraocular MelanomaPhase 1NCT00398073

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

A Phase 1 study testing mouse gp100 plasmid DNA vaccine, The Dermal PowderMed® devices and intramuscularly (IM injection) in people with Intraocular Melanoma and Melanoma (Skin), run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year to 120 years
Conditions the study is for
Intraocular Melanoma, Melanoma (Skin)
What is being tested?
mouse gp100 plasmid DNA vaccine, The Dermal PowderMed® devices and intramuscularly (IM injection)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
Oct 2006to Mar 2011
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 120 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
mouse gp100 plasmid DNA vaccine, The Dermal PowderMed® devices, intramuscularly (IM injection)
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
Medical subject headings
Uveal Melanoma, Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mouse gp100 plasmid DNA vaccineBiological

  • The Dermal PowderMed® devicesDevice

  • intramuscularly (IM injection)Other

Study groups in NCT00398073
Study groupRoleWhat they receive
mouse gp100 DNA via PMEDExperimentalpatients 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.
Receives: Biological: mouse gp100 plasmid DNA vaccine; Device: The Dermal PowderMed® devices
mouse gp100 DNA injections intramuscularlyExperimentalpatients 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.
Receives: Biological: mouse gp100 plasmid DNA vaccine; Other: intramuscularly (IM injection)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients Evulated for Toxicity and Safety

    All toxicity will be graded according to the National Cancer Institute (NCI) Common Toxicity Criteria v3.0.

    Measured: 2 years

  2. Number of Participants With a T-cell Response

    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.

    Measured: 2 years

Secondary outcomes (1)

  1. Number of Participants With Response

    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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionMar 2011
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00398073
Sponsor's protocol ID
06-113
Other IDs
MSKCC-06113
Status last verified
Jan 2017
First submitted
9 Nov 2006
Last updated
16 Mar 2017

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing mouse gp100 plasmid DNA vaccine, The Dermal PowderMed® devices and intramuscularly (IM injection) in people with Intraocular Melanoma and Melanoma (Skin), run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients Evulated for Toxicity and Safety (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00398073.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2017.

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