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CompletedNCT00104845Updated Mar 12, 2013

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

A Phase 1 interventional study of human gp100 plasmid DNA vaccine and mouse gp100 plasmid DNA vaccine in Melanoma (Skin), sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2013-03-12.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
19
Allocation
Randomized
Sex
All
01

Study summary

RATIONALE: Vaccines made from DNA may make the body build an effective immune response to kill tumor cells.

PURPOSE: This randomized phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with stage IIB, stage IIC, stage III, or stage IV melanoma.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the safety and feasibility of vaccination with human and mouse gp100 DNA in patients with stage IIB, IIC, III, or IV melanoma.
  • Determine the maximum tolerated dose of this regimen in these patients.
  • Compare the antibody and T-cell response in patients treated with two different vaccination schedules.

Secondary

  • Assess antitumor response in patients treated with this regimen.

OUTLINE: This is a randomized, crossover, dose-escalation study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive human gp100 DNA vaccine intramuscularly (IM) once in weeks 1, 4, and 7. Patients then receive mouse gp100 DNA vaccine IM once in weeks 10, 13, and 16.
  • Arm II: Patients receive mouse gp100 DNA vaccine IM once in weeks 1, 4, and 7. Patients then receive human gp100 DNA vaccine IM once in weeks 10, 13, and 16.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 6-9 patients (at least 3 per treatment arm) receive escalating doses of human and mouse gp100 DNA vaccines until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 9 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed at 3 weeks and then annually for 15 years.

PROJECTED ACCRUAL: Approximately 18-27 patients will be accrued for this study within 6-9 months.

02

Conditions studied

  • Melanoma (Skin)

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Keywords

  • stage II melanoma
  • stage III melanoma
  • stage IV melanoma
  • recurrent melanoma
03

In context

Melanoma

3,005 studies on the registry are indexed under Melanoma; 519 are open to participants now.

This study's enrollment of 19 is below the median of 38 across 2,350 interventional studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 128 completed or terminated interventional studies of FDA-regulated products, 66 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant melanoma

    • Stage IIB, IIC, III, or IV disease

      • Patients with stage III or IV disease who are free of disease after surgical resection* are eligible
  • Patients free of disease after surgical resection* must have refused high-dose interferon alfa OR experienced recurrent disease during prior treatment with interferon alfa NOTE: *Patients who underwent surgical resection must have had the surgery within the past year
  • HLA-A0201 positive
  • No detectable brain metastases

PATIENT CHARACTERISTICS:

Age

  • Any age

Performance status

  • Karnofsky 80-100%

Life expectancy

  • Not specified

Hematopoietic

  • WBC ≥ 3,000/mm\^3
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 10 g/dL
  • No active bleeding

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Albumin ≥ 3.5 g/dL
  • AST and ALT ≤ 2.5 times ULN
  • Lactate dehydrogenase ≤ 2 times ULN
  • No clinical history of hepatitis B or C

Renal

  • Creatinine ≤ 2.0 mg/dL

Immunologic

  • No clinical history of HIV
  • No clinical history of HTLV-1
  • No active infection requiring antibiotics within the past 72 hours
  • No history of collagen vascular, rheumatologic, or other autoimmune disorder
  • No grade 1 fever within the past 72 hours

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Weight ≥ 25 kg
  • No serious underlying medical condition that would preclude study participation
  • No preexisting uveal or choroidal eye disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • More than 4 weeks since prior immunotherapy
  • No prior immunization with any class of vaccine containing gp100, including whole cell, shed antigen, or cell lysate vaccines

Chemotherapy

  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

Endocrine therapy

  • No concurrent corticosteroids that would preclude study participation

Radiotherapy

  • More than 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics

Other

  • Recovered from all prior therapy
  • No other concurrent medication that would preclude study participation
  • No other concurrent investigational agents
  • No other concurrent systemic therapy
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    human gp100 DNA vaccine

    Patients receive human gp100 DNA vaccine intramuscularly (IM) once in weeks 1, 4, and 7. Patients then receive mouse gp100 DNA vaccine IM once in weeks 10, 13, and 16.

    Biological: human gp100 plasmid DNA vaccine · Biological: mouse gp100 plasmid DNA vaccine

  • Experimental
    mouse gp100 DNA vaccine

    Patients receive mouse gp100 DNA vaccine IM once in weeks 1, 4, and 7. Patients then receive human gp100 DNA vaccine IM once in weeks 10, 13, and 16

    Biological: human gp100 plasmid DNA vaccine · Biological: mouse gp100 plasmid DNA vaccine

Interventions

  • Biologicalhuman gp100 plasmid DNA vaccine
  • Biologicalmouse gp100 plasmid DNA vaccine
06

What researchers measure

Primary outcomes

  1. safety and feasibility

    Time frame: 2 years

Secondary outcomes

  1. maximum tolerated dose

    Time frame: 2 years

  2. antibody and T-cell response

    Time frame: 2 years

07

Study locations

1 site
  • Memorial Sloan-Kettering Cancer Center
    New York, New York 10021, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00104845
Lead sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Mar 4, 2005
Start date
Sep 2004
Primary completion
Sep 2011
Completion
Sep 2011
Last update
Mar 12, 2013

Study contacts

Jedd D. Wolchok, MD
study chair · Memorial Sloan Kettering Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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