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

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ClinicalTrials.gov Identifier: NCT00104845
Recruitment Status : Completed
First Posted : March 4, 2005
Last Update Posted : March 12, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief 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.


Condition or disease Intervention/treatment Phase
Melanoma (Skin) Biological: human gp100 plasmid DNA vaccine Biological: mouse gp100 plasmid DNA vaccine Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Injection of AJCC Stage IIB, IIC, III, and IV Melanoma Patients With Human and Mouse gp100 DNA: A Phase I Trial to Assess Safety and Immune Response
Study Start Date : September 2004
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. safety and feasibility [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. maximum tolerated dose [ Time Frame: 2 years ]
  2. antibody and T-cell response [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00104845


Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Jedd D. Wolchok, MD Memorial Sloan Kettering Cancer Center

Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00104845     History of Changes
Other Study ID Numbers: 03-007
P30CA008748 ( U.S. NIH Grant/Contract )
MSKCC-IRB-03007
First Posted: March 4, 2005    Key Record Dates
Last Update Posted: March 12, 2013
Last Verified: March 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
stage II melanoma
stage III melanoma
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Vaccines
Immunologic Factors
Physiological Effects of Drugs