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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 October 2012 |
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Main ID: |
NCT00273910 |
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Date of registration:
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07/01/2006 |
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Primary sponsor: |
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Public title:
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Evaluation of the Impact of Adjuvants Accompanying Peptide Immunization in High-Risk Melanoma
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Scientific title:
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Evaluation of the Impact of Adjuvants Accompanying Peptide Immunization in High Risk Melanoma |
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Date of first enrolment:
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January 2006 |
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Target sample size:
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104 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00273910 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Steven A Rosenberg, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Cancer Institute, National Institutes of Health |
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Key inclusion & exclusion criteria
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- INCLUSION CRITERIA:
HLA-A 0201 patients, age greater than or equal to 16 years, primary melanomas with lesions
that are ulcerated and greater than or equal to 2mm, or any lesions that are greater than
or equal to 4.0 mm in thickness, or greater than or equal to1 positive lymph node, or
local recurrence, or resected metastatic disease, within 6 months of surgical resection
will be considered. Patients must be clinically disease free at the time of protocol entry
as documented by radiologic studies within 6 weeks of patient entry.
Serum creatinine of 2.0 mg/dl or less
Total bilirubin 1.6 mg/dl or less, except for patients with Gilbert's Syndrome who must
have a total bilirubin less than 3.0 mg/dl.
WBC 3000/mm^3 or greater,
Platelet count 90,000 mm^3 or greater,
Serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than three
times normal,
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Patients of both genders must be willing to practice effective birth control during this
trial because the potential for teratogenic effects are unknown.
Patients may have had prior adjuvant treatment with immunotherapy, including interferon,
as long as 3 weeks have elapsed since prior systemic therapy.
EXCLUSION CRITERIA:
Patients will be excluded:
Who have ocular or mucosal melanoma.
Who are undergoing or have undergone in the past 3 weeks any systemic therapy except
surgery for their cancer, and must have recovered to a grade I from any adverse effects of
treatment prior to entry, other than those that do not have clinical implications, e.g.
vitiligo, alopecia.
Have active systemic infections, autoimmune disease or any known immunodeficiency disease.
Who require systemic steroid therapy.
Who are pregnant (because of possible side effects on the fetus) or breastfeeding because
of unknown effects on the developing child).
Who are known to be positive for hepatitis BsAG or human immunodeficiency virus (HIV)
antibody (because of possible immune effects of these conditions).
Who have any form of autoimmune disease (such as autoimmune colitis or Crohn's Disease) or
immunodeficiency as evidenced by abnormal white blood count (WBC) count 8 and/or presence
of opportunistic infections. Must have recovered immune competence after radiation
therapy. (The experimental treatment being evaluated in this protocol depends on an intact
immune system. Patients who have decreased immune competence may be less responsive to the
experimental treatment and more susceptible to its toxicities.)
Who have previously been immunized with gp100.
Who have known hypersensitivity to any of the agents used in this study.
Who have previously received chemotherapy for treatment of melanoma.
Age minimum:
7 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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High-Risk Melanoma
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Intervention(s)
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Drug: gp100:209-217 (210M)
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Drug: Imiquimod
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Drug: Montanide ISA-51
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Primary Outcome(s)
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Immunologic Response Rate
[Time Frame: 48 months]
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Secondary Outcome(s)
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Number of Participants With Adverse Events
[Time Frame: 48 months]
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Secondary ID(s)
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06-C-0069
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060069
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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