Immunogenicity and Biomarker Analysis of Neoadjuvant Ipilimumab for Melanoma

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Diwakar Davar
Study ID
NCT00972933
Phase
EARLY_PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ipilimumab — DRUG
    Excisional Biopsy - baseline Induction ipilimumab 10 mg/kg IV day 0, 21 - baseline and week 3 Complete lymph node dissection - week ≥ 6 Maintenance Ipilimumab 10 mg/kg IV - Days 63 (+28 days) and, 84 (+28 days) - (3 weeks apart, starting 2-4 weeks following definitive lymphadenectomy)

Study Details

Ipilimumab is a manufactured monoclonal antibody, much like the antibodies usually made by the human body to fight off infection; however it is not known why the human body does not "fight off" a cancerous tumor. The idea behind developing this experimental drug is to stimulate the immune system to make antibodies to kill cancer cells. This research study is considered "experimental" because it has not received approval from the Food and Drug Administration (FDA) for the treatment of this type of cancer. This monoclonal antibody has been specifically made to block Cytotoxic T Lymphocyte Antigen 4 (CTLA4), which is a protein found on cells of the immune system. CTLA4 seems to slow down the immune response, so blocking it with an anti-CTLA4 antibody may make the immune response more active. The purpose of this study is to see if Ipilimumab affects the response of the patient's immune system toward their cancer.

Key Dates

Start date
Dec 31, 2009
Status verified
Dec 2017
Primary completion
Jul 17, 2013
Completion
Sep 26, 2017

Study Design

Enrollment
59 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ipilimumab
    Induction ipilimumab 10 mg/kg IV day 0, 21 (baseline, week 3) Maintenance Ipilimumab 10 mg/kg IV days 63 (+28 days) and, 84 (+28 days) - (3 weeks apart, starting 2-4 weeks following definitive lymphadenectomy)

Primary Outcome Measure

To study the effects of ipilimumab upon the host immune response in nodal metastatic melanoma and in the peripheral blood comparing pre-treatment with post-treatment (baseline, 6 weeks) immunologic features. [ Time Frame: 2.5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pittsburgh Medical Center/University of Pittsburgh Cancer InstitutePittsburghPennsylvania15232-

Find similar trials in Pittsburgh, PA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
University of Pittsburgh Medical Center/University of Pittsburgh Cancer Institute· Pittsburgh, PA

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