High-Dose Aldesleukin and Ipilimumab in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed By Surgery

Part of paid clinical trials in Maywood, Illinois.

Sponsor
CINJRegulatory
Study ID
NCT02203604
Phase
PHASE2
Status
Terminated

Conditions

  • Recurrent Melanoma
  • Stage IIIA Melanoma
  • Stage IIIB Melanoma
  • Stage IIIC Melanoma
  • Stage IV Melanoma

Eligibility Criteria

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

Interventions

  • aldesleukin — BIOLOGICAL
    Given IV
  • ipilimumab — BIOLOGICAL
    Given IV
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

This phase II trial studies how well high-dose aldesleukin and ipilimumab works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Biological therapies, such as aldesleukin, may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Monoclonal antibodies, such as ipilimumab, interfere with the ability of tumor cells to grow and spread. Giving high-dose aldesleukin together with ipilimumab may work better in treating patients with melanoma.

Key Dates

Start date
Nov 26, 2014
Status verified
Jul 2023
Primary completion
Jan 27, 2020
Completion
Jan 27, 2020

Study Design

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

Arms

  • Experimental: Treatment (aldesleukin, ipilimumab)
    INDUCTION: Patients receive ipilimumab IV over 90 minutes on days 1, 22, 43, and 64 and high-dose aldesleukin IV on days 22-26 and 43-47. MAINTENANCE: Beginning on weeks 24, patients without disease progression or unacceptable toxicity receive ipilimumab IV over 90 minutes once every 12 weeks for up to 24 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Objective Response Rate as Determined by mWHO Criteria [ Time Frame: Up to 24 weeks ]

Locations (6)

FacilityCityStateZIPSite coordinators
Loyola University Medical CenterMaywoodIllinois60153-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Cleveland ClinicClevelandOhio44195-
Providence Portland Medical CenterPortlandOregon97213-
Vanderbilt University Medical CenterNashvilleTennessee37240-

Find similar trials in Maywood, IL

By research site
Loyola University Medical Center· Maywood, ILBeth Israel Deaconess Medical Center· Boston, MARutgers Cancer Institute of New Jersey· New Brunswick, NJCleveland Clinic· Cleveland, OHProvidence Portland Medical Center· Portland, ORVanderbilt University Medical Center· Nashville, TN

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