A Study of Intratumoral Injection of Interleukin-2 and Ipilimumab in Patients With Unresectable Stages III-IV Melanoma

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT01672450
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Intratumoral Ipilimumab and Interleukin-2 — DRUG
    Only 1 lesion, 0.5 -2 cm, will be treated. Interleukin-2, 3 mIU IT TIW x 2 weeks (days 1, 3 and 5), then BIW x 6 weeks (days 1 and 4). Escalating doses of Ipilimumab (0.1, 0.25, 0.5, 1, 2, mg) IT weekly x 8 weeks

Study Details

This is a single center, open phase I dose escalation study. This study will assess the highest tolerable intratumoral dose of ipilimumab (Yervoy) in combination with IL-2 (Proleukin) in patients with unresectable stages III-IV melanoma with accessible cutaneous, subcutaneous, and/or nodal lesions. The objective is to primarily assess the safety of the drug combination, and to secondarily obtain preliminary data on the clinical efficacy of the combination.

Key Dates

Start date
Sep 30, 2012
Status verified
Jul 2015
Primary completion
Aug 31, 2014
Completion
Aug 31, 2014

Study Design

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

Arms

  • Experimental: All patients
    All participants in this study will receive the same treatment.

Primary Outcome Measure

Number of Adverse Events per patient [ Time Frame: 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Huntsman Cancer InstituteSalt Lake CityUtah84112-

Find similar trials in Salt Lake City, UT

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Huntsman Cancer Institute· Salt Lake City, UT

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