Clinical trial NCT00107718: Anti-Tumor Activity Of SB-485232 In Patients With Previously Untreated Metastatic Melanoma
Official title: A Phase II Study of IL-18 in Melanoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma
Keywords: IL-18
treatment naive
Phase 2
melanoma
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-04-08
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase II study is designed to evaluate the anti-tumor activity of three dose groups of SB-485232 (0.01, 0.1, and 1.0 mg/kg/day) administered intravenously as a single agent in subjects with previously untreated metastatic melanoma.


Eligibility criteria: Inclusion criteria:

* Patients must have melanoma that has spread beyond the original location and has not yet been treated.
* Tissue from the spreading melanoma should have been tested to confirm it is melanoma.

Exclusion criteria:

* Patients having hepatitis or HIV infection.
* Taking corticosteroids.
* Patients with the primary site being occular melanoma or patients with melanoma of the brain.

Primary outcomes:
measure: Overall response rate of tumor
timeFrame: Up to 12 months
Secondary outcomes:
measure: Number of participants with progression free survival
timeFrame: Up to 12 months
measure: Response duration of SB-485232 for tumor treatment
timeFrame: Up to 12 months
measure: Time to response
timeFrame: Up to 12 months
measure: Number of participants with adverse events (AEs), serious adverse events (SAEs), and death.
timeFrame: Up to 12 months
measure: Change from Baseline In vital signs [systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and body temperature(BT)]
timeFrame: Baseline (Day 1) to Day 15 and Day 28 of each cycle
measure: Number of participants with toxicity grade shift of clinical laboratory parameters over period.
timeFrame: Baselie (Cycle1,Day 1), Day 2, Day 15 and Follow up (28 days after last dose of Cycle 13) of each cycle
measure: Number of participants with immune response to SB485232 over period.
timeFrame: Day 15 of each cycle
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: San Francisco
country: United States
facility: GSK Investigational Site
state: California
city: Santa Monica
country: United States
facility: GSK Investigational Site
state: California
city: New Haven
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: Lutherville-Timonium
country: United States
facility: GSK Investigational Site
state: Maryland
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Toledo
country: United States
facility: GSK Investigational Site
state: Ohio
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Waratah
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Westmead
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Douglas
country: Australia
facility: GSK Investigational Site
state: Queensland
city: South Brisbane
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Woolloongabba
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Hobart
country: Australia
facility: GSK Investigational Site
state: Tasmania
city: East Melbourne
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Nedlands
country: Australia
facility: GSK Investigational Site
state: Western Australia
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: