VEGF Trap in Treating Patients With Recurrent Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery

Part of paid clinical trials in Duarte, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00450255
Phase
PHASE2
Status
Completed

Conditions

  • Ciliary Body and Choroid Melanoma, Medium/Large Size
  • Extraocular Extension Melanoma
  • Iris Melanoma
  • Metastatic Intraocular Melanoma
  • Recurrent Intraocular Melanoma
  • Recurrent Melanoma
  • Stage III Melanoma
  • Stage IV Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • ziv-aflibercept — BIOLOGICAL
    Given IV
  • pharmacological study — OTHER
    Correlative studies

Study Details

This phase II trial is studying how well VEGF Trap works in treating patients with recurrent stage III or stage IV melanoma that cannot be removed by surgery. Combinations of biological substances in VEGF Trap may be able to carry tumor-killing substances directly to melanoma cells. It may also stop the growth of melanoma by blocking blood flow to the tumor.

Key Dates

Start date
Jun 30, 2007
Status verified
Apr 2018
Primary completion
Jan 31, 2011
Completion
Jan 31, 2011

Study Design

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

Arms

  • Experimental: Arm I
    Patients receive Aflibercept IV at 4 mg/kg over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Objective Response Rate (CR + PR) [ Time Frame: Start of treatment to disease progression/recurrence, up to 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-

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