CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
ziv-aflibercept +1 morebiological
Likely dose
ziv-aflibercept given IVAI-extracted
Key inclusion· 7
  • ✓Histologically confirmed stage III or IV melanoma (cutaneous, ocular, or mucosal)
  • ✓Recurrent, inoperable disease
  • ✓Measurable disease: ≥1 lesion ≥20 mm by conventional techniques OR ≥10 mm by spiral CT
  • ✓No evidence of CNS disease, including no brain metastases by imaging within 4 weeks
Key exclusion· 9
  • ✕Evidence of CNS disease, primary brain tumor, or brain metastases
  • ✕Clinically significant cardiovascular disease including stroke, MI, unstable angina, NYHA class III-IV heart failure, or thromboembolic events within 6 months
  • ✕Uncontrolled hypertension (BP >150/100 or systolic >180 if diastolic <90) within past 3 months
  • ✕Evidence of bleeding diathesis or coagulopathy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00450255
NCT00450255Phase 2Completed
CompareCT.gov

A Phase 2 Study Evaluating the Efficacy of VEGF Trap in Patients With Recurrent Inoperable Stage III or Stage IV Melanoma

National Cancer Institute (NCI)·interventional·Posted Mar 22, 2007·Updated May 24, 2018

In Brief

A Phase 2 clinical trial evaluating ziv-aflibercept and pharmacological study for Ciliary Body and Choroid Melanoma, Medium/Large Size and 7 related conditions. Completed, enrolled 41 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCiliary 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
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 22, 2007
Enrollment StartJun 1, 2007
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 19.3 years ago

Interventions

ziv-afliberceptbiological

Given IV

pharmacological studyother

Correlative studies