Phase 2
N=41
VEGF Trap in Treating Patients With Recurrent Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
Ciliary Body and Choroid Melanoma, Medium/Large Size · Extraocular Extension Melanoma · Iris Melanoma · Metastatic Intraocular Melanoma · Recurrent Intraocular Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT00450255 ↗Enrolled (actual)
41
Serious AEs
31.7%
Results posted
Feb 2015
Primary outcome: Primary: Objective Response Rate (CR + PR) — 7.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ziv-aflibercept (Biological); pharmacological study (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (CR + PR) |
7.5 | — |
| PRIMARY 4 Month Progression-free Survival |
50 | — |
| SECONDARY Overall Survival |
16.3 | — |
| SECONDARY Number of Participants With Toxicities |
1; 9; 1; 1; 1; 0 | — |
| SECONDARY Impact of the VEGF Trap Therapy on Laboratory Correlates |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed stage III or IV melanoma
- Cutaneous, ocular, or mucosal melanoma allowed
- Recurrent, inoperable disease
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- No evidence of CNS disease, including primary brain tumor or brain metastases
- No brain metastases by MRI or CT scan within the past 4 weeks
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- Life expectancy > 3 months
- WBC ≥ 3,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 75,000/mm³
- Bilirubin 150/100 mm Hg or systolic BP > 180 mm Hg if diastolic BP 1.5 allowed provided the following criteria are met:
- INR in range (2-3) on a stable dose of oral anticoagulant or low molecular weight heparin
- No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
Data sourced from ClinicalTrials.gov (NCT00450255). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.