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
Metastatic Intraocular Melanoma
Recurrent Intraocular Melanoma
Stage III Melanoma
Stage IV Melanoma
Other: pharmacological study
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study Evaluating the Efficacy of VEGF Trap in Patients With Recurrent Inoperable Stage III or Stage IV Melanoma|
- Objective Response Rate (CR + PR) [ Time Frame: Start of treatment to disease progression/recurrence, up to 5 years ] [ Designated as safety issue: No ]Using the RECIST v1.0 criteria for target lesions assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response = CR + PR.",
- 4 Month PFS Rate in Comparison With Historical Data [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
The targeted 4-months PFSR was based on three recently reported (at the time of study design) phase III randomized clinical trials with a median of 2.3 months PFS as a conservative external standard. If this regimen's improved median PFS from 2.3 to 4 months, corresponding to an improvement in the 4-month PFSR from 30% to 50% using a constant hazard model, we concluded that it would warrant further study. The study design yields a 85% power to detect a true 4-month PFS rate of at least 50%.
- Overall Survival [ Time Frame: From the initial date of treatment to the recorded date of death, assessed up to 5 years ] [ Designated as safety issue: No ]Will be estimated by the Kaplan-Meier method.
- Toxicities Assessed Using NCI CTCAE v3.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
- Impact of the VEGF Trap Therapy on Laboratory Correlates [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2007|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
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.
Other Names:Other: pharmacological study
Other Name: pharmacological studies
I. Determine the antitumor response rate (complete and partial response) in patients with recurrent inoperable stage III or IV melanoma treated with VEGF Trap.
II. Compare the progression-free survival of patients treated with this regimen vs historical controls.
I. Determine the overall survival of patients treated with this regimen. II. Determine the toxicity and tolerability of this regimen in these patients. III. Determine the impact of this regimen on laboratory correlates including anti-VEGF Trap antibody testing and pharmacokinetics in these patients.
OUTLINE: This is a multicenter study.
Patients receive VEGF Trap IV 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.
Blood samples are collected at baseline, prior to course 2, and 60 days after completion of study treatment for pharmacokinetic and pharmacodynamic studies. Samples are analyzed by enzyme-linked immunosorbent assay.
After completion of study treatment, patients are followed periodically for 5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00450255
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|Principal Investigator:||Ahmad Tarhini||University of Pittsburgh|