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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00450255
Recruitment Status : Completed
First Posted : March 22, 2007
Results First Posted : February 4, 2015
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
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
Interventions: Biological: ziv-aflibercept
Other: pharmacological study

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

ziv-aflibercept: Given IV

pharmacological study: Correlative studies


Participant Flow:   Overall Study
    Arm I
STARTED   41 
COMPLETED   40 
NOT COMPLETED   1 
Prior RFA ablation of liver                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

ziv-aflibercept: Given IV

pharmacological study: Correlative studies


Baseline Measures
   Arm I 
Overall Participants Analyzed 
[Units: Participants]
 41 
Age 
[Units: Years]
Median (Full Range)
 57 
 (23 to 84) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      15  36.6% 
Male      26  63.4% 
Race/Ethnicity, Customized 
[Units: Participants]
 
Caucasian   41 
Region of Enrollment 
[Units: Participants]
 
United States   41 


  Outcome Measures

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

2.  Primary:   4 Month Progression-free Survival   [ Time Frame: 4 months ]

3.  Secondary:   Overall Survival   [ Time Frame: From the initial date of treatment to the recorded date of death, assessed up to 5 years ]

4.  Secondary:   Summarized Toxicities   [ Time Frame: Up to 5 years ]

5.  Secondary:   Impact of the VEGF Trap Therapy on Laboratory Correlates   [ Time Frame: Up to 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: DCC Project Administrator
Organization: California Cancer Consortium
phone: 626-256-4673 ext 60094
e-mail: CCCP@coh.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00450255     History of Changes
Other Study ID Numbers: NCI-2009-00182
NCI-2009-00182 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PHII-77
CDR0000535719
PHII-77 ( Other Identifier: City of Hope )
7522 ( Other Identifier: CTEP )
N01CM62209 ( U.S. NIH Grant/Contract )
P30CA033572 ( U.S. NIH Grant/Contract )
First Submitted: March 20, 2007
First Posted: March 22, 2007
Results First Submitted: April 22, 2014
Results First Posted: February 4, 2015
Last Update Posted: April 24, 2018