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Trial record 41 of 230 for:    "Anaplastic oligodendroglioma"

VEGF Trap in Treating Patients With Recurrent Malignant Gliomas That Did Not Respond to Temozolomide

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ClinicalTrials.gov Identifier: NCT00369590
Recruitment Status : Completed
First Posted : August 29, 2006
Results First Posted : October 2, 2015
Last Update Posted : October 2, 2015
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: Adult Anaplastic Astrocytoma
Adult Anaplastic Oligodendroglioma
Adult Giant Cell Glioblastoma
Adult Gliosarcoma
Recurrent Adult Brain Tumor
Interventions: Biological: ziv-aflibercept
Other: pharmacological study
Other: laboratory biomarker analysis

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients (pts) were enrolled from Feb 2007 - Nov 2008. pts were from seven different cancer centers and were recruited from their outpatient cancer centers.

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 - Anaplastic Glioma

Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

Other: pharmacological study; laboratory biomarker analysis.

ziv-aflibercept: Given IV

pharmacological study: correlative studies

laboratory biomarker analysis: correlative studies

Arm 2 - Glioblastoma

Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

Other: pharmacological study; laboratory biomarker analysis.

ziv-aflibercept: Given IV

pharmacological study: correlative studies

laboratory biomarker analysis: correlative studies


Participant Flow:   Overall Study
    Arm I - Anaplastic Glioma   Arm 2 - Glioblastoma
STARTED   16   42 
COMPLETED   16   42 
NOT COMPLETED   0   0 



  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.
16 patients were anaplastic gliomas and 42 were glioblastomas all underwent central pathologic review

Reporting Groups
  Description
Arm I - Anaplastic Glioma

Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

Other: pharmacological study; laboratory biomarker analysis.

ziv-aflibercept: Given IV

pharmacological study: correlative studies

laboratory biomarker analysis: correlative studies

Arm 2 - Glioblastoma

Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

Other: pharmacological study; laboratory biomarker analysis.

ziv-aflibercept: Given IV

pharmacological study: correlative studies

laboratory biomarker analysis: correlative studies

Total Total of all reporting groups

Baseline Measures
   Arm I - Anaplastic Glioma   Arm 2 - Glioblastoma   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   42   58 
Age 
[Units: Years]
Median (Full Range)
 53 
 (26 to 70) 
 55 
 (33 to 72) 
 54 
 (26 to 72) 
Gender 
[Units: Participants]
     
Female   5   25   30 
Male   11   17   28 
Karnofsky Performance Status [1] 
[Units: Units on a scale]
Median (Full Range)
 90 
 (60 to 100) 
 90 
 (60 to 100) 
 90 
 (60 to 100) 
[1]

The Karnofsky Performance Scale Index allows patients to be classified as to their functional impairment.

100-80: Able to carry on normal activity and to work; No special care needed.

70-50: Unable to work; able to live at home and care for most personal needs; varying amount of assistance needed

40-10: Unable to care for self; Requires equivalent of institutional or hospital care; diseases may be progressing rapidly.

0: Dead

Pathology 
[Units: Participants]
     
Glioblastoma   0   39   39 
Gliosarcoma   0   3   3 
Anaplastic astrocytoma   12   0   12 
anaplastic oligodendroglioma   3   0   3 
Anaplastic mixed oligoastrocytoma   1   0   1 


  Outcome Measures

1.  Primary:   Progression-free Survival (PFS) at 6 Months   [ Time Frame: 6 months ]

2.  Primary:   Safety Profile - Toxicities   [ Time Frame: Start to End of treatment 39 cycles or 1yr 7.5months (78 weeks) ]

3.  Primary:   Safety Profile - Events That Discontinued Treatment   [ Time Frame: Approximately 1 year (start of treatment - end of treatment) ]

4.  Secondary:   Response Rate Associated With VEGF Trap Therapy Defined as Proportions of Patients Experiencing Complete or Partial Response   [ Time Frame: Up to 2 years ]

5.  Secondary:   Progression Free Survival (PFS) Rate for Subjects With Radiographic Response   [ Time Frame: up to 3 years ]

6.  Secondary:   Overall Survival   [ Time Frame: 3 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
No text entered.


  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: Stuart A Grossman, MD Director of ABTC
Organization: Adult Brain Tumor Consortium
phone: 410-955-8837
e-mail: grossman@jhmi.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00369590     History of Changes
Other Study ID Numbers: NCI-2009-00677
NCI-2009-00677 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000495275
NABTC06-01 ( Other Identifier: Adult Brain Tumor Consortium )
NABTC-06-01 ( Other Identifier: CTEP )
U01CA062399 ( U.S. NIH Grant/Contract )
First Submitted: August 24, 2006
First Posted: August 29, 2006
Results First Submitted: June 3, 2015
Results First Posted: October 2, 2015
Last Update Posted: October 2, 2015