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Trial record 36 of 230 for:    "Anaplastic oligodendroglioma"

A Randomized Phase II Trial of Vandetanib (ZD6474) in Combination With Carboplatin Versus Carboplatin Alone Followed by Vandetanib Alone in Adults With Recurrent High-Grade Gliomas

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ClinicalTrials.gov Identifier: NCT00995007
Recruitment Status : Completed
First Posted : October 14, 2009
Results First Posted : March 29, 2016
Last Update Posted : March 29, 2016
Sponsor:
Information provided by (Responsible Party):
Katherine E. Warren, M.D., National Institutes of Health Clinical Center (CC)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Glioblastoma Multiforme
Gliosarcoma
Anaplastic Astrocytoma
Anaplastic Oligodendroglioma
Anaplastic Mixed Oligoastrocytoma
Interventions: Drug: ZD6474 (Vandetanib)
Drug: Carboplatin

  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
Carboplatin Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
Vandetanib With Carboplatin

ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.

Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.


Participant Flow:   Overall Study
    Carboplatin   Vandetanib With Carboplatin
STARTED   56   56 
Crossover to Vandetanib   42   0 
COMPLETED   39   54 
NOT COMPLETED   17   2 
Withdrew consent                1                0 
Refused further treatment                8                2 
Toxicity                8                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.
No text entered.

Reporting Groups
  Description
Carboplatin Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
Vandetanib With Carboplatin

ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.

Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.

Total Total of all reporting groups

Baseline Measures
   Carboplatin   Vandetanib With Carboplatin   Total 
Overall Participants Analyzed 
[Units: Participants]
 56   56   112 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   53   52   105 
>=65 years   3   4   7 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.29  (13.29)   50.10  (12.43)   50.13  (12.81) 
Gender 
[Units: Participants]
     
Female   19   15   34 
Male   37   41   78 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   0   0   0 
Not Hispanic or Latino   55   56   111 
Unknown or Not Reported   1   0   1 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   1   1 
Asian   0   1   1 
Native Hawaiian or Other Pacific Islander   1   0   1 
Black or African American   1   2   3 
White   53   52   105 
More than one race   0   0   0 
Unknown or Not Reported   1   0   1 
Region of Enrollment 
[Units: Participants]
     
United States   56   56   112 


  Outcome Measures

1.  Primary:   Progression Free Survival at 6 Months   [ Time Frame: 6 months ]

2.  Secondary:   Overall Survival   [ Time Frame: Time between the first day of treatment and the day of death, up to 1.5 years ]

3.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 70 months and 19 days ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Dr. Katherine E. Warren
Organization: National Cancer Institute
phone: 301-435-4683
e-mail: warrenk@box-w.nih.gov


Publications of Results:
A randomized phase II trial of Vandetanib (ZD6474) in combination with carboplatin versus carboplatin alone in adults with recurrent glioblastoma. Katherine McNeill, Fabio Iwamoto, Teri Kreisl, Joohee Sul, Joanna Shih, Howard Fine, New York University, New York, NY, USA, Columbia University, New York, NY, USA, National Institutes of Health, Bethesda, MD, USA, Food and Drug Administration, Silver Spring, MD, USA.
A randomized phase II trial of Vandetanib in combination with carboplatin versus carboplatin alone followed by Vandetanib aline in adults with recurrent anaplastic astrocytoma. Prakash Ambady, Katherine Warren, Joanna Shih, Teri Kreisl, Howard Fine, National Institutes of Health, Bethesda, MD, USA.

Other Publications:

Responsible Party: Katherine E. Warren, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00995007     History of Changes
Other Study ID Numbers: 090222
09-C-0222
First Submitted: October 10, 2009
First Posted: October 14, 2009
Results First Submitted: December 9, 2015
Results First Posted: March 29, 2016
Last Update Posted: March 29, 2016