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Trial record 19 of 1110 for:    Recruiting, Not yet recruiting, Active, not recruiting, Completed, Enrolling by invitation, Approved for marketing Studies | glioblastoma

Molecular Profiling in Guiding Individualized Treatment Plan in Adults With Recurrent/Progressive Glioblastoma (TGEN)

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ClinicalTrials.gov Identifier: NCT02060890
Recruitment Status : Completed
First Posted : February 12, 2014
Results First Posted : December 6, 2017
Last Update Posted : November 8, 2018
Sponsor:
Collaborators:
Translational Genomics Research Institute
The Ben & Catherine Ivy Foundation
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Nicholas Butowski, University of California, San Francisco

Study Type Observational
Study Design Observational Model: Other;   Time Perspective: Prospective
Condition Adult Glioblastoma
Intervention Other: specialized tumor board recommendation
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Group
Hide Arm/Group Description

Patients will undergo collection of tumor at the time of tumor resection and after confirmation of tumor progression and will have blood samples drawn pre-surgery and during standard of care follow-up visits. Patients will then be provided with a specialized tumor board recommendations for personalized treatment options for up to 4 medications based on the specimen analysis results within 35 days of surgery. Patients may then elect to initiate recommended therapy within 42 days of surgery.

specialized tumor board recommendation: feasibility of a specialized tumor board to come up with treatment recommendations no later than 35 days from surgery.

Period Title: Overall Study
Started 20
Completed 16
Not Completed 4
Arm/Group Title Group A
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Patients will undergo collection of tumor at the time of tumor resection and after confirmation of tumor progression and will have blood samples drawn pre-surgery and during standard of care follow-up visits. Patients will then be provided with a specialized tumor board recommendations for personalized treatment options for up to 4 medications based on the specimen analysis results within 35 days of surgery. Patients may then elect to initiate recommended therapy within 42 days of surgery.

specialized tumor board recommendation: feasibility of a specialized tumor board to come up with treatment recommendations no later than 35 days from surgery.

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
15
  75.0%
>=65 years
5
  25.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
7
  35.0%
Male
13
  65.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
1
   5.0%
Not Hispanic or Latino
15
  75.0%
Unknown or Not Reported
4
  20.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
15
  75.0%
More than one race
0
   0.0%
Unknown or Not Reported
5
  25.0%
1.Primary Outcome
Title Number of Participants Who Received Treatment Recommendations Within 35 Days of Surgery
Hide Description To demonstrate feasibility, we would want the treatment recommendation to be fully complete within 35 calendar days in at least 85% of patients for which sufficient RNA and DNA is available.
Time Frame 35 days from surgery to making genomic informed treatment recommendation
Hide Outcome Measure Data
Hide Analysis Population Description
16 pts had tumor tissue for analysis; 15 of 16 patients received treatment recommendations within 35 days of surgery.
Arm/Group Title Group A
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[Not Specified]
Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
15
  93.8%
2.Secondary Outcome
Title Number of Patients Who Chose to Pursue Treatment
Hide Description Number of patients who chose to pursue treatment based on these genomics-informed treatment recommendations
Time Frame Within 35 days from surgery to making genomic informed treatment recommendation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group
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[Not Specified]
Overall Number of Participants Analyzed 15
Measure Type: Count of Participants
Unit of Measure: Participants
7
  46.7%
3.Other Pre-specified Outcome
Title Successful Generation of Patient-derived Xenograft (PDX) Genomic Models
Hide Description Number of patient-derived xenograft (PDX) models successfully derived from patient tumor samples.
Time Frame Within 12 months after tissue collection
Hide Outcome Measure Data
Hide Analysis Population Description
Nine patients had sufficient tissue sent for PDX model development.
Arm/Group Title Treatment Group
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
5
  55.6%
4.Other Pre-specified Outcome
Title Number of Participants Reaching 12 Months Progression Free Survival
Hide Description Treatment efficacy derived from specialized Tumor Board suggestion, defined by 12 month progression free survival.
Time Frame 12 month progression free survival
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients who chose to pursue treatment based on genomic informed recommendations
Arm/Group Title Treatment Group
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 7
Measure Type: Count of Participants
Unit of Measure: Participants
2
  28.6%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A
Hide Arm/Group Description Patients pursuing treatment after tumor board's genomics-informed treatment recommendation.
All-Cause Mortality
Group A
Affected / at Risk (%)
Total   0/7 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Group A
Affected / at Risk (%) # Events
Total   2/7 (28.57%)    
Nervous system disorders   
seizure  [1]  2/7 (28.57%)  2
Respiratory, thoracic and mediastinal disorders   
Lung infection  [2]  1/7 (14.29%)  1
Skin and subcutaneous tissue disorders   
Skin Infection   1/7 (14.29%)  1
Indicates events were collected by systematic assessment
[1]
Seizure
[2]
Lung infection
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group A
Affected / at Risk (%) # Events
Total   0/7 (0.00%)    
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
Layout table for Results Point of Contact information
Name/Title: Nicholas Butowski MD Professor of Neuro-Oncology
Organization: University of California, San Francisco
Phone: 414-353-2966
EMail: Thelma.Munoz@ucsf.edu
Layout table for additonal information
Responsible Party: Nicholas Butowski, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02060890     History of Changes
Other Study ID Numbers: CC14101
NCI-2017-00467 ( Registry Identifier: CTRP (Clinical Trial Reporting Program )
P30CA082103 ( U.S. NIH Grant/Contract )
First Submitted: February 7, 2014
First Posted: February 12, 2014
Results First Submitted: June 1, 2017
Results First Posted: December 6, 2017
Last Update Posted: November 8, 2018