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

• ClinicalTrials.gov Identifier: NCT02060890
• Recruitment Status: Completed
• First Posted: February 12, 2014
• Results First Posted: December 6, 2017
• Last Update Posted: July 28, 2020
• Sponsor: University of California, San Francisco
• Collaborators: Translational Genomics Research Institute; The Ben & Catherine Ivy Foundation
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Treatment Group
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

Baseline Characteristics

Arm/Group Title		Group A
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.
Overall Number of Baseline Participants		20
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%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Received Treatment Recommendations Within 35 Days of Surgery
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

Outcome Measure Data

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
Arm/Group Description:	[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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Group
Arm/Group Description:	[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
Description	Number of patient-derived xenograft (PDX) models successfully derived from patient tumor samples.
Time Frame	Within 12 months after tissue collection

Outcome Measure Data

Analysis Population Description

Nine patients had sufficient tissue sent for PDX model development.

Arm/Group Title	Treatment Group
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
Description	Treatment efficacy derived from specialized Tumor Board suggestion, defined by 12 month progression free survival.
Time Frame	12 month progression free survival

Outcome Measure Data

Analysis Population Description

Number of patients who chose to pursue treatment based on genomic informed recommendations

Arm/Group Title	Treatment Group
Arm/Group Description:	[Not Specified]
Overall Number of Participants Analyzed	7
Measure Type: Count of Participants; Unit of Measure: Participants
	2 28.6%

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Group A
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%)
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
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%)

Limitations and Caveats

[Not Specified]

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: Nicholas Butowski MD Professor of Neuro-Oncology
• Organization: University of California, San Francisco
• Phone: 414-353-2966
• EMail: Thelma.Munoz@ucsf.edu

• Responsible Party: Nicholas Butowski, University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT02060890
• Other Study ID Numbers: CC14101; NCI-2017-00467 ( Registry Identifier: CTRP (Clinical Trial Reporting Program )
• 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: July 28, 2020