Trial Outcomes & Findings for Molecular Profiling in Guiding Individualized Treatment Plan in Adults With Recurrent/Progressive Glioblastoma (NCT NCT02060890)

NCT ID: NCT02060890

Last Updated: 2023-12-12

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 20 participants
• Primary outcome timeframe: 35 days from surgery to making genomic informed treatment recommendation
• Results posted on: 2023-12-12

Participant Flow

Participant milestones

Measure	Treatment Group 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 Study STARTED	20
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Group A n=20 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 35 days from surgery to making genomic informed treatment recommendation

Population: 16 pts had tumor tissue for analysis; 15 of 16 patients received treatment recommendations within 35 days of surgery.

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.

Outcome measures

Measure	Group A n=16 Participants
Number of Participants Who Received Treatment Recommendations Within 35 Days of Surgery	15 Participants

SECONDARY outcome

Timeframe: Within 35 days from surgery to making genomic informed treatment recommendation

Number of patients who chose to pursue treatment based on these genomics-informed treatment recommendations

Outcome measures

Measure	Group A n=15 Participants
Number of Patients Who Chose to Pursue Treatment	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 12 months after tissue collection

Population: Nine patients had sufficient tissue sent for PDX model development.

Number of patient-derived xenograft (PDX) models successfully derived from patient tumor samples.

Outcome measures

Measure	Group A n=9 Participants
Successful Generation of Patient-derived Xenograft (PDX) Genomic Models	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 month progression free survival

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

Treatment efficacy derived from specialized Tumor Board suggestion, defined by 12 month progression free survival.

Outcome measures

Measure	Group A n=7 Participants
Number of Participants Reaching 12 Months Progression Free Survival	2 Participants

Adverse Events

Group A

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group A n=7 participants at risk Patients pursuing treatment after tumor board's genomics-informed treatment recommendation.
Respiratory, thoracic and mediastinal disorders Lung infection	14.3% 1/7 • Number of events 1
Nervous system disorders seizure	28.6% 2/7 • Number of events 2
Skin and subcutaneous tissue disorders Skin Infection	14.3% 1/7 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Nicholas Butowski MD Professor of Neuro-Oncology

University of California, San Francisco

Phone: 414-353-2966

Email: Thelma.Munoz@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place