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 : July 28, 2020
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|Condition or disease||Intervention/treatment|
|Adult Glioblastoma||Other: specialized tumor board recommendation|
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||A Pilot Trial Testing the Feasibility of Using Molecular Profiling to Guide an Individualized Treatment Plan in Adults With Recurrent/Progressive Glioblastoma|
|Actual Study Start Date :||August 2014|
|Actual Primary Completion Date :||September 3, 2015|
|Actual Study Completion Date :||May 10, 2017|
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.
Other: specialized tumor board recommendation
feasibility of a specialized tumor board to come up with treatment recommendations no later than 35 days from surgery.
Other Name: standard of care therapy
- Number of Participants Who Received Treatment Recommendations Within 35 Days of Surgery [ Time Frame: 35 days from surgery to making genomic informed treatment recommendation ]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.
- Number of Patients Who Chose to Pursue Treatment [ Time Frame: 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
- Successful Generation of Patient-derived Xenograft (PDX) Genomic Models [ Time Frame: Within 12 months after tissue collection ]Number of patient-derived xenograft (PDX) models successfully derived from patient tumor samples.
- Number of Participants Reaching 12 Months Progression Free Survival [ Time Frame: 12 month progression free survival ]Treatment efficacy derived from specialized Tumor Board suggestion, defined by 12 month progression free survival.
Biospecimen Retention: Samples With DNA
Surgery is done and a "core" specimen (from the enhancing component of tumor) and one or more tissue biopsies of the surrounding "rim" are obtained and processed for shipment to TGen for NGS and transcriptome profiling.
Blood is obtained prior to and 24 hours following surgery for assessment of any circulating tumor DNA in blood.
Blood for circulating tumor DNA is collected every 28 days (+/- 7 days).
Whole blood samples will be immediately sent to Ashion for extraction of DNA. Isolated DNA will be quantitated by spectrophotometry, and the distribution of molecular weights in the preparations will be visualized by gel electrophoresis. Blood derived DNA samples will be aliquoted and kept at Ashion at -20 degrees Celsius until use in molecular studies
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- Patients must understand and provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization prior to initiation of any study-specific procedures
- Have a life expectancy of at least 3 months
- Patients must have a diagnosis of histologically confirmed Glioblastoma that is felt on imaging to be progressive despite standard of care treatment
- at least 18 years of age
- Patient is a good medical candidate for a standard of care surgical procedure
- Patients may enroll independent of number of prior therapies, but must have received prior radiation therapy
- Patients must have a performance status (KPS) of at least 60.
- Uncontrolled concurrent illness including psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent
Eligibility for treatment using the specialized Tumor Board recommendations
- Patients must have fully recovered from any toxicity associated with surgery
- Must begin treatment no longer than 35 calendar days from surgery
- Must have KPS at least 60
- Must have Absolute Neutrophil Count (ANC) at least 1500/mm3, platelets at least 125,000/mm2, Hg at least 8 gm/dl
- Must have electrolytes (Na, K, Co2, Cl) within normal limits using institutional guidelines
- Must have baseline MRI within 14 days prior to starting cycle 1, day 1 of treatment (+/- 3 days)
- Additional laboratory guidelines will be based upon therapies suggested by the specialized Tumor Board based upon anticipated, known toxicities of those agents and must be within at least 1.5 x upper normal limits of institutional normal limits
- Patient must agree to follow the recommended treatment regimen, including clinic visits, laboratory, imaging, and toxicity assessments
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060890
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Michael Prados, MD||University of California, San Francisco|
|Responsible Party:||Nicholas Butowski, Professor, Neuro-Oncology, University of California, San Francisco|
|Other Study ID Numbers:||
NCI-2017-00467 ( Registry Identifier: CTRP (Clinical Trial Reporting Program )
|First Posted:||February 12, 2014 Key Record Dates|
|Results First Posted:||December 6, 2017|
|Last Update Posted:||July 28, 2020|
|Last Verified:||July 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
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