N/A
N=20
Molecular Profiling in Guiding Individualized Treatment Plan in Adults With Recurrent/Progressive Glioblastoma
Adult Glioblastoma
Bottom Line
View on ClinicalTrials.gov: NCT02060890 ↗Enrolled (actual)
20
Serious AEs
28.6%
Results posted
Dec 2017
Primary outcome: Primary: Number of Participants Who Received Treatment Recommendations Within 35 Days of Surgery — 15 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- specialized tumor board recommendation (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Received Treatment Recommendations Within 35 Days of Surgery |
15 | — |
| SECONDARY Number of Patients Who Chose to Pursue Treatment |
7 | — |
Summary
This current study will use a new treatment approach based on each patient's tumor genomic profiling consisting of whole genome sequencing, exome analysis, and RNA sequencing as well as predictive modeling. This new treatment strategy has shown promising results in adult patients with other solid tumors.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02060890). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.