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

NCT ID: NCT02060890

Last Updated: 2023-12-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2017-05-10

Brief 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.

Detailed Description

Patients with recurrent glioblastoma who are candidates for surgery for their clinical management will have tumor tissue taken at the time of surgery. Tissue samples will be obtained from the contrasting edge as well as infiltrating margins. Circulating tumor DNA will also be taken from blood samples before, and after surgery and every 2 months. Genomic profiling of the tumor tissue will be performed and a Molecular Tumor Board will review the profiling within 28 to 35 days of surgery. If specific potential targets are amenable to treatment, a treatment recommendation will be made. Up to 4 drugs could be suggested to the treating physician. The patient and the treating physician may or may not choose to use the recommendation. Any drug from the US Pharmacopeia may be chosen. If the treatment as suggested is given, patients will be followed for toxicity and efficacy, including progression and survival. If the treatment is not given, patients will be followed for progression and survival.

Conditions

Adult Glioblastoma

Keywords

Glioblastoma

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Group A

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

Intervention Type: OTHER

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

Interventions

specialized tumor board recommendation

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

Intervention Type: OTHER

Other Intervention Names

standard of care therapy

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Translational Genomics Research Institute

OTHER

Sponsor Role: collaborator

The Ben & Catherine Ivy Foundation

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Prados, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

NCI-2017-00467

Identifier Type: REGISTRY

Identifier Source: secondary_id

CC14101

Identifier Type: -

Identifier Source: org_study_id