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

NCT02060890 | Completed Results DMC

• 2 other identifiers: CC14101NCI-2017-00467
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult Glioblastoma

Keywords

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who 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.

  35 days from surgery to making genomic informed treatment recommendation

Secondary Outcomes (1)

• Number of Patients Who Chose to Pursue Treatment

  Within 35 days from surgery to making genomic informed treatment recommendation

Other Outcomes (2)

• Successful Generation of Patient-derived Xenograft (PDX) Genomic Models

  Within 12 months after tissue collection

• Number of Participants Reaching 12 Months Progression Free Survival

  12 month progression free survival

Study Arms (1)

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.

Other: specialized tumor board recommendation

Interventions

specialized tumor board recommendation OTHER

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

Also known as: standard of care therapy

Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients presenting with recurrent or progressive glioblastoma that are eligible for surgical resection.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Translational Genomics Research Institute: collaborator
• The Ben & Catherine Ivy Foundation: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

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

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Results Point of Contact

• Title: Nicholas Butowski MD Professor of Neuro-Oncology
• Organization: University of California, San Francisco

Thelma.Munoz@ucsf.edu

414-353-2966

Study Officials

• Michael Prados, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: February 12, 2014
• Study Start: August 1, 2014
• Primary Completion: September 3, 2015
• Study Completion: May 10, 2017
• Last Updated: December 12, 2023
• Results First Posted: December 6, 2017

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)