Using Genomic Analysis to Guide Individual Treatment in Glioblastoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-12

Study Completion Date

2017-07-07

Brief Summary

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The purpose of this study is to assess whether the use of genomics can help identify patient specific treatment choices in cancer. In order to test this, the investigators plan to use genomic sequencing technology to identify patient specific mutations in glioblastoma multiforme (GBM) as compared to normal cells to identify mutations. Further analysis will identify potential treatment targets and whether there are any drugs that could be used for these particular mutations. Follow up clinical data will be assessed to see if this individualized method of choosing treatment options can improve clinical outcomes in patients with GBM.

Detailed Description

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The purpose of the study is to assess whether the use of genomics can identify patient specific treatment choices in glioblastoma (GBM) that improves clinical outcomes over standard of care. GBM is a devastating disease, the most common primary brain tumor and the most aggressive. With current standard therapy, which includes surgery, radiation therapy, and chemotherapy with temozolomide, the median survival is only 14.6 months. Once patients fail temozolomide, there are no other proven therapies, although other chemotherapies, bevacizumab, and tyrosine kinase inhibitors are often tried. Because tumors are different between patients, outcomes vary among patients. For example, temozolomide, though recommended to all patients with GBM as the only chemotherapy to improve survival, is also known not to be effective in patients with o6-methylguanine-DNA-methyltransferase (MGMT) unmethylated tumors. This example underscores the idea that if each tumor is different, and that perhaps there would be better outcomes if each tumor was treated uniquely.

Genomic sequencing is a technology that can be employed to identify specific characteristics of each tumor as compared to healthy cells. Since 2008, genomic sequencing technology has advanced significantly, having entered the era of next generation sequencing, and simultaneously, the cost of using this technology has dramatically decreased, nearing the cost of some currently used diagnostic tests such as MRI. In this study, the investigators plan to assess the usefulness of this technology and its analysis as a method of guiding treatment choices for the individual patient with GBM.

The investigators plan to sequence tumor/normal from GBM patients to identify mutations. The mutations will be analyzed for potential drug targets for treatment and recommendations for treatment will be suggested if any are identified. If the clinician implements the recommendations, clinical follow up data will be collected. The investigators will compare clinical outcomes, such as survival to historical controls undergoing standard of care treatment to assess whether this genomic guided, individualized therapy determination improves these measures.

In addition, the investigators plan to use next generation sequencing methods to determine whether the presence of brain messenger ribonucleic acid (mRNA) and miRNA can be detected in the peripheral blood and whether there is biological relevance to their presence if detected.

Conditions

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Glioblastoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Glioblastoma

Observational study, no intervention

Intervention Type OTHER

Observational study, no intervention

Interventions

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Observational study, no intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed glioblastoma multiforme
* Enough tumor tissue available from initial surgery to obtain at least 5 ug DNA and 5 ug RNA
* Sufficient blood sample to obtain 5 ug DNA and 5 ug RNA
* Karnofsky score at least 60
* Life expectancy at least 6 months

Exclusion Criteria

* Subjects not interested in further treatment of their brain tumor

Minimum Eligible Age

3 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Darnell, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rockefeller University

Locations

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