Using Genomic Analysis to Guide Individual Treatment in Glioblastoma

NCT02725684 | Completed

• 1 other identifier: RDA-0837
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Identification of targetable variants in the tumor

  Identification of variants in each tumor that are potential drug targets

  6 months

Study Arms (1)

Glioblastoma

Observational study, no intervention

Other: Observational study, no intervention

Interventions

Observational study, no intervention OTHER

Observational study, no intervention

Glioblastoma

Eligibility Criteria

• Age: 3 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with glioblastoma

You may qualify if:

• 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

You may not qualify if:

• Subjects not interested in further treatment of their brain tumor

Sponsors & Collaborators

• Rockefeller University: lead
• Memorial Sloan Kettering Cancer Center: collaborator
• Lenox Hill Hospital: collaborator
• North Shore University Hospital: collaborator
• NYU Langone Health: collaborator
• Weill Medical College of Cornell University: collaborator
• Albert Einstein College of Medicine: collaborator
• New York Genome Center: collaborator

Study Sites (7)

New York University Langone Medical Center

New York, New York, 10016, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10017, United States

Location

Rockefeller University

New York, New York, 10065, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

North Shore University Hospital

New York, New York, 11030, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (4)

• Gormally E, Caboux E, Vineis P, Hainaut P. Circulating free DNA in plasma or serum as biomarker of carcinogenesis: practical aspects and biological significance. Mutat Res. 2007 May-Jun;635(2-3):105-117. doi: 10.1016/j.mrrev.2006.11.002. Epub 2007 Jan 25.

  PMID: 17257890 BACKGROUND

• Hegi ME, Diserens AC, Godard S, Dietrich PY, Regli L, Ostermann S, Otten P, Van Melle G, de Tribolet N, Stupp R. Clinical trial substantiates the predictive value of O-6-methylguanine-DNA methyltransferase promoter methylation in glioblastoma patients treated with temozolomide. Clin Cancer Res. 2004 Mar 15;10(6):1871-4. doi: 10.1158/1078-0432.ccr-03-0384.

  PMID: 15041700 BACKGROUND

• Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.

  PMID: 15758009 BACKGROUND

• Wrzeszczynski KO, Frank MO, Koyama T, Rhrissorrakrai K, Robine N, Utro F, Emde AK, Chen BJ, Arora K, Shah M, Vacic V, Norel R, Bilal E, Bergmann EA, Moore Vogel JL, Bruce JN, Lassman AB, Canoll P, Grommes C, Harvey S, Parida L, Michelini VV, Zody MC, Jobanputra V, Royyuru AK, Darnell RB. Comparing sequencing assays and human-machine analyses in actionable genomics for glioblastoma. Neurol Genet. 2017 Jul 11;3(4):e164. doi: 10.1212/NXG.0000000000000164. eCollection 2017 Aug.

  PMID: 28740869 DERIVED

Related Links

• Wetterstrand KA. DNA Sequencing Costs: Data from the NHGRI Genome SequencingProgram (GSP)

Biospecimen

Retention: SAMPLES WITH DNA

Unused samples retained

MeSH Terms

Conditions

Glioblastoma

Interventions

Observation

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

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Robert Darnell, MD, PhD

  Rockefeller University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: April 1, 2016
• Study Start: March 12, 2015
• Primary Completion: July 7, 2017
• Study Completion: July 7, 2017
• Last Updated: October 25, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share

Locations

US (7)