An Ancillary Pilot Trial Using Whole Genome Sequencing In Patients With Advance Refractory Cancer
1 other identifier
observational
11
1 country
1
Brief Summary
When a patient with advanced cancer consults with a member of the Phase I drug development team, the investigators utilize all information possible to try to select a therapy for that patient which has the best chance of working for them. This information includes:
- 1.Past published information
- 2.Clinical experience and judgement
- 3.Immunohistochemistry for specific targets (e.g., ER)
- 4.Standard sequencing (e.g., for K-Ras) and other methods now available.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 27, 2011
CompletedFirst Posted
Study publicly available on registry
September 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedMay 14, 2014
May 1, 2014
1.5 years
September 27, 2011
May 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
to identify as many genomic changes as possible in advanced cancers, so as to expand the range of potential actionable targets with therapies that were commercially available or clinical trials
12 months
Eligibility Criteria
Patients with advanced refractory cancer
You may qualify if:
- Have a life expectancy of greater than 3 months.
- Patients must have a diagnosis of histologically or cytologically confirmed advanced incurable cancer which has progressed on one or more prior chemotherapeutic, hormonal or biological regimens for advanced disease.
- Be a good medical candidate for and willing to undergo a biopsy or surgical procedure to obtain tissue, which may or may not be part of the patient's routine care for their malignancy.
You may not qualify if:
- Patients with symptomatic CNS metastasis.
- Known HIV, HBV or HCV infection requiring antiviral therapy.
- Pregnant or breast-feeding patients or any patient with childbearing potential not using adequate contraception.
- Inaccessible tumor for biopsy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Scottsdale Healthcarelead
- National Foundation for Cancer Researchcollaborator
- Translational Genomics Research Institutecollaborator
Study Sites (1)
Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare
Scottsdale, Arizona, 85258, United States
Related Publications (1)
Weiss GJ, Liang WS, Demeure MJ, Kiefer JA, Hostetter G, Izatt T, Sinari S, Christoforides A, Aldrich J, Kurdoglu A, Phillips L, Benson H, Reiman R, Baker A, Marsh V, Von Hoff DD, Carpten JD, Craig DW. A pilot study using next-generation sequencing in advanced cancers: feasibility and challenges. PLoS One. 2013 Oct 30;8(10):e76438. doi: 10.1371/journal.pone.0076438. eCollection 2013.
PMID: 24204627RESULT
Biospecimen
Biopsy of an accessible lesion
Study Officials
- PRINCIPAL INVESTIGATOR
Glen J Weiss, M.D.
Scottsdale Healthcare
Study Design
- Study Type
- observational
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Clinical Research
Study Record Dates
First Submitted
September 27, 2011
First Posted
September 29, 2011
Study Start
September 1, 2011
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
May 14, 2014
Record last verified: 2014-05