An Ancillary Pilot Trial Using Whole Genome Sequencing In Patients With Advance Refractory Cancer

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.

The investigators have a new tool which warrants early exploration for what role it might eventually play in the process of selecting the best therapy for an individual patient. The basis of the current ancillary exploratory study is to gain initial experience with the operational aspects of this whole genome sequencing in this setting.

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Key information

Conditions

Advanced Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare

Scottsdale, Arizona, 85258, United States

About this study

To measure the time from biopsy to completion and final analysis of Whole Genome Sequencing (WGS) on patient tumor and non-tumor samples.
To examine the frequency with which useable sequence data is obtained as a function of tumor volume received and percent tumor involvement in the biopsy
To identify the frequency with which potential targets and pathways for therapy are discovered.
To observe for any evidence that if anti-tumor activity from treatment is noted how would the genome sequencing have correlated with that activity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Scottsdale Healthcare

Other

Collaborators

National Foundation for Cancer Research
Translational Genomics Research Institute

Registry information

Official study title

An Ancillary Pilot Trial Using Whole Genome Sequencing In Patients With Advanced Refractory Cancer

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Sep 29, 2011
Registry last updated: May 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed