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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01443390
Recruitment Status : Completed
First Posted : September 29, 2011
Last Update Posted : May 14, 2014
National Foundation for Cancer Research
Translational Genomics Research Institute
Information provided by (Responsible Party):
Glen Weiss, Cancer Treatment Centers of America

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.

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.

Condition or disease
Advanced Cancer

Detailed Description:
  1. To measure the time from biopsy to completion and final analysis of Whole Genome Sequencing (WGS) on patient tumor and non-tumor samples.
  2. 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
  3. To identify the frequency with which potential targets and pathways for therapy are discovered.
  4. To observe for any evidence that if anti-tumor activity from treatment is noted how would the genome sequencing have correlated with that activity.

Study Type : Observational
Actual Enrollment : 11 participants
Official Title: An Ancillary Pilot Trial Using Whole Genome Sequencing In Patients With Advanced Refractory Cancer
Study Start Date : September 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Primary Outcome Measures :
  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 [ Time Frame: 12 months ]

Biospecimen Retention:   Samples With DNA
Biopsy of an accessible lesion

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with advanced refractory cancer

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01443390

United States, Arizona
Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
Sponsors and Collaborators
Scottsdale Healthcare
National Foundation for Cancer Research
Translational Genomics Research Institute
Principal Investigator: Glen J Weiss, M.D. Scottsdale Healthcare

Publications of Results:
Responsible Party: Glen Weiss, Director, Clinical Research, Cancer Treatment Centers of America Identifier: NCT01443390     History of Changes
Other Study ID Numbers: SCRI-CA_004
First Posted: September 29, 2011    Key Record Dates
Last Update Posted: May 14, 2014
Last Verified: May 2014

Keywords provided by Glen Weiss, Cancer Treatment Centers of America:
Whole genome sequencing
Advanced Refractory Cancer