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

This study has been completed.
Sponsor:
Collaborators:
National Foundation for Cancer Research
Translational Genomics Research Institute, Phoenix, Arizona.
Information provided by (Responsible Party):
Glen Weiss, Cancer Treatment Centers of America
ClinicalTrials.gov Identifier:
NCT01443390
First received: September 27, 2011
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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
Advanced Cancer

Study Type: Observational
Official Title: An Ancillary Pilot Trial Using Whole Genome Sequencing In Patients With Advanced Refractory Cancer

Resource links provided by NLM:


Further study details as provided by Scottsdale Healthcare:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biopsy of an accessible lesion


Enrollment: 11
Study Start Date: September 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with advanced refractory cancer

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01443390

Locations
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, Phoenix, Arizona.
Investigators
Principal Investigator: Glen J Weiss, M.D. Scottsdale Healthcare
  More Information

Publications:
Responsible Party: Glen Weiss, Director, Clinical Research, Cancer Treatment Centers of America
ClinicalTrials.gov Identifier: NCT01443390     History of Changes
Other Study ID Numbers: SCRI-CA_004
Study First Received: September 27, 2011
Last Updated: May 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Scottsdale Healthcare:
Whole genome sequencing
Advanced Refractory Cancer

ClinicalTrials.gov processed this record on October 29, 2014