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

Advanced Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01443390
• Other study ID #: SCRI-CA_004
• Status: Completed
• Phase: N/A
• First received: September 27, 2011
• Last updated: May 12, 2014
• Start date: September 2011
• Est. completion date: March 2013

Study information

• Verified date: May 2014
• Source: Scottsdale Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Advanced Cancer

Locations

Country	Name	City	State
United States	Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare	Scottsdale	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Scottsdale Healthcare	National Foundation for Cancer Research, Translational Genomics Research Institute, Phoenix, Arizona.

Country where clinical trial is conducted

United States, 

References & 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 adva — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No