An Exploratory Correlative Study of Biomarkers in Patients With Metastatic Renal Cell Carcinoma Who Have Progressed After Sunitinib Therapy

NCT00538772

Last updated date
Study Location
BC Cancer Agency - Centre for Southern Interior
Kelowna, British Columbia, V1Y 5L3, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- All patients enrolled from Canadian centres for the Wyeth Pharmaceuticals sponsored multicenter, open-label phase III study evaluating second line therapy with either temsirolimus or sorafenib in patients progressing after sunitinib therapy, are eligible for this correlative studies protocol.

- Patients must provide written informed consent.

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Advanced Information
Descriptive Information
Brief Title An Exploratory Correlative Study of Biomarkers in Patients With Metastatic Renal Cell Carcinoma Who Have Progressed After Sunitinib Therapy
Official Title An Exploratory Correlative Study of Biomarkers in Patients With Metastatic Renal Cell Carcinoma Who Have Progressed After Sunitinib Therapy
Brief Summary

Purpose:

The purpose of the correlative studies is to evaluate levels of serum factors of circulating VEGF and soluble VEGFR, circulating tumor cells and circulating endothelial cells assayed at baseline and over the course of initial treatment in order to explore relationships with baseline patient factors, measurable disease response and clinical progression.

Hypothesis soluble markers of angiogenic growth factors and receptors, and circulating endothelial and tumor cells can serve as markers for biologic activity of temsirolimus and/or sorafenib.

Detailed Description It is recognized that the measurable disease RECIST criteria response rate with mTOR inhibition is likely to be low and that the benefit of such therapy will also include effects on disease stabilization. Disease stabilization is difficult to interpret in the phase II setting. Thus, it is desirable to develop biomarkers which will provide additional information on novel treatment effects and how they might relate to disease progression
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

Approx. 40ml of blood for correlative studies will be drawn at predetermined time points: baseline, after cycle 1, at time of treatment failure/discontinuation of protocol therapy.

10 unstained slides from original patient specimen (nephrectomy specimens only) will be collected within 6 months after enrollment.

Sampling Method Non-Probability Sample
Study Population Subjects from Canadian centres who have agreed to participate in the trial entitled "A randomized trial of Temsirolimus and Sorafenib as second line therapy in patients with advanced renal cell carcinoma who have failed first line Sunitinib therapy" will be approached to participate in this Exploratory Biomarker study
Condition Carcinoma, Renal Cell
Intervention Other: Not applicable - blood tests/tissue specimen tests will be undertaken
Not applicable - blood tests/tissue specimen tests will be undertaken
Study Groups/Cohorts Biomarker
Intervention: Other: Not applicable - blood tests/tissue specimen tests will be undertaken
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: July 9, 2019)
0
Original Estimated Enrollment
 (submitted: October 2, 2007)
50
Actual Study Completion Date November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All patients enrolled from Canadian centres for the Wyeth Pharmaceuticals sponsored multicenter, open-label phase III study evaluating second line therapy with either temsirolimus or sorafenib in patients progressing after sunitinib therapy, are eligible for this correlative studies protocol.
  • Patients must provide written informed consent.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT00538772
Other Study ID Numbers KNC-001
Biomarkers
Metastatic Renal Cell
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Kim Chi, British Columbia Cancer Agency
Study Sponsor Kim Chi
Collaborators Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator:Christian Kollmannsberger, MDBC Cancer Agency- Vancouver
PRS Account British Columbia Cancer Agency
Verification Date July 2019