An Exploratory Correlative Study of Biomarkers in Patients With Metastatic Renal Cell Carcinoma Who Have Progressed After Sunitinib Therapy
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Carcinoma, Renal Cell |
Other: Not applicable - blood tests/tissue specimen tests will be undertaken |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | An Exploratory Correlative Study of Biomarkers in Patients With Metastatic Renal Cell Carcinoma Who Have Progressed After Sunitinib Therapy |
- This is an exploratory study. Correlations between biomarkers and baseline factors and treatment outcomes will be made
Biospecimen Retention: Samples With DNA
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.
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2008 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Biomarker |
Other: Not applicable - blood tests/tissue specimen tests will be undertaken
Not applicable - blood tests/tissue specimen tests will be undertaken
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
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.
Contacts and Locations| Canada, British Columbia | |
| BC Cancer Agency - Centre for Southern Interior | |
| Kelowna, British Columbia, Canada, V1Y 5L3 | |
| BC Cancer Agency - Vancouver | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| BC Cancer Agency - Vancouver Island | |
| Victoria, British Columbia, Canada, V8R 6V5 | |
| Principal Investigator: | Christian Kollmannsberger, MD | BC Cancer Agency- Vancouver |
More Information
No publications provided
| Responsible Party: | Dr Kim Chi, BC Cancer Agency -Vancouver Centre |
| ClinicalTrials.gov Identifier: | NCT00538772 History of Changes |
| Other Study ID Numbers: | KNC-001, Biomarkers, Metastatic Renal Cell |
| Study First Received: | September 28, 2007 |
| Last Updated: | November 3, 2010 |
| Health Authority: | Canada: Health Canada |
Keywords provided by British Columbia Cancer Agency:
|
Metastatic Renal Cell Carcinoma Biomarkers Biomarkers in patients with Metastatic Renal Cell Carcinoma Who Have Progressed After Sunitinib Therapy |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases |
Urologic Diseases Sunitinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013