Status:
COMPLETED
A Phase II Trial of Perifosine Following Tyrosine Kinase Inhibitor (TKI) - Failure in Patients With Renal Cancer
Lead Sponsor:
AEterna Zentaris
Collaborating Sponsors:
Dana-Farber Cancer Institute
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a single-arm phase II trial of perifosine in renal cancer patients who have experienced disease progression after receiving either sorafenib or sunitinib.
Detailed Description
This is a single-arm phase II trial assessing the antitumor activity as measured by progression free survival of perifosine in patients with metastatic RCC who have progressed on sorafenib or sunitini...
Eligibility Criteria
Inclusion
- Patients will be required to have clear cell renal cell carcinoma with less than 50% of any other histology (papillary or chromophobe or oncocytic). There must be histologic confirmation by the treating center of either the primary or a metastatic lesion
- Patients must have experienced disease progression by RECIST criteria while on sorafenib or sunitinib
- Patients must be off of sorafenib or sunitinib for \>= 2 weeks prior to initiation of perifosine and \<= 3 months prior to enrollment
- Patients may have had sorafenib or sunitinib in the adjuvant setting as long as they have experienced disease recurrence while on therapy
- Patients must have measurable disease that is not curable by standard radiation therapy or surgery
- Age \>= 18 years
- ECOG performance status 0 or 1
- \- Patients must have the ability to understand and willingness to sign a written informed consent document
Exclusion
- History or clinical evidence of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastasis, or history of stroke
- Other than sorafenib or sunitinib, patients may have only had prior immunotherapy for stage IV disease
- Patients may have had prior sorafenib OR sunitinib and cannot have been treated with both TKIs
- Patients who have stopped sorafenib or sunitinib due to toxicity but have only progressed off therapy will not be allowed
- Patients may have had prior anti-angiogenic such as bevacizumab only if given in combination with either sorafenib or sunitinib
- Prior Thalidomide or IFNα are allowed for adjuvant therapy or stage IV disease
- Patients may not have had prior mTOR inhibitors (CCI-779, RAD001)
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00448721
Start Date
March 1 2007
End Date
October 1 2011
Last Update
March 1 2018
Active Locations (4)
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1
Investigative Site
Duarte, California, United States, 91010
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Investigative Site
Philadelphia, Pennsylvania, United States, 19104
4
Investigative Site
Nashville, Tennessee, United States, 37232