A Phase II Trial of Perifosine Following Tyrosine Kinase Inhibitor (TKI) - Failure in Patients With Renal Cancer

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AEterna Zentaris
• Collaborator: Dana-Farber Cancer Institute

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)